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.