Sökresultat för "Biotech"

Bohus Biotech is an innovative company focused on the development and manufacture of high-quality products containing hyaluronic acid (HA). We are now in an expansive phase, investing in the products and processes of the future. We are looking for a driven Process Engineer who wants to become part of Bohus’s future and contribute to the continued development of hyaluronic acid and its products. As our Process Engineer, you will be responsible for developing, optimizing, validating, and maintaining manufacturing processes to ensure product quality, process robustness, regulatory compliance, and operational efficiency. The role supports both existing production processes and the introduction of new products and technologies. You will be working closely with dedicated and highly competent colleagues within Production, Quality Assurance, Regulatory Affairs, Supply Chain, and R&D. You will get the exciting opportunity to build, shape and optimize our processes and apply your experience and expertise to ensure the highest manufacturing standards. If this sounds interesting to you - Come join us! This is a full-time position and based in our company location in Strömstad, Sweden. On-site in Strömstad preferred, but hybrid solutions are possible for the right candidate. We will interview candidates continuously and welcome your application today. Key responsibilities The Process Engineer is responsible for ensuring that manufacturing processes are robust, efficient, validated, and compliant throughout the product lifecycle. You will bridge day-to-day manufacturing support with longer-term process development and operational excellence initiatives. The position reports to the COO. Duties and responsibilities include: Develop, implement, and continuously improve manufacturing processes to enhance quality, yield, and efficiency. Lead root cause investigations and implement corrective and preventive actions (CAPA). Plan, execute, and document validation activities, including Process Validation, Equipment Qualification (IQ/OQ/PQ), Cleaning Validation, and Test Method Validation/Verification. Provide technical support to production, investigating process deviations, non-conformities, and out-of-specification results. Lead continuous improvement initiatives using structured problem-solving methods such as Root Cause Analysis, FMEA, and 5 Why. Ensure processes comply with ISO 13485, EU MDR 2017/745, ISO 14971, and GMP principles. Support audits and inspections by customers, regulatory authorities, and Notified Bodies. Support technology transfers from R&D to production and participate in cross-functional development projects. Approve process validation documentation according to delegated authority and escalate process risks impacting product quality, compliance, or supply. Skills and Competencies The suitable candidate has the following qualifications: Formal academic degree level (BSc. or MSc.) in chemical engineering, biotechnology, pharmaceutical science or related. Strong background in process engineering preferably combined with validation engineering experience. Experience working in a manufacturing environment within a regulated industry (e.g. Medical Devices, Pharmaceuticals, Biotechnology, or other regulated industries). Experience with process optimization, process validation and problem solving. Experience with sterile processes, equipment qualification (IQ, OQ, PQ), process validation, troubleshooting, and continuous improvement would be highly valuable. Experience working with Quality Management Systems. Knowledge of statistical analysis and process capability concepts. Excellent communication and documentation skills in English are required The successful candidate for this position will be someone who: Has a strong technical and analytical mindset. Enjoys solving complex manufacturing and process-related challenges. Is structured and detail-oriented. Takes ownership and drives improvements independently. Communicates effectively across departments and organizational levels. Combines hands-on problem solving with a systematic approach. Thrives in a fast-paced environment where quality, compliance, and operational performance are equally important. We offer a dynamic working environment with significant opportunity to make an impact — contributing to Bohus’s success as well as your own growth and development. About Bohus Biotech Founded in 1993, BOHUS has been at the forefront of Hyaluronic Acid (HA) development and manufacturing for over three decades. Our journey began with a vision to revolutionize the HA industry through innovation and commitment to excellence. With more than 30 years of expertise, the company has established a strong international presence with products distributed to hospitals, clinics, and physicians in over 60 countries worldwide. Bohus Biotech focuses exclusively on high quality hyaluronic acid technologies across three therapeutic areas: Ophthalmology – OVD solutions supporting tissue protection during cataract surgery Aesthetics – Dermal fillers based on the proprietary SHAPE™ technology platform Orthopaedics – Injectable treatments for osteoarthritis All research, development, and manufacturing are located in Strömstad, Sweden, ensuring full control over product quality and innovation. For more information, visit the company's web sites at: www.bohusbiotech.com For more information about this position, please contact: Krishan Johansson Haque, PhD Sr Recruitment Consultant, QRIOS Life Science & Engineering T: +46 (0)72-070 16 53 E: krishan.johansson-haque@qrios.se

About the company: Navinci is a Swedish biotech company developing innovative technologies to study protein interactions in their native spatial context, with a strong legacy in in situ proximity ligation assay technology and a broad portfolio of products for spatial proteomics. About the role: We are looking for a Senior Data Scientist in image analysis to join Navinci and build scalable, automated pipelines for spatial interactomics. You will take strong ownership in designing and advancing computational methods, with a focus on creating robust, reproducible workflows that incorporate rigorous quality control and leverage deep learning to address complex biological questions. The work will support both internal R&D and external collaborations. You will be part of a highly skilled, and growing team, playing a key role in advancing pipeline development and computational innovation. The role requires both independent problem-solving and effective collaboration in a dynamic environment, helping position Navinci at the forefront of spatial biology and emerging AI technologies. Key Responsibilities Design, develop, and maintain scalable, automated analysis pipelines and reproducible workflows with robust quality control for spatial interactomics data. Develop novel computational methods and apply deep learning to address complex biological questions and enable new analysis capabilities. Build internal tools and contribute to best practices in pipeline design, reproducibility, and code quality. Collaborate with multidisciplinary teams and external partners to translate biological problems into computational solutions. Mentor and guide junior team members while contributing to a collaborative, adaptive, and high-performing team environment. Work effectively in a dynamic environment with adaptability, independence, and strong collaboration, while staying current with advances in spatial omics and AI (e.g., agentic/LLM-based workflows). Qualifications Required: PhD in Computational Biology, Bioinformatics, Computer Vision, or a related field (or equivalent industry experience). Strong understanding of spatial omics data and associated analysis challenges. Demonstrated ability to design and develop robust, reproducible computational methods and pipelines, including components such as image processing, clustering, spatial analysis, statistical analysis and data visualization. Strong proficiency in Python, with experience developing production-quality code for data analysis and pipeline development. Proven, hands-on experience in developing and applying deep learning models, using machine learning frameworks (e.g., PyTorch, Scikit-learn). Ability to independently solve complex, open-ended problems. Strong communication and collaboration skills in interdisciplinary environments. Preferred: Industry experience in image analysis methods and/or pipeline development is a strong plus. Experience with agentic workflows, AI agents, or LLM-based systems. Experience applying best practices in scientific programming and/or software engineering (e.g., testing, debugging, version control, CI/CD). Experience with GPU programming and performance optimization. Experience with high-throughput computing such as HPC or cloud computing. Experience with tool development, UI/UX, or containerization (e.g., Docker). What We Offer Opportunity to shape scientific direction in a cutting-edge company. Agile teams with fast decision-making and direct impact. Dynamic environment with growth and leadership potential. Close collaboration across R&D, product, and commercial teams. Applications will be reviewed on a rolling basis.

