Position Details
About this role
This role involves leading biologics process development, scale-up, transfer, and validation activities for late-stage and commercial drug products, ensuring regulatory compliance and manufacturing success.
Key Responsibilities
- Lead process scale-up
- Manage technology transfer
- Conduct process validation
- Prepare regulatory submissions
- Support manufacturing investigations
Technical Overview
Focus on biologics, sterile drug process validation, technology transfer, and regulatory submissions within a biotech/pharmaceutical environment.
Ideal Candidate
The ideal candidate is an experienced scientist with expertise in biologics and sterile drug products, with a strong background in process scale-up, transfer, validation, and regulatory submissions. They should have leadership skills and experience supporting late-stage manufacturing and process development.
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 biologics experience, No process validation or transfer experience, Inability to support regulatory submissions, No leadership or mentorship background
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