Sr Mgr, CMC Cell Culture Manufacturing
Apply NowCompany: CSG International
Location: South San Francisco, CA 94080
Description:
Senior Manager, CMC - Cell Culture Manufacturing
Remote - PST Time Zone Preferred
An innovative, clinical-stage biotech company is hiring a Senior Manager, CMC - Cell Culture Manufacturing to oversee cell culture operations at CDMO partners supporting investigational antibody therapeutics. This fully remote position (PST preferred) offers the opportunity to make a tangible impact on both clinical development and future commercial scale-up efforts.
Key Responsibilities
Qualifications
Why Apply?
Work with a purpose-driven team focused on advancing transformative antibody therapies. Enjoy the flexibility of a remote role while playing a critical role in shaping CMC strategy and execution.
Remote - PST Time Zone Preferred
An innovative, clinical-stage biotech company is hiring a Senior Manager, CMC - Cell Culture Manufacturing to oversee cell culture operations at CDMO partners supporting investigational antibody therapeutics. This fully remote position (PST preferred) offers the opportunity to make a tangible impact on both clinical development and future commercial scale-up efforts.
Key Responsibilities
- Provide technical oversight for CDMOs manufacturing investigational biologics.
- Evaluate and guide cell culture processes, including parameter specification and optimization.
- Manage change controls, deviations, and CAPAs internally.
- Review batch records, monitor data trends, and assess OOT/OOS results.
- Draft and review protocols, technical reports, and risk assessments.
- Contribute to regulatory filings (BLA/MAA), supporting CMC documentation.
- Collaborate with cross-functional teams and participate in CDMO selection and onboarding.
Qualifications
- Degree in Chemical Engineering, Bioengineering, Biology, Biochemistry, or related field (BS/MS/PhD).
- 8+ years of biopharma experience, including product launch and process validation (PPQ).
- Hands-on CDMO oversight experience in a cGMP environment.
- Strong understanding of FDA and EU regulatory requirements.
- Proven ability to work independently and drive projects forward.
- Effective communicator with strong project management skills.
- Willingness to travel occasionally for onsite meetings and PIP activities.
Why Apply?
Work with a purpose-driven team focused on advancing transformative antibody therapies. Enjoy the flexibility of a remote role while playing a critical role in shaping CMC strategy and execution.