Vi söker processingenjörer till uppdrag inom läkemedel och biotech i Stockholm/Uppsala. Rollen passar dig som vill arbeta med processutveckling, optimering och tech transfer i en regulatoriskt styrd miljö. Om rollen Du arbetar med utveckling och förbättring av tillverkningsprocesser. Exempel på arbetsuppgifter: Optimering av processer och flöden Tech transfer och uppskalning Root cause analysis och CAPA Samarbete med produktion, QA och R&D Processvalidering Vi söker dig som: Har erfarenhet av processarbete inom Life Science Har arbetat i GMP-miljö Har förståelse för tillverkningsprocesser Har analytisk problemlösningsförmåga Om verksamheten Du kommer att arbeta som konsult hos en av QRIOS partners inom Life Science, i en forskningsintensiv miljö där innovation och vetenskaplig excellens står i fokus. Teamet består av både juniora ingenjörer och seniora forskare som tillsammans driver projekt inom filtrering, rening och analytisk utveckling. Om QRIOS Life Science QRIOS är din pålitliga partner inom Life Science-sektorn. Vi är experter på rekrytering och konsultlösningar för specialist- och chefsroller inom läkemedel, medicinteknik, bioteknik, kemiteknik och livsmedelsteknik. Vår styrka ligger i att våra medarbetare själva har omfattande erfarenhet från branschen, vilket ger oss en unik förståelse för våra kunders behov och utmaningar. Som konsult hos QRIOS får du möjlighet att prova på olika uppdrag, utvecklas snabbt och bygga ett brett nätverk inom Life Science. Tillsammans driver vi innovation och bidrar till en bättre framtid.

Are you an experienced commercial partner to Pharma and Biotech clients? Cellectricon is looking for a Key Account Manager who can build trust with senior decision‑makers, open new doors globally and turn scientific potential into long-term commercial partnerships. About the position This position is a direct recruitment, which means that the process is managed by Bravura and you will be employed directly by Cellectricon. About the company Cellectricon is a Swedish biotech company of 20 employees based in Mölndal, specializing in early-stage neuroscience drug discovery. As a niche CRO, the company supports Pharma and Biotech clients with high-quality, physiologically relevant in vitro models, advanced assay development and specialized scientific expertise. Their mission is to help clients make more predictive and informed research decisions, reduce early-stage risk and identify promising therapeutic candidates. The team consists of researchers, project managers and technical specialists with strong scientific backgrounds. The culture is collaborative, transparent and non-hierarchical. Employees describe Cellectricon as a workplace where everyone is included, decisions are made quickly and scientific curiosity goes hand in hand with business thinking. Responsibilites In this role, you are responsible for both developing existing accounts and driving new business. You work closely with scientists, project managers and senior stakeholders both internally and externally. The sales process is consultative and often involves navigating complex customer organizations, understanding scientific challenges and building long-term strategic partnerships. You represent Cellectricon at international conferences, meet customers across Europe and the US, and drive the entire sales cycle — from creating initial interest to closing an agreement and ensuring a strong handover into delivery. Build, develop and manage relationships with global Pharma and Biotech clients Drive complex B2B sales processes from prospecting to signed agreement Perform scientific needs analyses and match customer challenges with Cellectricon’s scientific offering Navigate customer organizations and anchor decisions at the right level Collaborate closely with scientists, project management and operations throughout the customer journey Experience and personal qualities 5+ years of B2B sales experience within Pharma and/or Biotech Strong consultative and value-based sales skills Professional understanding of the drug discovery value chain, especially early preclinical phases Fluent in English, written and spoken Ability and willingness to travel internationally (~60 days per year) Experience from neuroscience is meritious You are analytical and curious, with an interest in understanding scientific contexts in order to create relevant discussions with both researchers and decision-makers. You ask the right questions, navigate complex organizations and drive the process forward with structure and initiative. You build trust, collaborate easily with colleagues and act with humility and professionalism. Your ability to combine strategic thinking with hands-on commercial execution makes you successful in this role. Other information Start: By agreement Location: Gothenburg (hybrid). Other locations possible with regular presence in Gothenburg Salary: Fixed + bonus, according to agreement Benefits: pension, wellness allowance, flexible working hours We use a competency‑based hiring methodology in all recruitment processes to ensure an unbiased and fair selection. We also work with continuous selection, which means that the advertisement may be taken down as soon as we have received a sufficient number of applications. If your profile matches the role, we will contact you for an initial phone interview. Regardless of the outcome, you will always receive feedback on your application. If you have any questions, you are welcome to contact us: 📧 info@bravura.se 📞 +46 (0)10‑171 47 10 We recommend submitting your application as soon as possible, as we review candidates on an ongoing basis. We look forward to receiving your application! #Specialist

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary of Job: The Associate Director, Scientific Communications, Rare Disease is responsible for supporting the development, execution, and continuous optimization of scientific communications initiatives for the Rare Disease Medical Affairs organization in North America. The role leads the planning, development, review, and implementation of scientific materials and educational programs that support Medical Affairs strategic objectives and ensure the accurate, balanced, and compliant dissemination of scientific information. Core focus of the role includes overseeing the development and lifecycle management of Field Medical materials; creating scientific content and supporting the execution of Medical Advisory Boards, Scientific Symposia, Medical Education initiatives, and conference-related deliverables; and managing external Medical Communications agencies and Medical Education partners to ensure the timely delivery of high-quality, scientifically accurate materials. The Associate Director collaborates cross-functionally with Medical Affairs and other internal stakeholders to ensure scientific communications activities are aligned with organizational priorities and compliant with applicable policies and regulatory requirements. Essential Functions: * Support data disclosure and scientific dissemination activities associated with clinical trial milestones and major medical congresses for U.S. Medical Affairs. * Provide content and editorial support for regional publications and scientific presentations. * Ensure regional publication priorities are represented in the global publication plan and support localization of global publication activities to meet regional needs. * Collaborate with global and regional Medical Affairs teams to ensure consistency of scientific messaging and alignment with regional medical strategy. * Partner with external medical communications agencies and vendors to manage the quality, timelines, and budgets of scientific communications deliverables. * Support external expert engagement and steering committee activities, including coordination of content review and approval workflows. * Support scientific and medical operations, including advisory board planning and execution, medical information initiatives, and Medical Science Liaison (MSL) training. * Represent Medical Affairs at Medical Review Committee (MRC) and Promotional Review Committee (PRC) meetings, as needed, ensuring materials are scientifically accurate, current, appropriately substantiated, and properly referenced. * Ensure all scientific communications activities are conducted in compliance with applicable SOPs, policies, regulatory requirements, ICMJE recommendations, Good Publication Practice (GPP) guidelines, and company compliance standards. * Perform additional duties and special projects as assigned. Job Requirements: Education Advanced degrees in life sciences, health sciences, pharmacy, medicine, nursing, or a related scientific discipline (MD, PharmD, PhD, DNP, or equivalent) required.  