
MoonLake Immunotherapeutics · PT
JOB PURPOSE The Senior Specialist Drug Product and Device (GxP) provides comprehensive support to Technical Operations and perform essential oversight of Good ...
The Senior Specialist Drug Product and Device (GxP) provides comprehensive support to Technical Operations and perform essential
oversight of Good Manufacturing Pratice (GMP) compliance for Drug Product (DP) and Device vendors. They will manage all
Quality-related issues, oversee CAPAs, Change Controls, and handle GMP-related Temperature Excursions and Technical Complaints,
collaborating effectively with the rest of the MoonLake Quality team, the Technical Operations team and consultants (where
necessary).
This role is responsible for the receipt, assessment, investigation, documentation, and closure of technical complaints in
accordance with GxP regulations (including GMP, GCP, and GDP, as applicable). The role ensures that all technical complaints, such
as device issues, temperature excursions, packaging defects, or product quality concerns, are managed in compliance with internal
procedures and regulatory expectations and are appropriately recorded, investigated, trended, and reported within the electronic
Quality Management System (eQMS).
This role supports patient safety, product quality, and regulatory compliance across clinical and commercial activities.
within defined timelines using the eQMS (e.g., Qualio).
classification
escalation when required
requirements.
support timely resolution and Drug Product / Device assembly, labelling and packaging activities, including complaints.
breaches, where applicable.
specific emphasis on quality and compliance requirements
An exciting job opportunity awaits you!
MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals
to join our stellar team.
Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech
environment.
Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare.
Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our
team.
Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills.
Our Core Values
We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:
We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high
quality, always.
We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other.
We unlock value: We aspire to create long-term value for investors and communities.
INTRODUCTION This is a fantastic career opportunity for someone who is looking to work as part of a world leading product development business: * Exploiting your understanding of the Drug Delivery market place especially the product development challenges and opportunities that impact it * Utilizing your consultative selling skills to engage with customers who need the advanced product development services for which Cambridge Consultants is renowned. Over 70% of our business is with repeat customers * Collaborating with our world-class designers, engineers and scientists to define projects that deliver products and services that exceed our customer’s expectations MAIN ROLE You will work with the Head of Drug Delivery as part of the Global Drug Delivery business development team. Your responsibility will be to support the strategy for the business and execute significant sales and client management activities that result in the continued growth of this major sector of our business. TYPE OF WORK Cambridge Consultants specialises in the development of innovative medical devices from concept through prototype manufacture to transfer to production. Projects often include considerable technical challenge. Within healthcare we undertake development projects in the three focus areas of: * Drug Delivery systems * Clinical Diagnostics Instrumentation * Surgical products and medical systems Our work in Drug Delivery embraces multiple device and disease challenges; inhalers, nebulisers, auto-injectors, pens and pumps, both mechanical and electromechanical including connected systems for diseases encompassing chronic, acute and rare. Our customers include the largest global pharmaceutical companies as well as the most innovative start-ups around the world. We combine highly creative lateral thinking with excellent technical skills and broad industry experience to form powerful development teams. Our work ranges from end-to-end medical device developments to providing consulting services for our clients on their technology, strategy or development processes. RESPONSIBILITIES You will be responsible for supporting all aspects of Business Development for our Drug Delivery business. You will: * Develop strong commercial relationships with senior executives in potential client companies * Establish trusted relationship with clients to drive strategic discussions related to their drug delivery device strategy * Close substantial sales in collaboration with project implementation teams * Work with our technical teams to maximize sales conversion * Feed back market information to the technical teams to support continuous improvement of our service offering * Interact with teams across the broad technical base of Cambridge Consultants which includes: Mechanical engineering, Product design and usability, Electronics, Software, Regulatory affairs, Manufacturing technology, Process automation and Life sciences You will also use your strong commercial and technical skills to make a significant contribution to the overall direction of development projects, often working on more than one concurrently. We take pride in our robust and most comprehensive training and on-boarding program for every new candidate that we hire. As a new joiner, you will receive training in project management, strategic selling, and our ISO13485 medical device development process to enhance your success in the role. This position will be based in our Cambridge UK office, however the successful applicant will need to support our clients and business on a global basis spanning the North American, European and South East Asian markets. REQUIREMENTS To meet the demanding requirements of this role you will be able to provide the following: * In depth commercial understanding of the Drug Delivery market place * Compelling consultative selling skills to engage with customers * Significant commercial experience in the medical product sector such as sales experience with a design and development services company, a medical products company or similar * Proven success in developing business in the Drug Delivery sector with substantial contract values * Excellent interpersonal, communication and presentation skills * Relevant engineering knowledge ---------------------------------------------------------------------------------------------------------------------------------- By submitting an application to Cambridge Consultants, you confirm that the information provided in this application, together with any supporting documentation, is true, complete, and accurate to the best of your knowledge and belief. You understand that any false statement, misleading information, or material omission may render you liable to disqualification from the recruitment process, withdrawal of any offer of employment, or dismissal without notice if discovered following appointment. You acknowledge that the organisation reserves the right to verify the information supplied. ----------------------------------------------------------------------------------------------------------------------------------
