Related skills
gmp cdmo purification protein qbd📋 Description
- Lead purification process development from lab to GMP manufacturing.
- Manage CDMO relationships to enable robust DS/DP production for protein biologics.
- Provide technical leadership in purification and scale-up from lab to manufacturing.
- Support manufacturing campaigns including tech transfer, deviations, and campaign analysis.
- Advance clinical assets through development including second-gen processes and late-phase development.
- Collaborate with Regulatory on IND/IMPD/BLA submissions.
🎯 Requirements
- PhD in biology/chemistry/biochem or equivalent experience.
- 10+ years biologics development and manufacturing.
- Significant experience with cGMPs.
- Track record advancing assets from preclinical to IND/late-phase.
- Leading tech transfer to CDMOs and supporting campaigns.
- Excellent cross-functional collaboration and communication; travel up to 25%.
🎁 Benefits
- Salary range $215k-$230k, final DOE.
- Equity grant opportunities.
- Health, welfare and retirement benefits.
- Three weeks PTO and two annual company-wide shutdowns.
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