Senior Biologics Scientist

A company is looking for a Senior Scientist, II CMC Sciences Biologics Development and Launch (BDL) - Remote Role. Key Responsibilities Author sections of regulatory documents, including INDs and BLAs, based on relevant source documentation Lead CMC teams in developing robust control strategies and presenting Control Strategy Reviews (CSRs) Drive alignment with key business stakeholders and escalate issues to senior management when appropriate Required Qualifications BS in Biology, Biochemistry, Engineering, or related discipline with 8+ years of experience; MS with 6+ years; or PhD with 3+ years Knowledge of biologics manufacturing processes, including cell culture and purification operations Familiarity with Good Documentation Practices (GDP) and technical writing Understanding of scientific and regulatory requirements for biopharmaceutical products High proficiency with Microsoft Word and Excel

Apr 18, 2025 - 19:58

A company is looking for a Senior Scientist, II CMC Sciences Biologics Development and Launch (BDL) - Remote Role. Key Responsibilities Author sections of regulatory documents, including INDs and BLAs, based on relevant source documentation Lead CMC teams in developing robust control strategies and presenting Control Strategy Reviews (CSRs) Drive alignment with key business stakeholders and escalate issues to senior management when appropriate Required Qualifications BS in Biology, Biochemistry, Engineering, or related discipline with 8+ years of experience; MS with 6+ years; or PhD with 3+ years Knowledge of biologics manufacturing processes, including cell culture and purification operations Familiarity with Good Documentation Practices (GDP) and technical writing Understanding of scientific and regulatory requirements for biopharmaceutical products High proficiency with Microsoft Word and Excel