Every mind is unique. Yet much of the world is still built for what’s considered "normal," leaving too many people behind. At Everway, we change that by creating technology that helps everyone understand and be understood. By understanding and addressing the unique needs of each individual, we're creating a world where differences are recognized and valued. Our careers fit real life. When you join us, you’re not just taking a job. You’re joining a movement to build a more neuroinclusive world. We’re a global community of over 800 employees spanning North America, UK, Europe, Australia, and New Zealand. A career here is purposeful and fast-moving, with clear expectations, modern tools, and the clarity to focus on what matters most. Our people are supported and encouraged to show up as they are, with different ways of thinking welcomed and valued. We pride ourselves on our core values that are embedded within our culture. These are to be curious, have courage, and commit fully. Join us at Everway - together, we can unlock the full potential of every mind. ABOUT THE ROLE As a Senior Marketing Specialist (Demand Generation), you'll develop and deliver integrated demand generation campaigns that support lead generation, pipeline growth, and commercial objectives across the UK business. Working closely with Sales, Marketing Operations, Product, and the wider Marketing team, you'll translate business priorities into effective marketing plans and deliver campaigns across multiple channels. You'll use market insight and campaign performance data to continually optimise activity and improve results. MAIN RESPONSIBILITIES In this role, you will: * Plan, coordinate and deliver integrated multi-channel B2B marketing campaigns that generate qualified leads, support pipeline growth, and contribute to brand awareness, customer engagement, product marketing and customer retention. * Own marketing campaigns from planning through execution, defining objectives, target audiences, success measures and delivery plans while coordinating stakeholders and campaign assets. * Partner with Marketing Operations and Sales to define target audiences, improve lead management processes, optimise lead quality and support effective campaign follow-up. * Plan and deliver webinars, events and other demand generation activities that engage priority audiences and contribute to lead and pipeline objectives. * Coordinate promotional activity for product launches and updates, working with Product and Marketing teams to deliver consistent communications across multiple channels. * Coordinate the creation of campaign content and marketing assets, ensuring they align with campaign objectives and Everway brand standards. * Build and maintain relationships with agencies, media partners, suppliers and customer advocates, identifying opportunities that support marketing objectives. * Monitor campaign performance across the lead and pipeline funnel, analyse results, and recommend improvements to increase effectiveness, conversion and return on investment. * Manage allocated campaign budgets, monitor performance against agreed KPIs, and recommend where activity and investment should be optimised. ESSENTIAL CRITERIA * 3+ years' experience planning and delivering integrated multi-channel B2B demand generation campaigns. * Experience managing marketing campaigns from planning through execution, evaluation and optimisation. * Experience generating and nurturing leads through integrated marketing campaigns across multiple channels. * Commercial awareness, with the ability to connect marketing activity to lead quality, pipeline growth and sales priorities. * Experience collaborating with Sales and Marketing Operations to improve lead management and campaign performance. * Ability to analyse campaign performance data and use insights to make informed recommendations. * Ability to manage multiple projects and priorities while delivering against agreed objectives. * Familiarity with CRM, marketing automation or campaign management platforms, and experience using AI tools to improve campaign planning, reporting or workflow efficiency. DESIRABLE CRITERIA * Degree or equivalent experience in Marketing, Communications, Business or a related field. * Experience planning and delivering webinars, virtual events or customer engagement activities. * Understanding of SaaS or EdTech business models. * Experience working with agencies, media partners or external suppliers. Please submit your application by Wednesday, 12th August 2026. Please note: applications may close early due to high demand, so early submission is encouraged. #everway Join our team and enjoy a competitive salary with bonus opportunities, flexible work schedules, and comprehensive health and wellness benefits. We offer flexible time off plans, career growth through development programs, and a collaborative, innovative culture where your ideas matter. Ready to make an impact? Apply today and be part of a company that invests in your success! We are committed to providing a Drug-Free Workplace for all employees. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. You can view our Recruitment and Selection Policy here. [https://docs.google.com/document/d/1yDxHyVbhh8MK9NnCYdnEAfVSO4rhPCovVbKK8ecxT4U/edit?usp=sharing] Please click the link for our Privacy Notice [https://docs.google.com/document/d/1uAKvHVSRsqZ83CGhM3_3Dc6RPsXwlTdmwdUH7msHkVM/edit?usp=sharing]
