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Senior Stability Scientist
2 months ago
We are seeking a highly skilled Senior Stability Scientist to join our Quality Control team at AGC Biologics in Copenhagen.
About the RoleThis is a senior-level position that requires a strong background in stability studies, quality control, and analytical techniques. The successful candidate will work closely with cross-functional teams to ensure the stability of drug substances, drug products, placebos, and reference materials.
Main Responsibilities- Develop and implement stability protocols and reports for customer projects
- Collaborate with customers on stability-related topics and ensure cGMP compliance with EU and FDA guidelines
- Oversee testing at external laboratories and manage analytical stability packages
- Write and review critical documents, including CRs, deviations, and CAPAs
To be successful in this role, you will need:
- A Master's degree in Biochemistry, Pharmaceutical Sciences, or a related field
- Significant experience in quality control or quality assurance, preferably with a focus on stability studies
- Strong knowledge of chromatographic and bioassay methods
- Excellent communication skills in English, both written and verbal
- A proven track record of driving continuous improvement and productivity programs
- The ability to work independently and as part of a team
We offer a competitive salary, benefits package, and opportunities for professional growth and development. Our company culture values teamwork, innovation, and a commitment to excellence.
SalaryThe estimated salary for this role is around 120,000 DKK per annum, depending on experience and qualifications.