CMC Biologics Quality Assurance Specialist

Lundbeck A/S, H is seeking a highly skilled Quality Assurance Specialist to join its CMC Development team.The successful candidate will be responsible for ensuring the quality and integrity of Investigational Medicinal Products (IMPs) used in clinical trials. This involves reviewing batch records, assessing QA deviations, change controls, and laboratory...

Overview of CMC BiologicsH. Lundbeck A/S is a global pharmaceutical company focused on the development and commercialization of innovative treatments for brain disorders.We are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics team, which supports the development and production of new biologics drug candidates for diseases...

About the RoleWe are seeking a skilled Quality Assurance Specialist to join our team in Emerging Technologies API Manufacturing Development (ET API MDev). As a key member of our organization, you will play a crucial role in ensuring compliance with GxP guidelines and regulations.Key ResponsibilitiesAct as a one-point-of-entry for audits and inspections,...

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. As a Quality Assurance and Control Professional, you will be responsible for ensuring the highest standard of quality in our products. You will work closely with the production team to ensure that...

At AGC Biologics, we value Knowledge, Trust, Quality, Ingenuity, Accountability, and Teamwork as our core values. We believe these values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.We are looking for scientists to support the following main areas:Microbial ProductionMammalian...

About the PositionWe are seeking a highly skilled Senior Quality Control Scientist to join our CMC Biologics Quality Control team.As our Senior Quality Control Scientist, you will be responsible for technical leadership and subject matter expertise in Quality Control activities with a focus on drug-device combination products.You will work closely with...

As a Biologics Production Specialist, you will play a crucial role in the development and manufacturing of biopharmaceutical proteins for clinical studies and commercial markets. Our production team operates on rotating shifts, including days, evenings, nights, weekends, and overtime during peak periods. Flexibility in work hours is essential.About You:Hold...

At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics.We're looking for a Global CMC Director to join our Regulatory Affairs CMC team. As a key member of our team, you will be responsible for operational...

Lundbeck A/S, H is seeking a highly skilled professional to join its team as a QA Academic in the CMC Development department.As a member of our team, you will be responsible for ensuring patient safety and GMP compliance of Investigational Medicinal Products (IMPs) for clinical trials. Your role will involve batch record review, QA assessment of deviations,...

About the RoleWe are seeking a highly skilled and motivated Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the quality of raw materials and packaging materials going into all of Novo Nordisk's marketed products.You will work closely with suppliers located around the world, ensuring that they meet our...

About the JobWe are seeking a highly motivated and experienced Quality Assurance Specialist to join our Supply Chain QA team at Novo Nordisk A/S. As a key member of our team, you will be responsible for ensuring the quality level at our external warehouses operated by external suppliers.Key Responsibilities:Drive the Quality agenda and ensure compliance with...

Job DescriptionIn this role, you will be responsible for:Technical lead and subject matter expert for Quality Control activities with focus on drug-device combination products.Working closely with contract manufacturing organizations (CMOs) to plan, implement, and finalize QC relevant activities.Reviewing and approving protocols, reports, and other documents...

Do you bring Project Management skills from working in a development area? Do you have experience within Biologics and working with CDMOs? Join us from the beginning of a new drug development project and be part of our exciting journey in Global CMC-Development.The positionYou will as CMC Project Manager join Global CMC-Development with approximately 50...

We are seeking a Biologics Maintenance Professional to join our team in Copenhagen, Denmark. In this role, you will be responsible for translating technical insight into operational processes that enhance our daily work.Main Responsibilities:Drive continuous improvement of maintenance routines and systemsCollaborate with teammates to ensure stable...

We are seeking a Senior Regulatory Specialist to join our dynamic Regulatory Affairs CMC team at Genmab A/S.As a Senior Regulatory Specialist, you will be responsible for providing operational and strategic regulatory CMC input to support worldwide development and commercialization.You will work closely with cross-functional teams to ensure compliance with...

About the PositionAt Venaris Executive Search ApS, we are seeking an experienced Quality Assurance Specialist to drive excellence in maintaining and improving quality standards at the forefront of underwater acoustic solutions. As a key member of our team, you will play a central part in shaping the future of advanced subsea technologies for hydrographic,...

Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics.We are seeking a Director/Associate Director to join our Regulatory Affairs CMC team, responsible for providing operational and strategic regulatory CMC input to support worldwide development and...

At Radiometer Danmark, a company within Danaher, we are seeking a Quality Assurance Specialist to join our team. As a crucial role in ensuring compliance within the organization, this position will be onsite and part of the RAQA organization located in Brønshøj.The successful candidate will have the opportunity to work with handling quality management...

Radiobotics is seeking a skilled Medical Device Quality Assurance Specialist to join our Clinical and Regulatory team. As a key member of this team, you will play a central role in maintaining superior product quality and placing our products on new markets.As a QA/RA specialist, you will become the expert in all corners of our Quality Management System. You...