Company Profile With over 80 years of innovation, JCB is the world’s largest privately owned manufacturer of construction and agricultural equipment. Operating 23 manufacturing facilities across four continents—including the United States, the United Kingdom, India, and Brazil—JCB produces a diverse portfolio of more than 300 products. These include telescopic handlers, backhoe loaders, excavators, wheel loaders, compact excavators, skid steer loaders, compact track loaders, access aerial work platforms, rough terrain forklifts, and tractors. At the heart of JCB’s success are its people. As a family-owned business, we are accountable to our customers—not shareholders—which gives us the flexibility to focus on long-term innovation and delivering real value. This independence allows us to continuously develop advanced technologies and integrate them into equipment designed to perform in the toughest environments while maximizing customer productivity. At JCB, we stand behind our products—and our name—with pride and commitment to quality. Position Purpose The Sr. Product Specialist – Assembly is responsible for supporting product quality, manufacturability, and continuous improvement throughout the production lifecycle. This role serves as the key liaison between engineering, production, quality, and operations to ensure products meet design intent and operational requirements. The specialist will analyze defects, drive root cause investigations, support process improvements, manage product introductions and implement solutions to reduce defects. Position Type Full Time, Exempt Location Onsite in Pooler, Georgia: 2000 Bamford Blvd Pooler, GA 31322 Benefits and Other Compensation JCB offers a comprehensive benefits package, including medical, dental, and vision insurance; 401 (k) retirement plan; paid time off and paid holidays. Application Process Applications will be accepted through Careers | JCB Careers | JCB Jobs | JCB [https://www.jcb.com/en-US/explore/engage/careers/] or via LinkedIn. The anticipated application window will close on July 16, 2026. Major Tasks, Responsibilities & Key Accountabilities * Act as the manufacturing engineering point of contact for assigned products and processes * Collaborate closely with Design Engineering to understand product design intent and functional requirements * Provide design feedback and recommend changes to improve manufacturability, reduce defects, and optimize production efficiency * Support cross functional teams with understanding and maintaining design intent * Support manufacturing engineering team members with training of the product at a component level * Lead and maintain the change management process for product introductions (PI’s) * Write, revise, and maintain clear and accurate SOPs and work instructions for assembly processes. * Support continuous improvement initiatives to enhance assembly efficiency, quality, and ergonomics. * Participate in root cause analysis and corrective/preventive action (CAPA) activities. * Ensure compliance with safety, quality, and regulatory standards. * Maintain accurate records of process changes, equipment maintenance, and training activities. * Support additional manufacturing tasks as needed to meet production goals * Other duties as assigned Minimum Qualifications * Associate degree or technical certification in Manufacturing, Engineering Technology, or a related field preferred. * 1–3 years of experience in an assembly or manufacturing environment. * Strong technical writing skills with experience creating SOPs or technical documentation. * Familiarity with lean manufacturing and continuous improvement tools (e.g., 5S, Kaizen, Value Stream Mapping). * Ability to read and interpret assembly drawings, schematics, and technical documents. * Proficiency with basic hand tools, measurement instruments, and diagnostic equipment. * Strong communication and collaboration skills. * Basic computer proficiency (e.g., MS Office, document management systems). * Must pass any drug screens, background checks, and any pre-employment tests, which will be conducted in accordance with applicable law. Knowledge, Skills, Abilities & Competencies * Strong problem-solving and analytical skills. * Ability to work in a high-stress environment. * Detail-oriented and able to work independently. * Collaborative approach to resolving issues impacting various groups across the enterprise. * Ability to understand processes (system and non-system), troubleshoot, develop, and recommend solutions. * Enjoy working in a dynamic environment and be a self-motivated team player. * Working knowledge of Microsoft Office products, including Word, Excel, PowerPoint, Teams, and Microsoft Project. Job Conditions * Manufacturing/factory environment. * Subject to noise and temperature changes. Physical Requirements The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: * Must be able to work flexible schedule, including Friday - Sunday 6am -6pm * Must be able to regularly lift and/or move up to 10lbs, frequently and/or move up to 35lbs, and occasionally lift and/or move up to 50lbs. * Must be able to perform continuous, repetitious physical activities. These activities may involve fine movements or large motions. * Must be able to grasp/pinch small items, reach out and up, and turn wrist. * Must be capable of keeping pace with current production speed. * Must be able to push/pull with reasonable force. * Must be able to perform the following requirements of bending, stooping, climbing, kneeling, and standing for extended periods of time. * Must be able to work in multiple climates including hot/cold temperatures, and dusty environment. Equal Opportunity Employer JCB is an equal employment opportunity (EEO) employer in accordance with applicable federal, state, and local laws. JCB complies with applicable state and local laws governing non-discrimination in employment at every location where the company has facilities. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability statute, or any other characteristic protected under federal, state, and local laws. EEO EMPLOYER/VET/DISABLED. Reasonable Accommodation Statement JCB complies with federal and state disability laws and makes reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact the JCB Human Resources team at hrsupport@jcb.com [hrsupport@jcb.com]. JCB Inc. is not currently hiring individuals for this position who now or in the future require sponsorship for employment visa status; however, as a global company, JCB offers many job opportunities outside of the U.S., which can be found through our website at https://www.jcb.com/en-gb/about/careers [https://www.jcb.com/en-gb/about/careers]. Disclaimer: This job description is general in nature and is not designed to contain or to be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to the job.