Experience * Minimum of seven (7) years in the pharmaceutical, biotechnology, or medical communications industry within Medical Affairs or Scientific Communications. * Minimum of three (3) years supporting Scientific Communications, Publications, or Medical Communications functions. * Demonstrated success developing and executing scientific communication initiatives, including field medical materials, advisory boards, scientific symposia, medical education programs, publications, and congress deliverables. * Proven ability to collaborate with cross-functional stakeholders and manage external medical communications agencies and vendors to deliver high-quality scientific materials. * Background supporting publication planning, scientific dissemination, and data disclosure activities associated with clinical development and medical congresses. * Familiarity with medical, promotional, and publication review processes within a regulated pharmaceutical or biotechnology environment. * Rare Disease experience is strongly preferred. Technical Skills * Working knowledge of scientific communications, publication planning, Good Publication Practice (GPP) guidelines, International Committee of Medical Journal Editors (ICMJE) recommendations, and applicable regulatory requirements. * Excellent written and verbal communication skills, with the ability to effectively communicate complex scientific information to diverse internal and external audiences and facilitate cross-functional collaboration. * Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), Microsoft Teams, and SharePoint. * Skilled in using Veeva Vault MedComms, Veeva PromoMats, publication management systems, and other platforms supporting scientific content development, review, approval, and distribution. * Strong scientific writing, editing, literature evaluation, and content development skills, with the ability to translate complex scientific information into clear, accurate, audience-appropriate materials. * Ability to leverage AI-enabled tools and platforms to support scientific content development, literature synthesis, data visualization, and operational efficiency while ensuring compliance with company policies and regulatory requirements. * Demonstrated project management and organizational skills, with the ability to manage multiple priorities and deliver high-quality work within established timelines. Non-Technical Skills Strong analytical skills, attention to detail, and ability to manage/prioritize multiple projects from concept to completion in a fast-paced environment.  Strong written and oral communication skills.  Ability to work well in cross-functional teams (across geography and culture) with a group of people with diverse skill sets and personalities.  Team player, flexible and adaptable. Ability to build good working relationships, both inside and outside the organization.  Self-starter.  Must possess integrity and be innovative in how they work on a day-by-day basis.  Has a passion for personal learning and development to be able to grow with the company.  Cultural sensitivity and ability to develop consensus within a multinational organization.  Physical Demands: Normal office environment with prolonged sitting and extensive computer work Working Conditions: Minimal domestic travel required (<10%), primarily for conference attendance or key meetings; occasional weekend travel may be required.   The anticipated salary for this position will be $180,000 to $196,900.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. This position requires being onsite two days a week in our Princeton, NJ HQ. This is note a remote opportunity. Summary of Job: The Senior Medical Director, Global Medical Affairs – Oncology is responsible for leading the development and execution of global medical affairs strategies for oncology programs, with a focus on myeloid malignancies. This role provides medical and scientific leadership across assigned assets and supports the integration of medical strategies with broader corporate objectives. The incumbent will lead global medical activities related to evidence generation, scientific communication, and external engagement, including collaboration with alliance partners and key external stakeholders. The position works cross-functionally with Clinical Development, Commercial, Regulatory, Market Access, and other internal teams to ensure alignment and effective execution of medical affairs initiatives. This role requires deep expertise in oncology and or hematology, strong strategic and analytical capabilities, and the ability to lead complex, cross-functional initiatives in a global environment. Essential Functions: * Lead the development and execution of global medical affairs strategies for assigned oncology assets, including pre-launch planning, lifecycle management, and long-term strategic initiatives focused on myeloid malignancies. * Serve as the primary global medical scientific lead for healthcare decision-makers and external stakeholders, facilitating scientific exchange regarding disease state management and the clinical and economic value of oncology products. * Collaborate cross-functionally with Clinical Development, Research & Development, HEOR, Market Access, Commercial, Regulatory, and other internal stakeholders to ensure alignment of medical strategies with corporate and portfolio objectives. * Lead integrated evidence generation strategies and medical data generation plans, including company-sponsored clinical trials, investigator-sponsored studies, and real-world evidence initiatives. * Provide strategic medical leadership for alliance partnerships by collaborating with partner companies to align on shared medical strategies, evidence generation activities, and external engagement plans across joint oncology programs. * Oversee the execution and quality of ongoing medical affairs studies and activities to ensure scientific rigor, compliance with regulatory requirements, and alignment with organizational objectives. * Identify evidence gaps, emerging scientific trends, and external insights to inform medical strategy, portfolio development, lifecycle planning, and stakeholder engagement activities. * Build and maintain strategic relationships with key opinion leaders (KOLs), healthcare systems, advocacy organizations, payer organizations, and other external stakeholders globally. * Represent the organization at scientific congresses, advisory boards, investigator meetings, and other external forums to communicate medical and scientific data and support organizational thought leadership in oncology. * Coordinate global medical affairs activities with alliance partners and internal stakeholders to support seamless execution of shared medical initiatives and external engagement strategies. * Provide leadership, coaching, and development for direct reports and/or junior medical affairs team members, including performance management, mentoring, and fostering a collaborative, high-performing team culture. * Supervise and manage assigned personnel, consultants, vendors, and external collaborators, as applicable, to ensure effective execution of medical affairs objectives and adherence to company policies and compliance standards. Job Requirements:  Education Medical Doctor. Board certification and/or subspecialty training in Oncology and/or Hematology preferred.  Experience * Minimum of 10 years of experience in Medical Affairs within the pharmaceutical and/or biotechnology industry, including significant experience in oncology; hematology and/or myeloid malignancy experience strongly preferred. * Combination of Global and Regional/Country Medical Affairs experience strongly preferred, including experience supporting global product strategy and execution. * Demonstrated experience developing and executing global medical affairs strategies across multiple stages of the product lifecycle, including pre-launch and post-launch activities. * Proven track record of leading cross-functional initiatives and influencing matrixed teams across Medical Affairs, Clinical Development, Commercial, HEOR, Market Access, and Regulatory functions. * Experience leading evidence generation activities, including company-sponsored studies, investigator-sponsored research, and/or real-world evidence initiatives. * Demonstrated success engaging with external stakeholders, including key opinion leaders (KOLs), healthcare decision-makers, advocacy organizations, and payer audiences in global markets. * Proven ability to collaborate effectively with alliance partners, external collaborators, and co-development/co-commercialization partners. * Strong people leadership capabilities, including mentoring, coaching, and direct management of medical affairs personnel and/or cross-functional teams. * Proven ability to represent the organization at scientific congresses, advisory boards, investigator meetings, and other external scientific forums. * Strong knowledge of HEOR disciplines, biostatistics, clinical trial design, and evidence-based medicine principles. * Exceptional interpersonal, communication, presentation, and organizational skills. * Strategic thinking with demonstrated ability to influence stakeholders across matrix environments.  Technical Skills * Strong knowledge of oncology medical affairs, including evidence generation, scientific exchange, and product lifecycle support within global markets. * Advanced understanding of HEOR disciplines, biostatistics, clinical trial design, real-world evidence, and evidence-based medicine principles. * Strong scientific acumen with the ability to interpret, analyze, and communicate complex clinical and scientific data to diverse stakeholder audiences.  Physical Demands: Normal office environment with prolonged sitting and extensive computer work. Working Conditions: Requires up to 35% domestic and international travel The anticipated salary for this position will be $256,800 to $335,400.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-JC1 #LI-Hybrid

