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 process development functions to ensure technical information is accurately transcribed into regulatory documents.
- Complete data integrity checks on regulatory documents (INDs and BLAs) against source documentation in a timely manner.
- Contribute to program acceleration and increased efficiency initiatives.
- Apply technical knowledge to support problem-solving during process development and validation.

Qualifications:
- BS or equivalent in Biology, Biochemistry, Engineering, or related discipline and 10+ years biopharmaceutical industry experience; Master’s degree or equivalent education and typically 8 years.
- Demonstrated knowledge of biologics manufacturing processes (cell culture and purification) and 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.

Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible to participate in long-term incentive programs.