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About Sobi Sobi is a biopharmaceutical company focused on improving the lives of people with rare diseases, primarily in hematology and immunology. In hematology, Sobi is a leader in Sweden, particularly in hemophilia care, striving to optimize treatment and support patients. In immunology, the company provides innovative treatments for rare immunological diseases with high unmet medical need. Sobi has expertise across the entire drug process, from clinical research to distribution. With a global headquarters in Stockholm, the company is present in over 30 countries and delivers treatments to patients in more than 70 countries, aiming to continue expanding. Are you an experienced HR professional with a passion for partnering with leaders, driving organizational change, and shaping people strategies in a global environment? Sobi is looking for an accomplished Global HR Business Partner to join the People & Communication team on a 12-month maternity leave cover. About the Role In this role, you will act as a trusted advisor to leaders and employees, helping to align People & Culture initiatives with business objectives while supporting a dynamic and international organization. As a Global HR Business Partner, you will play a key role in driving Sobi’s People & Communication agenda across corporate and functional teams. You will collaborate closely with business leaders and global stakeholders to ensure effective people strategies, organizational development, and employee engagement initiatives. Key Responsibilities Partner with leaders to align People & Culture priorities with business goals and organizational strategy Lead and support HR initiatives, transformation projects, and change management programs Provide strategic guidance on workforce planning, talent management, performance, and employee development Analyze HR data, identify trends, and provide actionable recommendations Act as an ambassador for HR processes, systems, and employee lifecycle activities Coach and support managers and employees on people-related matters Collaborate across functions and geographies to continuously improve HR practices Contribute to the development and success of the global People & Communication team Qualifications Bachelor's degree in Human Resources, Business Administration, or a related field Minimum 5 years of HR experience, preferably within global or multinational organizations Experience partnering with business leaders on strategic HR matters Experience leading HR initiatives, organizational development, or change management projects Fluent English, both written and spoken Your Profile To thrive in this role, you are a proactive and business-oriented HR professional who enjoys working closely with leaders to create meaningful business impact through people. You are comfortable navigating change, managing multiple priorities, and building strong relationships across functions and cultures. With a collaborative mindset and excellent communication skills, you easily establish trust and influence stakeholders at all levels of the organization. You are analytical and data-driven in your approach, while also bringing a pragmatic and solution-oriented mindset to your work. Most importantly, you are passionate about developing people, supporting leaders, and contributing to an inclusive, high-performing culture. Location: Stockholm Start: August 3, 2026 End: August 1, 2027 Workload: 100%
Join us as a Global Study Associate Director (GSAD) in our BioPharmaceuticals Clinical Operations team at AstraZeneca's dynamic R&D site in Gothenburg (Sweden). This role is pivotal in the delivery of clinical studies, providing direction and guidance to a cross-functional study team within the Cardiovascular, Renal and Metabolism (CVRM) therapy area. As the main liaison between the study team and the Clinical Program Team (CPT), you will be accountable for the delivery of a study according to agreed timelines, budget, and quality standards. Accountabilities As a GSAD, you will lead and provide guidance to a cross-functional study team, ensuring the clinical study progresses as planned. You will be responsible for developing essential study level documents, overseeing external service providers, and ensuring all systems used at a study-level are current and accurate. You will also oversee study level performance against agreed upon plans, milestones, and key performance indicators. Additionally, you will be responsible for study budget re-forecasting and management throughout the study lifecycle. Essential Skills/Experience University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research Relevant clinical experience in the pharmaceutical industry, including project management experience Extensive study management experience Extensive knowledge of ICH-GCP, clinical research regulatory requirements Demonstrated solid project management skills Strong abilities in team leadership with experience from cross-functional leadership of a clinical study or part of a clinical study Excellent communication and interpersonal skills Strong strategic and critical thinking abilities Ability to manage competing priorities Desirable Skills/Experience Advanced degree, master's level education (or higher) Project management certification Proven project management experience on a global level Experience in all phases of a clinical study lifecycle At AstraZeneca, we are driven by our passion for science and our commitment to making a difference. We fuse data and technology with the latest scientific innovations to achieve breakthroughs that have never been done before. Our inclusive environment allows us to work seamlessly as one, leveraging our diverse global knowledge to create the greatest impact on disease. We are constantly advancing our scientific knowledge to shape the future of healthcare and improve patient access to life-changing medicines. If you are ready to make a significant impact on patients' lives and push the boundaries of science, apply now! We welcome your application by Aug 16th, 2026.
Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn. In this role you will get the opportunity to work with committed colleagues in a collaborative team. Camurus is a rapidly growing and innovative company, and you will have a strong impact on the way we work with our outsourced manufacturing activities. We are looking for an experienced Senior Outsourcing Manager to join our Manufacturing Operations team. In this role, you will be responsible for driving outsourcing programs for injectable pharmaceutical products to Contract Manufacturing Organizations (CMOs), with a particular focus on late-stage development projects. As Senior Outsourcing Manager, you will serve as the primary interface between Camurus and external manufacturing partners. This is a true Project Management role where you will ensure successful project execution from technology transfer through start of commercial production. You will work closely with internal stakeholders and external partners to secure reliable, compliant, and efficient delivery of the project. You will report to the Director Manufacturing Operations. Main responsibility Among others, your responsibilities will include: · Develop and manage project plans, timelines, and milestones for technology transfer, process development, process validation, and manufacturing readiness activities together with CMO partners. · Drive day-to-day collaboration with CMOs and ensure agreed deliverables, timelines, and performance targets are achieved. · Lead operational meetings and steering committee meetings with external manufacturing partners. · Identify risks and issues proactively and drive mitigation and resolution activities together with internal and external stakeholders. · Coordinate and manage changes with CMOs, ensuring proper documentation, implementation, and alignment with project plans and contractual commitments. · Collaborate closely with internal Camurus functions such as Quality, R&D, Regulatory Affairs and Supply Chain to ensure successful project execution. · Ensure manufacturing activities are conducted in accordance with applicable GMP requirements and regulatory expectations. · Support continuous improvement initiatives related to outsourcing, external manufacturing operations, and CMO performance. Candidate profile We are looking for a professional with extensive experience from pharmaceutical manufacturing operations including outsourcing and CMO management. You hold a Master’s degree in Engineering, Life Sciences, or a related scientific discipline. You have a solid understanding of GMP-regulated manufacturing environments and a proven track record of managing outsourcing programs and external manufacturing partners within the pharmaceutical or biotech industry. Experience from late-stage development, technology transfer and commercial manufacturing is highly valued. Experience from injectable products and combination products is considered a strong merit. As a person, you are structured, collaborative, and communicative, with a proven ability to drive complex projects and build strong relationships across multiple stakeholders. You combine a proactive and results-oriented mindset with a pragmatic and hands-on approach, while maintaining a humble and low-prestige attitude. Fluency in spoken and written and English is required. Camurus offers This a great opportunity to join a highly dynamic company during a very exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market – and the ambitions are not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. You will have great opportunities to influence, and you will work together with highly competent colleagues, caring for each other. Camurus has almost 300 employees with the head office located in Lund. The corporate culture is driven by our core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment. Information and application For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Camurus, please visit: https://www.camurus.com/. We are looking forward to seeing your application!