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. The Executive Administrator performs and oversees all administrative related and selected operational services for the Global Head, Business Development ("GBDH"). Position requires broad understanding of corporate operations and policies. A high level of administrative and operational support and advanced computer technology experience is required. Ability to multi-task is essential. Must operate with discretion with internal and external executives and stakeholders, and exercise independent judgment and initiative.  Key Responsibilities:   * Works directly with C-level executives and other senior leaders; serves as a liaison for the Executive Committee and the Board of Directors as needed for GBD-related topics performing a wide range of administrative duties of a highly responsible and confidential nature. * Collaborate closely with other administrators, business leaders and global colleagues. * Support GBD with organizing and planning complex face-to-face and virtual internal and external / partner meetings and conferences across multiple time zones and demonstrate flexibility in work schedule to participate in these meetings. * Attend GBD Leadership Team ("GBD LT") meetings, prepare and maintain meeting notes. Manage data and prepare / support preparation of presentations as needed. * Exhibit a positive work attitude, high productivity and a collaborative approach with employees across an international environment. * Compose correspondence on behalf of GBDH from minimal information or written draft, utilizing tactful command of proper business writing and grammar; proof-read documents and presentations. * Coordinate and utilize travel procedures to complete domestic and international travel, process travel and expense reimbursement in a timely manner. * Comply with policies and procedures and manage the purchase order and requisition process related to supporting duties. * Suggest and drive improvement processes when applicable. * Support additional ad hoc assignments as requested   Qualifications: Education * A High School Diploma or GED required. * Business school, associate's degree or equivalent is a plus. Experience * A minimum of 8 years in a corporate environment; with pharmaceutical experience preferred. Technical Skills * Manage documents effectively from and to various software programs demonstrating a comfort level with various technologies and quickly learn technologies as necessary. * Proficient in MS Office Suite (MS Word, Excel, PowerPoint), Travel and Expense systems (e.g., Concur), and other relevant software. Non-Technical Skills * Executive-level communication skills (verbal and written); high discretion and professionalism in handling confidential matters; strong interpersonal skills and stakeholder relationship management. * Advanced organizational and multitasking capabilities; exceptional attention to detail and accuracy; effective prioritization and deadline management; sound judgment and decision-making ability. * Strong problem-solving skills and adaptability in ambiguous situations; flexibility and resilience in fast-paced, high-growth environments; proven ability to influence, collaborate, and drive consensus across global, multicultural teams. * Strong work ethic with accountability and consistent follow-through; proactive mindset with commitment to continuous learning and development The anticipated salary for this position will be $83,000 to $105,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

Arbetsuppgifter Cell Technology Group (CETEG, Dept. Industrial Biotechnology, CBH Skola, KTH, Stockholm), har en lång erfarenhet av utveckling av biofarmaceutiska och biologiska läkemedelsbioprocesser för humanterapi. CETEG:s ledare är Prof. Veronique Chotteau, som är Föreståndare av AdBIOPRO, en Competence Centre for Advanced Bioproduction by Continuous Processing, i samarbete med Lund University, Karolinska Institutet, Linköping University, Karolinska Sjukhus samt 15 svenska företag inom proteinläkemedel/bioteknik industri. I CETEGs verksamhet ingår bioprocessing av perfusion processer med väldigt hög celltäthet och fed-batch processer, metabolic flux analysis modellering och on-line process monitorering, alla inriktade mot processutveckling av industriell produktion av proteinläkemedel, virala vektorer eller humana celler för terapi. Gruppen, på 10 personer, är ett multidisciplinärt team, med forskare, post-docs samt doktorander och master studenter. CETEGs aktiviteter präglas av samarbete med akademiska grupper på KTH, i Sverige och i Europa samt internationella företag och SME. Cell Technology Group har nu en ledig vikariattjänst som Forskningsingenjör. Det praktiska arbetet kommer att ske på KTH, AlbaNova Centre. Forskningsingenjören kommer att stödja verksamheten av CETEG med följande uppgifter: Koordinering av labbfunktioner för olika labbaktiviteter, samt stöd för AdBIOPRO Stödja forskningsprojekt och uppdragsforskning, t. ex. odlingsprocess, analyser, reningsprocess, samt rapportering Kontakt med leverantör ang. utrustning och reagens samt tillämpning av regler enligt KTHs ramverk för beställningar, t. ex. upphandling- Kontakt med övriga grupper inom Industrial Biotechnology Avd. och CBH Skola ang. labverksamhet, miljögranskning och säkerhet Introduktion och utbildning för nybörjare samt praktik inom mammaliecell odling Register i bruk inom CETEG, t.ex. kemikalier inventering, cellbank Kvalifikationer Krav Avlagd examen på grundnivå eller avancerad nivå (högskoleutbildning), såsom civil ingenjör, inom bioteknik eller motsvarande kompetens Kunskap om odling av mammalieceller, inklusivt bioreaktor operation Behärska engelska skriftligt och muntligt då man arbetar i ett internationellt miljö och det krävs i det dagliga arbetet  Ämnesskicklighet Yrkesskicklighet. Medvetenhet om mångfalds- och likabehandlingsfrågor med särskild fokus på jämställdhet Självständighet Initiativtagande Personlig mognad God samarbetsförmåga Bra organisations- och planeringsförmåga Benägen att ta ansvar Bra förmåga för skriftlig rapportering Bra förmåga för strukturerat arbetssätt Meriterande  Behärska svenska skriftligt och muntligt då det är KTH:s myndighetsspråk  Vi kommer lägga stor vikt vid personliga egenskaper. Bli en del av KTH   KTH formar framtiden genom utbildning, forskning och innovation. Som ett ledande internationellt tekniskt universitet spelar vi en aktiv roll i att driva och medverka i omställningen till ett hållbart samhälle. Här erbjuds du möjligheten att växa och utvecklas på en kreativ och dynamisk arbetsplats med goda arbetsvillkor och förmåner. Jämställdhet, mångfald och lika villkor är en kvalitetsfråga och en självklar del av KTH:s värdegrund som universitet och statlig myndighet. Läs mer om våra förmåner och hur det är att arbeta och utvecklas på KTH. Fackliga representanter Kontaktuppgiftertill fackliga representanter.  Ansökan Du ansöker via KTH:s rekryteringssystem. Du som sökande har huvudansvaret för att din ansökan är komplett när den skickas in. Ansökan ska innehålla: CV inklusive relevant yrkeserfarenhet och kunskap. Kopia av examensbevis och betyg från dina tidigare universitetsstudier. Översättningar till engelska eller svenska om de ursprungliga dokumenten inte utfärdas på något av dessa språk. Personligt brev, max 2 sidor långt. Två referenser. Ansökan ska vara KTH tillhanda senast sista ansökningsdagen vid midnatt, CET/CEST (CentralEuropean Time/Central European Summer Time). Om anställningen  Anställningen gäller tidsbegränsat enligt avtal - i upp till ett år, med tillträde enligt överenskommelse. Övrigt För information om behandling av personuppgifter i samband med rekrytering. Det kan förekomma att en anställning hos KTH är placerad i säkerhetsklass. Om så är fallet för just denna anställning görs en säkerhetsprövning av sökande i enlighet med säkerhetsskyddslagen (2018:585) efter samtycke. I dessa fall är en förutsättning för anställning att sökande blir godkänd efter säkerhetsprövning. Vi undanber oss direktkontakt med bemannings- och rekryteringsföretag samt försäljare av platsannonser.

