Senior Scientist, II CMC Sciences Biologics Development and Launch (BDL)

Support regulatory approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls (CMC) filing content and by leading cross-functional CMC teams throughout Phase 1, Phase 2, and Phase 3 development. Author sections of regulatory documents, including INDs and BLAs, based on relevant source documentation. Partner with subject matter experts in various process development functions to ensure technical information is accurately transcribed into regulatory documents. Lead CMC teams in the development of robust control strategies and presentation of Control Strategy Reviews (CSRs). Drive alignment with key business stakeholders including Product Development Directors, Development Sciences, and Quality Assurance and escalate issues to senior management when appropriate Contribute on program acceleration and increased efficiency initiatives. Demonstrated knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development. Demonstrated knowledge of Good Documentation Practices (GDP) and technical writing. Demonstrated knowledge of scientific and regulatory requirements for biopharmaceutical products.