Validation SME Lead

6 days ago


Copenhagen, Copenhagen, Denmark AGC Biologics Full time

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. Our mission is to bring life-changing therapies for patients around the globe.

We are currently seeking a highly motivated and experienced Validation SME Lead to join our team in QC Chemistry. As a key member of our department, you will be responsible for driving PhI/II and PhIII/Commercial method validation activities, reviewing release and stability analytical set-ups, supporting lab technicians, authoring SOPs, and running Lab Investigations, Deviations/CAPAs, and CR cases.

To succeed in this role, you will need to have expertise and ability to troubleshoot on chromatographic methods, especially (U)HPLC, iCIEF, and CGE-SDS. You will also be required to participate in method relevant Customer meetings and provide input for validation plannings, which requires excellent communication skills.

The ideal candidate holds a MSc or PhD degree in Biochemistry, Chemistry, or other relevant area and has +3 years of work experience in QC or analytical development. Candidates with experience from PhIII Validations will have an added advantage. Fluency in written and spoken English is a requirement, since English is our company language.

We offer a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extent be able to plan your daily work yourself.



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