Related skills
process development gmp cell culture cdmo tech transfer📋 Description
- Guide protein production process from lab to GMP CDMO manufacturing.
- Analyze process/mfg data to optimize performance.
- Troubleshoot processes; identify root causes; resolve deviations.
- Review/approve batch records; assist investigations.
- Develop process characterization and validation strategies/docs.
- Support regulatory activities including submissions and site inspections.
🎯 Requirements
- PhD in biology/chemistry/biochemistry/engineering or related field.
- 10+ years biologics development/manufacturing experience.
- Significant experience with cGMPs.
- Proven track record advancing assets from preclinical to IND/late phase.
- Experience in commercialization of biologics and regulatory expectations.
- Substantial tech transfer leadership to CDMOs and campaigns.
🎁 Benefits
- Salary range: $215,000-$230,000.
- Culture built on Apogee CORE values.
- Fast-paced environment with growth opportunities.
- Competitive compensation: base, bonus, equity, benefits.
- Paid time off and company-wide shutdowns.
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