Camurus is an international, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for improving the lives of patients with severe and chronic diseases. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® technology and its extensive R&D expertise. The R&D pipeline includes products for the treatment of dependence, pain, cancer, and endocrine diseases. Camurus has operations across Europe, the US, and Australia, with headquarters in Lund Sweden. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com and LinkedIn. In this role, you will get the opportunity to work with committed colleagues in a collaborative team, close to both commercialised products and development projects. Camurus is a rapidly growing and innovative company, and you will have a strong impact on the outsourced manufacturing processes throughout the product lifecycle. We are looking for an experienced Senior Process Engineer to join our Manufacturing Operations team. In this role, you will be responsible for leading technology transfer activities for manufacturing processes for injectable pharmaceutical products, from development into manufacturing environments at Contract Manufacturing Organizations (CMOs). You will support products from clinical development through to commercial supply. As Senior Process Engineer, you will act as a subject matter expert in pharmaceutical manufacturing processes, working closely with internal stakeholders and external partners to ensure robust, scalable, and GMP-compliant manufacturing operations. You will report to the Director Manufacturing Operations. Main responsibility Among others, your responsibilities will include: · Lead technology transfers of injectable pharmaceutical products from development into commercial manufacturing at CMOs. · Partner with R&D to ensure that formulation and process development activities support successful scale-up, manufacturability, and long-term process robustness. · Provide technical support for process development, scale-up, validation, and commercial manufacturing activities at CMOs. · Act as technical lead for investigations and troubleshooting of process deviations, OOS results, manufacturing failures, and other complex technical challenges. · Contribute to CMC documentation in support of global regulatory submissions and product lifecycle management. · Ensure that manufacturing processes are executed in accordance with applicable GMP requirements and regulatory expectations. Candidate profile We are looking for a professional with at least 7 years of experience from pharmaceutical manufacturing operations. You hold a Master’s degree in Engineering, Life Sciences, or a related scientific discipline. You have hands-on experience from manufacturing process development, technology transfer, and GMP-regulated pharmaceutical manufacturing, preferably within sterile or injectable products. Experience from fill-finish operations and combination products development is considered a strong merit. As a person, you are collaborative, responsible, and driven by solving problems. You enjoy getting to the bottom of complex technical challenges and you are a pragmatic team player who takes ownership and follows through on commitments. At the same time, you are humble and low-prestige, always willing to support colleagues and contribute wherever needed. You thrive in a dynamic environment where technical expertise, collaboration, and problem-solving go hand in hand. Fluency in spoken and written English is required. Camurus offers This a great opportunity to join a highly dynamic company during a very exciting phase of growth. Camurus has been very successful in bringing pharmaceutical products to the market – and the ambitions are not to be lowered. With a diversified project portfolio in different stages, the commercial potential is considerable. The position offers an international work environment and corporate culture, with the possibility for individual development and growth. You will have great opportunities to influence, and you will work together with highly competent colleagues, caring for each other. Camurus has almost 300 employees with the head office located in Lund. The corporate culture is driven by our core values of innovation, collaboration, ownership, quality, and passion for realizing our patient-centric commitment. Information and application For more information about this job-opening, please contact recruitment consultant Tobias Lorentzon at TOBLOR Consulting, phone: +46 735 11 10 60. You apply for this position through TOBLOR’s career site, https://career.toblor.se/, by uploading your CV and personal letter. For more information about Camurus, please visit: https://www.camurus.com/. We are looking forward to seeing your application!
We are looking for a driven Line Controller / Business Controller with around 5 years of experience to join an international biopharmaceutical company experiencing strong growth. This is a perfect opportunity for a controller who is ready for a natural next step in their career, combining hands-on line controlling with finance business partnering in a complex global organization. We review applications continuously, so do not hesitate to apply today! About the role Our client is looking for a dedicated Line Controller to take on a central and business-facing role within Research, Development and Medical Affairs (RDMA). The organization manages an annual budget of several billion SEK, divided between project activities and the ongoing line organization, comprising approximately 200 employees and 100 cost centers across Europe, the US, and Japan. In this role, you will act as a financial business partner to several functional line leaders, translating business plans into financial realities and creating transparency around performance. This is a dynamic role suited for someone who wants to combine qualified finance business partnering with clear operational line responsibility (budgeting, forecasting, cost center management, and variance analysis) in a global environment. You are offered A natural career step: A role where you get full ownership of your areas and room to grow in a global biopharmaceutical environment. A strong international network: Collaborate closely with global functional leaders, international co-controllers, and an experienced finance team. Strategic and operational variety: A highly varied role where you move seamlessly between forecasting discussions with functional leaders and hands-on Excel analysis, cost center management, and follow-ups Work tasks Your responsibilities will include: Act as a financial business partner to functional leaders and senior stakeholders within RDMA. Develop a thorough understanding of business plans, priorities, resource requirements, and cost drivers. Constructively challenge budget owners' assumptions and plans, helping to identify practical solutions that balance scientific needs with available resources. Drive the four annual planning and forecasting cycles, including the budget process. Coordinate and quality-assure financial input from a large number of cost centers and business areas. Monitor actual performance against budget/forecast and analyze the underlying causes of variances. Identify financial risks and opportunities, explaining their impact on the full-year forecast. Take ownership of relevant month-end and quarter-end close activities (accruals, reallocations, and closing documentation). Collaborate with accounting, Business Controllers, System Controllers, and the wider global finance organization to improve processes and transparency. We are looking for Around 4-6 years of relevant experience in Business Controlling, Line Controlling, or Finance Business Partnering. Experience with budgeting, forecasting, financial planning, and performance management. Have a solid understanding of month-end closing, accruals, and other accounting-related controlling activities. Have strong analytical capabilities and advanced Excel skills. Are fluent in English and have good communication skills in Swedish. It is meritorious if you have Are fluent in Swedish. Experience in the life science pharmaceutical, research, or other knowledge-intensive industries. Experience in R&D controlling. Experience in providing financial support and guidance to teams or organizations working with clinical studies. Experience with large ERP systems, financial reporting tools, or digital/AI-enabled automation in finance. To succeed in the role, your personal skills are: Structured Proactive Driven Communicative team payer Social Our recruitment process This recruitment process is handled by Academic Work and it is our client’s wish that all questions regarding the position is directed to Academic Work. Our selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the next phase. The process includes two tests: one personality test and one cognitive test. The tests are tools to find the right talent for the right position, to enable equality, diversity, and a fair process.
We're looking for a Junior R&D Lab Engineer to join our forward-thinking, dynamic team and help us create game-changing sensor systems for the biopharmaceutical industry. Do you want to be part of a growing company that's shaping new possibilities in the field? Come join us at ArgusEye — a growing company of around 15 people — and be part of our journey! About the role: You'll be part of a small but growing R&D team of six people dedicated to our sensor development. Your primary focus will be the development of new sensor chips and to test new hardware, a role where your ideas and skills will directly influence the future of our technology. This means planning, designing, and executing experiments related to sensor development and characterization, as well as improving existing solutions. You'll get hands-on with manufacturing processes and surface chemistry, using techniques such as HPLC and other analytical methodologies to evaluate sensor performance. You’ll contribute not only to the development of our technology, but also to shaping how we work, build collaborations, and drive our future growth. What you'll do with assistance: Plan, design, and execute experiments related to the development and characterization of new sensor chips. Generate high-quality data to support the development of better data models. Contribute with ideas and concepts for sensor chip design and fabrication. Develop and validate new product prototypes for various applications. Maintain laboratory notebooks and electronic records in line with data quality and integrity standards. Prepare scientific reports, protocols, and presentations for internal and external stakeholders. Perform regular lab maintenance to ensure a clean and safe work environment. Collaborate closely with other team members to successfully integrate sensor chips into our systems. We’re looking for someone who.. ..loves lab work and believes that great technology starts with curiosity and experimentation. You thrive in a collaborative environment and want to be part of a team where innovation happens every day, and where you can help shape both technology and company culture. About you: Hands-on lab experience, including chemical handling, experiments, and use of standard lab equipment in a wet lab, gained through work experience or academic studies, is required Holds relevant Master’s degree in for example Material science, Biomolecular chemistry, or Bio- and Nanomaterials Strong understanding of organic reactions and surface chemistry applied to sensor development Passion for problem-solving, innovation, and scientific exploration Analytical skills and experience in surface characterization and performance evaluation is a plus Why join us? Work on cutting-edge technology with real-world applications. Be part of a supportive, dynamic team where your contributions are valued. Grow your career in an innovative, fast-paced industry. Learn from our customers and attend industry and R&D conferences to grow professionally. Enjoy the freedom to take ownership of your work, supported by a flexible and relaxed environment that values responsibility. Experience