Senior Biologics Scientist

Job Summary

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