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations. Essential Functions: Risk-Based Quality Management (RBQM) Leadership •    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance. •    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors. •    Integrate RBQM principles into study planning, execution, oversight, and close-out activities. •    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy. Central Risk Identification, Monitoring & Mitigation •    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks. •    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials. •    Oversee centralized risk monitoring and trending to enable early detection of critical risks. •    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons  Learned & Risk Library Management (Core Ownership) •    Establish and maintain a centralized Clinical Risk Library, capturing: o    Known and emerging risks o    Root causes o    Mitigation strategies o    Effectiveness of controls •    Lead lessons learned activities across trials, audits, inspections, and CAPAs. •    Ensure lessons learned are: o    Systematically captured o    Analyzed for trends o    Fed back into RBQM planning, SOPs, training, and future studies •    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness. Quality Oversight & Regulatory Compliance •    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs. •    Provide centralized quality oversight across trials, CROs, and vendors. •    Support audit and inspection readiness activities, including: o    Risk-based inspection preparation o    Impact assessments o    CAPA development and effectiveness checks Vendor & CRO Risk Oversight •    Design and implement risk-based oversight strategies for CROs and external vendors. •    Monitor vendor performance using quality metrics and risk indicators. •    Lead or support quality governance discussions with external partners. •    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework. Data-Driven Quality & Continuous Improvement •    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making. •    Generate enterprise-level risk trend reports and insights for senior leadership. •    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned. •    Champion a culture of proactive quality and continuous improvement across Clinical Operations. Cross-Functional Collaboration & RBQM Expertise •    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance. •    Provide RBQM training and coaching to study teams and cross-functional stakeholders. •    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics. •    Participate as an observing member on assigned study teams to provide real-time quality and risk support. SOP Management & Governance Support •    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates. •    Support governance activities, senior management reporting, and quality metrics standardization. •    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support. Requirements: Education •    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required) •    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred) Experience •    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM •    Demonstrated experience leading enterprise or cross-study risk management frameworks •    Strong background in audit/inspection readiness, CAPA management, and vendor oversight •    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements Technical Skills •    Expertise with RBQM tools, centralized monitoring systems, and risk analytics •    Experience defining and using KRIs, QTLs, and quality metrics •    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI) •    Exposure to AI or predictive analytics for quality monitoring (preferred) Working Conditions: Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, ERP Functional & Solution Architect, ICT role will be responsible for overseeing MS D365 Enterprise Resource Planning (ERP) within the organization. Crucial role in implementing ERP specific business process improvements and enhancements within the organization and ensuring the system's optimal performance and functionality. Perform the planning, design, configuration, customization, and implementation of MS D365/ERP modules and functionalities, ensuring seamless integration with existing systems, ensuring compliance with industry standards, security protocols, and regulatory requirements. The ERP Functional Architect, Associate Director, ICT role will also serve as a business process analyst aligned with enterprise (i.e., SCM, MFG, Quality) and Corporate Functions (i.e., Finance, HR, Legal, Compliance, Procurement) ensuring successful technical solution development and delivery. Essential Functions: The D365 ERP F&O Functional Architect is responsible for the end-to-end functional design, configuration, and optimization of Microsoft Dynamics 365 Finance & Operations to support business operations across Finance, Procurement, Supply Chain, Manufacturing, Quality, and related business functions. The architect will partner with business stakeholders, technical teams, and implementation partners to ensure that the solution is aligned with corporate strategy, compliant with GxP/GAMP 5 standards (where applicable), and scalable for future business growth. 1. Solution Architecture & Design •    Lead the functional design and architecture of the D365 F&O solution across key modules (Finance, Supply Chain, Manufacturing, Procurement, Inventory, Quality, etc.). •    Translate complex business requirements into clear, scalable, and compliant functional solutions. •    Emphasizes proactive, holistic leadership in solution architecture. •    Focuses on aligning solutions with business goals, value streams, and enterprise architecture governance. •    Define data flows, integrations, and system interactions between D365 and other enterprise systems & interfaces (e.g., LIMS, MES, 3PL Partners, External Finance Systems, and Cloud systems). •    Ensure alignment with Microsoft’s Dynamics 365 roadmap and best practices. 2. Implementation & Configuration •    Perform and lead the setup, configuration, and deployment of D365 F&O modules.  •    End to end management of project/solution management by using tools like Azure Boards for planning and tracking work, Azure Repos for code versioning, and Azure Pipelines for automating build and deployment. Perform all activities from initial user stories and tasks to code, testing, and deployment through integrations with tools like Lifecycle Services (LCS).  •    Drive fit-gap analysis and functional documentation. Develop User/Functional Requirements, Functional/Technical Design, System/Business process architecture diagrams. •    Collaborate with development/vendor/managed service teams to define functional specifications for enhancements, bug/fix, customizations, reports, and interfaces. Co-develop or individually develop code/configurations required and coordinate internal development and user acceptance testing of the solution. •    Participate in system validation activities, including IQ/OQ/PQ documentation for regulated environments. 3. Governance & Compliance •    Ensure the ERP system design complies with GAMP 5, SOX, and GxP regulatory requirements. •    Develop and maintain master data governance, change management, and configuration control processes. •    Support audits and inspections through proper documentation and traceability. •    Develop current and future state roadmaps and architecture. •    Assess and align system release plan with Microsoft Dynamics 365 roadmap 4. Stakeholder Collaboration •    Partner with business process owners to define best practices, continuous improvement opportunities, and confirm desired solution to fix the support/bug-fix items raised. Support communities of practice and collaborative development methodology. •    Work independently to perform required fix within the D365 framework. Test and confirm the developed fix with business process owners.  •    Work closely with IT, OT, and cloud teams to ensure integrated digital architecture. •    Provide subject matter expertise and training for internal business process owners and super users. 