Sr Mgr, CMC Cell Culture Manufacturing

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

• 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.