Senior Scientist, Drug Product Manufacturing and Development

We are seeking a Senior Scientist to support drug product formulation and manufacturing with external partners and CDMOs, with a focus on oral solid dosage forms. The ideal candidate will have a working knowledge of drug product development through all stages of clinical development.

Requirements

• Support technology transfer, formulation, and process development, optimization, scale-up, and manufacturing of clinical supplies
• Collaborate closely with internal cross-functional teams
• Review master batch records and executed batch records to ensure product quality
• Author change controls, review specifications, change notifications, and manage manufacturing deviations
• Present formulation development and manufacturing updates to internal and external stakeholders periodically
• Author, review, and update CMC specific documents to support worldwide regulatory submissions

Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants