Related skills
process development process validation scale-up cgmp tech transfer📋 Description
- Oversee drug product manufacturing at CMOs (formulation, aseptic filling, packaging)
- Lead studies: filter validation, E&L, compatibility, shipping
- Review master and executed batch records for release
- Support tech transfer and oversee DP unit operation transfers
- Provide technical support for formulation development
- Ensure processes are cGMP compliant and meet regulatory requirements
🎯 Requirements
- BS/MS in Pharmaceutical/Chemical Eng or related field; 5-10 yrs Biopharma/Pharma/Biotech
- Biologics DP manufacturing and development incl tech transfer, scale-up
- Aseptic filling of liquid vials, pre-filled syringes, and DP devices
- cGMP regulations, process validation, and aseptic processing
- FDA, EU, and ICH guidelines knowledge
- Strong decision-making, leadership, and interpersonal skills; travel ~25%
🎁 Benefits
- Total rewards program including bonus and equity
- Invivyd is an equal opportunity employer
- Learn more about total rewards at invivyd.com/careers
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