a family-like atmosphere filled with collaboration, curiosity, and team activities like music quizzes, bowling and Friday fika. About ArgusEye: ArgusEye is on a mission to revolutionize biopharmaceutical production. Today, developing life-saving medicines is often a slow, complex, and expensive process, putting vital treatments out of reach for many. By providing advanced sensor systems for real-time monitoring of biological processes, we aim to change that. Our technology, built on 40+ years of research at Linköping University, combines nanoplasmonic sensing with fiber optics to deliver real-time data, speeding up medicine development, improving efficiency, and cutting costs. With partnerships among leading pharmaceutical companies and growing demand, we're scaling to make a bigger impact. At ArgusEye, you'll be part of a close-knit team where your ideas and contributions are truly valued. Together, we're making cutting-edge technology accessible to improve lives worldwide. START: Immediately LOCATION: Linköping JOB HOURS: Full-time CONTACT: Senior Recruiter Mikaela Ehk, mikaela.ehk@oddwork.se (contact for questions regarding the position, not applications) LAST APPLICATION DATE: Applications are reviewed on ongoing basis As a leading recruitment and employer branding company we challenge expectations and match talents with the right corporate culture while helping organizations create stronger employer brands. Curious and want to know more? Step into the world of Oddwork by clicking here or find more career opportunities here!
We're looking for a Product Developer to join our forward-thinking, dynamic team and support the development of game-changing sensor systems for the biopharmaceutical industry. Do you want to be part of a growing company of 15 that's shaping new possibilities in the field? Come join us at ArgusEye and be part of our journey! About the role: In this role, you'll design and develop advanced hardware devices that seamlessly integrate with our sensor chips, driving real impact in biopharma applications. From early idea generation to testing prototypes and final delivery, you'll take a leading role in planning, driving, and coordinating our hardware development projects. As part of our development team, you'll work across the entire product development process with a clear focus on project execution – setting direction, ensuring progress, and aligning stakeholders along the way. Your ability to combine hands-on engineering with strong project management skills will be key in bringing ideas to life and delivering reliable, high-performing products. What you'll do: Lead and drive hardware development projects from idea to finished product Solve engineering challenges and develop innovative solutions Design hardware using CAD tools Coordinate work with multidisciplinary teams and subcontractors Build prototypes, conduct tests, verify and validate designs Take an active role in shaping and improving how we run and manage hardware development projects We’re looking for someone who.. ..is driven by the opportunity to contribute to a life-critical industry through the development of advanced hardware solutions. With experience spanning the full development cycle, you’re used to taking ideas from concept to reality – planning, driving, and ensuring progress along the way. You bring a structured approach to development, where you naturally create clarity, keep momentum, and align people around a common goal to deliver high-quality results. About you: A Master's degree in Mechanical Engineering, Industrial Design, Physics, or a related field 3+ years of experience in product development Good knowledge and experience of GD&T (ISO GPS or ASME Y14.5) Skilled in CAD software (e.g., SolidWorks, or Autodesk Inventor) Proven ability to drive projects from A to Z, preferably in a regulated industry (biopharma, medtech, automotive or similar) A strong communicator who can collaborate with both technical and non-technical stakeholders Knowledge of optics, electronics, fluid mechanics, and simulation tools (e.g., COMSOL, ANSYS, Zemax) and quality systems like ISO 9001 or ISO 13485 is a bonus Why join us? Be part of a supportive, dynamic team where your contributions are valued Grow your career in an innovative, fast-paced industry Learn from our customers and attend industry and R&D conferences to grow professionally Enjoy the freedom to take ownership of your work, supported by a flexible and relaxed environment that values responsibility Experience a family-like atmosphere filled with collaboration, curiosity, and team activities like music quizzes, bowling and Friday fika About ArgusEye: ArgusEye is on a mission to revolutionize biopharmaceutical production. Today, developing life-saving medicines is often a slow, complex, and expensive process, putting vital treatments out of reach for many. By providing advanced sensor systems for real-time monitoring and control of bioprocesses, we aim to change that. Our technology, built on 40+ years of research at Linköping University, combines nanoplasmonic sensing with fiber optics to deliver real-time data, speeding up medicine development, improving efficiency, and cutting costs. With partnerships among leading pharmaceutical companies and growing demand, we're scaling to make a bigger impact. At ArgusEye, you'll be part of a close-knit team where your ideas and contributions are truly valued. Together, we're making cutting-edge technology accessible to improve lives worldwide. START: According to agreement LOCATION: Linköping JOB HOURS: Full-time CONTACT: Senior Recruiter Mikaela Ehk, mikaela.ehk@oddwork.se (contact for questions regarding the position, not applications) LAST APPLICATION DATE: Applications are reviewed on an ongoing basis As a leading recruitment and employer branding company we challenge expectations and match talents with the right corporate culture while helping organizations create stronger employer brands. Curious and want to know more? Step into the world of Oddwork by clicking here or find more career opportunities here!
