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Senior QC Expert in Biopharmaceuticals
1 week ago
Biologics Quality Control Expertise
The ideal candidate will have minimum 5 years of experience in the biotech or pharmaceutical industry, including experience in drug-device combination products. They will also have a good understanding of GDP/GMP guidelines and knowledge of the United States Pharmacopoeia and the European Pharmacopoeia.
Your New Role
As our Senior Quality Control Scientist, you will be responsible for leading Quality Control activities for biologics development, working closely with CMOs, and collaborating with cross-functional teams. Your expertise will ensure the quality of our biologics drug candidates.
Key Responsibilities
- Lead Quality Control activities for biologics development, focusing on drug-device combination products
- Collaborate with contract manufacturing organizations (CMOs) for planning, implementation, and finalization of QC relevant activities
- Review and approve protocols, reports, and other documents for studies performed internally and at contract laboratories
- Cross-functional collaboration with Process Development, Analytical Development, Quality Assurance, and Regulatory Affairs teams
- Support regulatory filings and interactions with Health Authorities