5. Project & Vendor Management •    Support ERP implementation and upgrade projects through all phases — initiation, design, testing, go-live, and hypercare. •    Manage and coordinate external implementation partners and vendors. •    Define KPIs and monitor system performance, adoption, and ROI. Requirements: Education  Bachelor’s degree or equivalent experience in computer science, information systems, engineering, supply chain, or related fields required. Microsoft D365 F&O Certification preferred. Experience •    8+ years of experience implementing or supporting Microsoft Dynamics AX / D365 F&O. •    Proven expertise across multiple functional domains (Finance, Manufacturing, Supply Chain, Procurement). •    Experience designing integrations between ERP and external systems (LIMS, MES, Payment interface with Bank, External Finance Systems, etc.). •    Strong understanding of ERP data models, workflows, and reporting. •    Strong understanding of functional and solution architecture of, and experience performing code and configuration updates within the following Dynamics 365 modules: o    Finance: General ledger, Cash and bank management, Accounts payable, Accounts receivable. Budgeting, Fixed assets, Cost accounting, PR/PO process, Vendor Management, Cost Accounting and Management  o    SCM: Inventory management, Master planning, Procurement and sourcing, Product information management, Production control, Warehouse management, Cost accounting, Cost management, Asset management, including scheduled maintenance and repair tasks  Technical Skills •    Proficient in MS Office Suite. Experience with technology delivery applications across solutions such as (ERP, Manufacturing Execution Systems, Finance Systems, Control Tower).  •    Microsoft Certified: Dynamics 365: Finance and Operations Apps Solution Architect Expert certification preferred. •    Experience with emerging technologies (AI/ML, cloud, etc.) as relevant to ERP. Working Conditions: Requires up to 10 % domestic and international travel The anticipated salary for this position will be $165,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Senior Director, GRA Development & Product Strategy Team Lead is responsible for the developing and implementing regulatory strategies, while leading people amd managing global projects. This role oversees a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs. Essential Functions: •    Define and drive global regulatory strategies for all products within the assigned disease area, ensuring alignment with enterprise objectives and maximizing product value. •    Lead and develop a team of Global Regulatory Leads (GRLs), setting direction, building capabilities, and fostering a high-performance, accountable culture. •    Shape and integrate regulatory strategy into global product development and lifecycle plans in close partnership with cross-functional stakeholders. •    Oversee and ensure execution of regulatory strategies, including global submissions, approvals, and post-approval activities across assigned products and projects. •    Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution. •    Guide and approve global regulatory submission plans, including marketing applications, labeling (e.g., CCDS), and key lifecycle deliverables. •    Manage and coordinate regulatory activities, timelines, and deliverables across internal teams and external partners, ensuring alignment and on-time execution. •    Ensure compliance with global regulatory requirements, internal policies, and GxP standards, including support for inspections, audits, and governance processes. •    Assess and communicate regulatory risks, emerging trends, and competitive intelligence, escalating issues and recommending mitigation strategies as appropriate. •    Drive operational excellence by leading process improvements, standardization efforts (e.g., SOPs/WIs), and adoption of best practices across Regulatory Affairs. •    Oversee external partnerships and due diligence activities, including vendor selection, alliance management, and regulatory support for business development transactions. •    Contribute to organizational leadership, including participation in RA Functional Teams (RAFTs), budget oversight, and fostering collaboration across Regulatory Affairs and the broader organization. •    Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet (CCDS) development and alignment with regional labeling requirements. •    Allocate and optimize regulatory resources across the portfolio, ensuring effective prioritization and support for key business objectives. •    Recruit and build organizational capability by leading talent acquisition, succession planning, and ongoing training initiatives within the regulatory function. •    Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles, and the Global Regulatory Affairs Vision. Requirements: Education Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline required.  Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required; relevant industry experience may be considered in lieu of advanced education. Experience •    Minimum 12+ years extensive regulatory affairs experience within the pharmaceutical, biotechnology, or related industry, including global development and lifecycle management, with a focus on bone and mineral disease areas.  •    Proven leadership experience, including managing and developing high-performing regulatory teams and/or leading through other leaders (e.g., GRLs) •    Demonstrated success in developing and executing global regulatory strategies across multiple regions and product stages (development through post-approval) •    Significant experience interacting with health authorities, including leading regulatory agency meetings and negotiations •    Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations •    Experience supporting business development activities, including regulatory due diligence for in-licensing, out-licensing, or partnerships Strong collaboration across cross-functional teams including regulatory affairs, government affairs, clinical, legal, and R&D. Technical Skills •    Deep knowledge of global regulatory frameworks and guidelines, including major markets (e.g., FDA, EMA, ICH,PMDA) and their application to drug development and lifecycle management •    Expertise in regulatory submissions and approvals, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval variations •    Strong understanding of global labeling requirements, including development and maintenance of Company Core Data Sheets (CCDS) •    Advanced regulatory strategy development and risk management skills, with the ability to anticipate challenges and drive solutions •    Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness •    Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance •    Strong organizational and project management skills with the ability to manage multiple initiatives simultaneously. •    Exceptional communication and influencing skills, with the ability to clearly articulate complex regulatory strategies, risks, and requirements to diverse audiences, including health authorities, senior leadership, and cross-functional teams, to drive alignment and informed decision-making. •    Strong proficiency MS Office Suite. Working Conditions: Requires up to domestic and international travel. The anticipated salary for this position will be $265,000-$285,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible. The Manager, Global Service Readiness Engineering — CIBP is responsible for leading a team of service readiness engineers that ensures service readiness across the Cell & Gene Therapy (Sepax, Sefia, Xuri), Biacore, Imager, and Palltronics product portfolios — some of Cytiva's highest-revenue and most strategically important product lines. This role combines people leadership with hands-on service engineering expertise to deliver high-quality service deliverables on time across New Product Development (NPD) projects and Lifecycle Management (LCM) activities. This position reports to the Director, Global Service Engineering & Equipment Intelligence