We're looking for a passionate and driven Senior Manufacturing Scientist – Aseptic Processing to join our Manufacturing Science & Technology (MS&T) team in Uppsala and play a critical role in ensuring the robustness, compliance, and continuous improvement of our aseptic manufacturing processes. At Galderma, we're not just offering a job, we're inviting you to be part of something bigger. About the Role You serve as the site's subject matter expert for aseptic manufacturing and contamination control, providing scientific and technical leadership across critical aseptic operations. You work cross-functionally to support routine operations, troubleshoot complex process challenges, lead investigations, and drive continuous improvement. A key part of the role is leading the site's media fill program and contamination control strategy, and ensuring compliance with evolving regulatory expectations, including EU GMP Annex 1 and global health authority requirements. Key Responsibilities Provide scientific oversight and technical expertise across aseptic manufacturing operations, including compounding, filtration, and filling processes. Lead the site's media fill / Aseptic Process Simulation (APS) program: design, execution, evaluation, reporting, and timely CAPA implementation to strengthen sterility assurance. Lead and support the Contamination Control Strategy (CCS) through scientific risk assessments spanning facility design, HVAC, environmental monitoring, cleaning and disinfection, and aseptic practices. Lead complex deviation investigations, root cause analyses, and CAPA activities related to aseptic processes. Design and evaluate smoke studies to verify airflow performance and first-air protection. Act as a trusted SME in audits, inspections, technology transfers, process improvements, and the implementation of new manufacturing technologies. The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week. Your Profile You're a curious, proactive, and scientifically minded professional who enjoys solving complex challenges and driving improvement in highly regulated manufacturing environments. You take ownership naturally, influence stakeholders with confidence, and navigate complexity while keeping compliance and continuous improvement front of mind. Qualifications Bachelor's, Master's, or PhD in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline, with several years of experience in a biopharmaceutical or other highly regulated manufacturing environment. Strong expertise in aseptic processing, contamination control, media fills, and sterility assurance principles within GMP-regulated operations. Experience with EU GMP, Annex 1 requirements, and regulatory expectations for sterile manufacturing. Proven track record leading deviation investigations, root cause analyses, and CAPA implementation. Excellent analytical, problem-solving, and technical writing skills. Strong stakeholder management and collaboration across multiple functions. Ability to independently manage complex projects and drive continuous improvement initiatives. Application If you believe this can be a right career change for you, please send in an application as soon as possible. We are evaluating the application continuously so please do not wait to send in your application. About Galderma Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ, the skin, meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Our site in Uppsala is Galderma's Global Center of Excellence for Aesthetics, home to over 800 professionals working across R&D, manufacturing, clinical development, and commercial functions. Here, cutting-edge science meets world-class manufacturing, creating an environment where innovation moves rapidly from concept to patient impact. As a Senior Manufacturing Scientist – Aseptic Processing, you'll influence critical manufacturing processes, contribute to regulatory excellence, and play a direct role in delivering high-quality products to patients around the world, joining a collaborative and highly skilled team where your expertise is valued and your ideas are heard.
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.