Key skills
Leadership
About this role
Role Overview
- Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in development or commercial products
- Lead the preparation and submission of CMC sections for commercial or new biologics products
- Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and completeness of submissions
- Manage execution of CMC documentation including IND/CTA, original BLA/MAA, or Post Approval Life Cycle
Requirements
- B.S. in a biological science, engineering, or a related field (advanced degree preferred)
- At least ten years of relevant experience including biologics or vaccine Regulatory CMC, or development; manufacturing, testing, or licensure of biological products; or closely related fields
- Proficient in English; additional language skills are a plus
- Must be capable of periodic travel
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days