Position Details
About this role
This role involves leading biologics cell culture process development and commercialization efforts, supporting regulatory filings, and collaborating across global teams to bring biologic medicines to market.
Key Responsibilities
- Develop cell culture strategies
- Support process characterization
- Lead tech transfer activities
- Prepare regulatory filings (IND, BLA)
- Collaborate with cross-functional teams
Technical Overview
Focus on mammalian cell culture, process characterization, tech transfer, and regulatory compliance within biologics manufacturing, supporting FDA, EMA, JNDA, and TGA filings.
Ideal Candidate
The ideal candidate is a mid-level biologics scientist with extensive experience in cell culture development, process characterization, and regulatory filings such as IND and BLA. They possess strong leadership skills and can collaborate across global teams to support biologics commercialization.
Must-Have Skills
Nice-to-Have Skills
Tools & Platforms
Required Skills
Hard Skills
Soft Skills
Industry & Role
Keywords for Your Resume
Deal Breakers
Lack of experience in biologics process development, No regulatory filings experience (IND, BLA), No leadership or team management experience, Location outside USA or no willingness to relocate
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