and is part of the Global Service Readiness Engineering organization located in Uppsala, Sweden or Portsmouth, UK and will be a onsite role. What you will do: Lead and develop a team of service readiness engineers — including hiring, onboarding, training, performance management, career development discussions, and establishing a regular cadence of 1:1s and staff meetings. Oversee and prioritize daily operations of the CIBP engineering team to ensure on-time delivery (OTD) and high quality of all service deliverables across NPD tollgates and LCM activities (~180 LCM tasks/month organization-wide). Drive service readiness in NPD projects — owning DFS (Design for Serviceability) scoring, Service Support Plans, EHS Risk Assessments, and spare parts (FRU) strategies for assigned product platforms at all tollgate stages. Manage lifecycle activities including service documentation updates, field modifications, engineering change orders, calibration procedures, and spare parts updates in collaboration with Service Operations, R&D, and Manufacturing. Act as Subject Matter Expert (SME) on all service aspects relating to the assigned CIBP product portfolio, serving as the primary interface between central functions (R&D, Manufacturing, QA) and regional service teams. Who you are: Bachelor's degree in Engineering, Life Sciences, Physics, or a related technical field — or equivalent combination of education and experience. Multiple years of relevant work experience in service engineering, field service, or product development within the life sciences or medical device industry. Demonstrated experience leading or supervising technical teams, including hiring, onboarding, performance management, and talent development. Experience working in cross-functional NPD or product lifecycle project teams, meeting tollgate deadlines and delivering against defined specifications. Working knowledge of quality management systems (e.g., ISO 13485, GMP/GxP, Veeva QMS) and design control processes. Fluency in English (written and spoken); Swedish language skills are a plus. It would be a plus if you also possess: Experience with PDM/PLM systems (e.g., Magic/Windchill) Familiarity with Danaher Business System (DBS) tools and methodologies Field service experience with bioprocess, chromatography, or analytical instruments

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At HemoCue, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. For more than four decades we’ve been advancing what’s possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count. Learn about the Danaher Business System which makes everything possible. The HR Site Lead, LER, is responsible for driving labor and employee relations at the HemoCue headquarters site in Ängelholm, ensuring a compliant, constructive, and high-performing work environment. This role is central in managing union relations, advising leaders on employment matters, and safeguarding adherence to Swedish labor law and internal policies. You will act as HR partner to leaders balancing business needs with legal and contractual obligations. As part of a global HR organization, you will collaborate closely with HR colleagues to ensure consistent, high-quality HR delivery while supporting a strong “one HR” approach in a matrix environment. As HR Site Lead, LER, you will proactively drive initiatives that strengthen employee relations and contribute to sustainable organizational performance. This role is based onsite in Ängelholm and reports to the Senior Director, Labor and Employee Relations, at Radiometer with a dotted line to Senior Director, HR at HemoCue. In this role, you will have the opportunity to: Act as a trusted advisor to managers on employee relations cases. Lead and manage labor relations, including union negotiations, consultations, and relationship management with both white- and blue-collar unions. Maintain high standards of HR data accuracy and reporting, ensuring compliance with our QMS and audit readiness. Provide compliance and reporting activities. Conduct onboarding and offboarding activities. Managing hosted associates. Manage and drive HR projects that align with business objectives. The essential requirements of the job include: Bachelor’s degree in Human Resources, Business Administration, or equivalent discipline. Proficiency in Swedish and English, written and verbally. 5+ years of HR experience with a strong focus on labor and employee relations Strong knowledge of Swedish employment law and collective bargaining frameworks Proven experience in leading union negotiations and managing relationships with multiple unions Excellent IT skills (Office Package, HR Systems, AI) Application We review applications on an ongoing basis and encourage you to submit yours as soon as possible. Please note that response time may be longer due to the summer holiday period. We look forward to hearing from you.

Arbetsbeskrivning Vill du vara med och bidra till utvecklingen av framtidens diagnostiska produkter? Har du erfarenhet av laboratoriearbete inom medicinteknik och trivs i en koordinerande roll med fokus på kvalitet? Nu söker vi på Randstad en driven och strukturerad labbingenjör för ett konsultuppdrag på 6 månader hos vår kund IDL Biotech. Tjänsten är på deltid (60 %, motsvarande ca 3 dagar i veckan) med start i slutet av augusti eller början av september. Om uppdraget och IDL Biotech Som labbingenjör hos IDL Biotech kliver du in i en dynamisk miljö där innovation möter strikta kvalitetskrav. IDL Biotech utvecklar och producerar diagnostiska produkter och snabbtester, med ett särskilt fokus på Point of Care (POC) inom onkologi och infektionssjukdom.. Att vara konsult hos Randstad Att arbeta som konsult via Randstad är en fantastisk möjlighet att bredda ditt nätverk, samla värdefull erfarenhet och kickstarta eller vidareutveckla din karriär inom industrin. Som konsult hos oss är du anställd av Randstad men utför ditt dagliga arbete ute hos vår kund. Du får en dedikerad konsultchef som stöttar dig i din utveckling, och du omfattas självklart av kollektivavtal, marknadsmässig lön, friskvårdsbidrag och tjänstepension. Ansvarsområden Genomföra laboratoriearbete och analyser enligt gällande regelverk för medicintekniska produkter (IVDR). Säkerställa att laborationer och tester genomförs effektivt och levereras inom uppsatta deadlines. Skriva och sammanställa protokoll samt rapporter på ett noggrant och regulatoriskt korrekt sätt. Arbeta fokuserat med Point of Care-produkter och snabbtester inom onkologi och infektionssjukdom. Kvalifikationer Utbildning: 3-årig högskole- eller universitetsutbildning (kandidatexamen) inom biomedicin, bioteknik eller motsvarande relevant område. Erfarenhet: 2–3 års praktisk erfarenhet från arbete inom life-science industrin. Kvalitetssystem: Erfarenhet av laboratoriearbete under kvalitetsledningssystem som GMP eller ISO. Språk: Mycket goda kunskaper i engelska. IT-verktyg: Goda kunskaper i Office-paketet. Meriterande: Tidigare erfarenhet av arbete specifikt med diagnostiska produkter och IVDR. Erfarenhet inom Point of Care (POC) lateral flow-tester. Vi lägger stor vikt vid personlig lämplighet för denna tjänst. Som person bör du vara flexibel, noggrann, ha god kommunikationsförmåga samt vara nyfiken, målmedveten och strukturerad. Det är viktigt att du har mycket god samarbetsförmåga och tar ansvar så att gruppen levererar enligt satta tidslinjer och kvalitetskrav. Vidare så ser vi gärna att du är metodisk samt initiativtagande och bidrar till ett positivt arbetsklimat. Om företaget Randstad På Randstad vet vi att alla människor har en plats på arbetsmarknaden. Med verksamhet över hela landet och inom alla kompetensområden hjälper vi människor att hitta ett jobb som känns bra, och där de får möjlighet att växa, utvecklas och uppnå sin fulla potential. Med närmare 600 000 anställda i 38 länder är Randstad världsledande inom HR-tjänster, med målsättningen att bli världens främsta och mest uppskattade partner på arbetsmarknaden. Genom att kombinera vår passion för människor med kraften i dagens teknologi hjälper vi människor och företag att uppnå deras fulla potential. Vi kallar det Human Forward.

