Senior Scientist, II CMC Sciences Biologics Development and Launch (BDL) -Remote Role
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Boston, MA, US
Company:
AbbVie is a biopharmaceutical company focused on discovering innovative medicines for serious health issues, particularly in immunology and oncology.
Summary:
The Senior Scientist will support regulatory approvals by creating CMC filing content and leading CMC teams in product development. The role requires a background in biology or engineering with substantial industry experience.
Requirements:
Technology: Microsoft Word, Microsoft Excel
Hard Skills: Biologics manufacturing processes, Cell culture and purification operations, Technical writing, Good Documentation Practices (GDP), Scientific and regulatory requirements
Credentials: BS or equivalent education in Biology, Biochemistry, Engineering or related discipline, MS and 6+ years experience, PhD and 3+ years experience
Experience: 8+ years of experience in the biopharmaceutical industry, 6+ years experience with MS, 3+ years experience with PhD
Job Description:
Purpose:
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.
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.
- 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.
