Quality Assurance Manager for Cell Banks and Drug Products
3 days ago
Job Description
The Senior Quality Control Scientist will be responsible for leading Quality Control activities for biologics development, working closely with CMOs, and collaborating with cross-functional teams. This role requires strong leadership skills, technical expertise, and excellent communication abilities.
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
Required Skills and Qualifications
- Minimum 5 years of experience in the biotech or pharmaceutical industry
- Accredited bachelor's degree in Pharmaceutical Sciences, Biochemistry, Analytical Chemistry, Protein Chemistry, Biology, or equal
- Experience in drug-device combination products
- Good understanding of GDP/GMP guidelines
- Knowledge of the United States Pharmacopoeia and the European Pharmacopoeia
- Understanding of methods used to test biological molecules
- Advanced English verbal and written communication skills
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