Hansa Biopharma develops innovative treatments that give patients with rare and serious immune-mediated conditions a chance to a better life. We are now looking for an experienced Senior QA Manager Validation and Quality, to help shape our quality work at one of the most exciting biotech companies in the Nordics. About the role You will be a key player in a QA team of six dedicated colleagues, all based at our office in Lund. As Senior QA Manager, you will drive and approve validation activities - spanning process, cleaning and analytical method validation - with a clear quality perspective. You will act as subject matter expert supporting cross-functional teams, external partner management and regulatory authority inspections. This is the right role for you if you thrive with both strategic ownership and operational presence - where one day you are reviewing validation documentation and the next you are in dialogue with a CDMO or preparing a team for an authority inspection. Your responsibilities: Provide strategic and operational direction for quality management and validation across development, clinical and commercial manufacturing QA review and approval of validation documentation Supplier quality management: guide and qualify external manufacturing partners (CDMOs/CMOs) throughout the product lifecycle Support authority inspections and internal/external audits of suppliers and vendors Cross-functional collaboration with CMC, Regulatory, Clinical and Supply Chain Drive continuous improvement of the Quality Management System (QMS) and proactively identify areas for development Who are you? We believe you are a seasoned QA professional with broad experience across both drug substance (DS) and drug product (DP) manufacturing. You are thorough and results-oriented, but also a natural collaborator who knows when to take the lead and when to seek input from others. We are looking for someone with: Advanced degree (Ph.D. or M.Sc.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related discipline 10+ years of biopharmaceutical industry experience with a focus on QA, process development and validation Proven track record of leading validation activities for DS and DP through clinical and commercial stages Strong knowledge of aseptic manufacturing and biotechnology processes Deep understanding of regulatory requirements (FDA, EMA, ICH) related to manufacturing and validation Experience managing external partners and CDMOs/CMOs Experience of authority inspections (FDA, EMA) as presenter and/or coordinator Strong communication skills and the ability to influence across functions and organisational levels What we offer At Hansa, you will not just have a job - you will have a role where your work directly contributes to changing lives for patients with acute and complex immune disorders. A close-knit, welcoming culture in a mid-sized company where you can see how your contribution makes a difference The opportunity to help build a fully integrated biopharmaceutical company with global reach Talented, driven colleagues with an open and entrepreneurial mindset A strong pipeline built on Hansa’s proprietary IgG-cleaving enzyme technology platform Office in Lund, at the heart of a vibrant Life Science ecosystem Our values At Hansa, we are guided by our core values: Accountability, Courage, Integrity and Pioneering. We believe in the power of diversity and are committed to building an inclusive workplace where every perspective is valued. Appealing? Send in an application as soon as possible. In this recruitment, Hansa Biopharma is collaborating with SallyQ. For questions, please contact Ellinor Crafoord, Senior Recruitment Consultant, +46793554257 or ellinor.crafoord@sallyq.se.

Lab Technician – Extraction & Analytical Lab At Supernormal Greens, we develop high-performance active ingredients and botanical extracts for applications in cosmetics, nutraceuticals, and pharma. Our platform combines controlled plant cultivation with advanced extraction and analytical capabilities. As a Lab Technician at Supernormal Greens, you will be responsible for executing and supporting extraction and analytical workflows, while ensuring that the lab operates at a high technical standard. This is a hands-on role with significant ownership, where you will manage both daily lab activities and the performance of our analytical and extraction setup. Key Responsibilities Perform extraction of plant materials using lab-scale methods Conduct analytical measurements, including: Spectrophotometric assays HPLC LC-MS Take full responsibility for lab equipment, including: Calibration Maintenance Troubleshooting Performance monitoring Ensure reliable and reproducible execution of analyses and extraction processes Support method development and optimization in collaboration with the R&D team Maintain structured documentation of experiments, protocols, and results Contribute to building and improving lab workflows and standards Profile & Requirements Master’s degree in Analytical Chemistry, Chemistry, Biotechnology, or a related field Hands-on experience from an analytical or extraction lab environment Experience working with: HPLC and/or LC-MS Spectrophotometric methods Experience with lab equipment calibration, maintenance, and operation Ability to execute structured lab work with high accuracy and consistency Who You Are Curious and motivated to learn and explore new methods Comfortable working in an R&D environment with evolving processes Hands-on, responsible, and detail-oriented Able to balance execution with continuous improvement What You Will Be Part Of You will be part of the R&D team, working closely with scientists and engineers to develop new extraction processes and analytical methods. Your work will directly contribute to both internal research and commercial client projects, making you a key part of building our next-generation botanical active ingredient platform. Your Leader You will report to Erik Lundgren, co-founder and Head of R&D at Supernormal Greens. Working with Erik means working close to the core of how new ideas become real. He leads from the front in a fast-moving R&D environment where the goal is not to protect old assumptions, but to test, learn, and build what actually works. As a manager, Erik combines high expectations with trust and room to grow. He values ownership, curiosity, and practical problem-solving, and gives people real responsibility early. His leadership is shaped by three innovation principles: If it cannot be repeated, it does not count – results must be reliable and reproducible The plant always reveals the truth – decisions are driven by data, not assumptions Fast iterations beat slow certainty – progress comes from testing, learning, and adapting quickly That means you will be encouraged to move forward, run experiments, learn from the outcome, and adjust quickly. You will not be expected to have every answer from the start, but you will be expected to engage fully, take responsibility, and keep improving. How we Roll This is everything but normal core values. It’s the Supernormal way to unlock potential. For the planet. For the people we love. The Plant Comes First. We let the plant show us the way. We handle each plant with care and respect. We collect data and use it to make smart decisions. Human Growth. We grow as people by developing and learning new things. We respect each other by watching and listening. We give and ask for feedback. Zero Crap. We do things we are proud of. We don't waste time, resources or the environment. We say things like they are and live what we preach. We got Your Back. We dare to test, progress comes before perfection. We make development everyday by testing new things, evaluating and improving. We support each other's courage to challenge the normal.