The role involves performing and leading technical reviews of assays for stability, batch release, and method transfer in accordance with GMP principles
Job Summary
The role involves performing and leading technical reviews of assays for stability, batch release, and method transfer in accordance with GMP principles.
Candidates must independently assess assay validity and handle complex scenarios involving Out of Specification (OOS) and Out of Trend (OOT) results.
The position requires collaborating with cross-functional teams to ensure quality outcomes while supporting regulatory and customer audits.
Matching Summary
Match Score: 75
The role involves performing and leading technical reviews of assays for stability, batch release, and method transfer in accordance with GMP principles.
Skills & Requirements
Must-have
Bachelor's or master's degree in biology
Good understanding of protein stability
Working knowledge of cGMP regulations
Strong ability to interpret scientific data
Experience with OOS and OOT investigations
Nice-to-have
Proactive mindset with problem-solving skills
Mentoring and training junior staff members
Leading continuous improvement initiatives
Participating in customer interactions and audits
Key Requirements
Bachelor's or master's degree in biology, Biochemistry, Biotechnology, or related discipline
Working knowledge of cGMP within a regulated environment