Senior Scientist

Support regulatory approval of biologics drug substances by authoring Chemistry, Manufacturing, and Controls (CMC) filing content and contribute to CMC project management for monoclonal antibody development.

Responsibilities:

• 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.
• Complete data integrity checks on regulatory documents, including INDs and BLAs, against relevant source documentation in a timely manner.
• Contribute on program acceleration and increased efficiency initiatives.
• Apply technical knowledge to support problem-solving during process development and validation.

• BS or equivalent education in Biology, Biochemistry, Engineering or related discipline and 10+ years of experience in the biopharmaceutical industry, Master's Degree or equivalent education and typically 8 years of experience.
• Demonstrated knowledge of biologics manufacturing processes, including cell culture and purification operations, and knowledge of process development and validation.
• Demonstrated knowledge of Good Documentation Practices (GDP) and technical writing.
• Demonstrated knowledge of scientific and regulatory requirements for biopharmaceutical products.
• High proficiency with Microsoft Word and Excel.