Senior Scientist, Chemistry, Manufacturing & Controls

CMC Specialist – GMP Biologics Manufacturing Expertise

This role directs, supervises, and oversees GMP manufacturing of biologics drug products (including ADCs) to support clinical development. A candidate must have strong knowledge and experience of CMC requirements and compliance aspects for biologics, including process development (upstream and downstream, cell culture, purification), manufacturing and testing methodologies, and documentation (specifications, batch records, etc.). Familiarity with ICH guidelines and FDA/HSA regulations to ensure compliance with global manufacturing standards is necessary. Prior experience in preparation and review of CMC dossiers for submission to US FDA, HSA and other health authorities is essential.

Requirements

• Advanced degree in life sciences, biotechnology, pharmaceutical sciences, or chemical engineering.
• 8–10 years of experience in a GMP manufacturing environment.
• Prior experience ou...