Position Details
About this role
This role involves leading cell culture process development and commercialization efforts for biologics, supporting regulatory filings, tech transfer, and process validation to advance late-stage pipeline products.
Key Responsibilities
- Lead cell culture process development
- Manage regulatory filings
- Oversee tech transfer
- Conduct process characterization
- Support process validation
Technical Overview
The position requires expertise in mammalian cell culture, biologics process development, regulatory submissions (BLA, IND), and process validation within a biotech or pharmaceutical setting.
Ideal Candidate
The ideal candidate is a biologics development leader with expertise in cell culture, process development, and regulatory filings such as BLA, IND, and FDA submissions. They should have experience managing cross-functional teams and leading process transfer and validation activities.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Certifications
Preferred
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of biologics or cell culture experience, No familiarity with regulatory filings (BLA, IND)
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