Senior Manager, CMC Cell Culture Manufacturing

Meet Life Sciences; United States; On-site; USD 150,000 - 180,000; Full time

Job summary

An established industry player in biotechnology is seeking a Senior Manager for CMC Cell Culture Manufacturing. This pivotal role involves overseeing cell culture manufacturing activities at external partners, ensuring compliance with regulatory standards, and fostering relationships with CDMO partners. The ideal candidate will possess extensive experience in process development and tech transfer, coupled with excellent communication skills to drive cross-functional collaboration. Join a forward-thinking company dedicated to advancing antibody therapeutics and make a significant impact in the biopharma landscape.

Qualifications

• 8+ years in biopharma with hands-on process development experience.
• Strong knowledge of cGMP and regulatory expectations.

Responsibilities

• Lead technical oversight of cell culture manufacturing at CDMOs.
• Collaborate with internal teams for regulatory filings.

Skills

Process Development

Tech Transfer

Regulatory Submissions

Cross-Functional Collaboration

Project Management

Education

BS in Chemical Engineering

MS in Bioengineering

PhD in Biochemistry

Tools

cGMP Standards

Regulatory Guidelines (FDA, EMA)

Job description

Senior Manager, CMC Cell Culture Manufacturing

Senior Manager, CMC Cell Culture Manufacturing

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This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$150,000.00/yr - $180,000.00/yr

Additional compensation types

Annual Bonus and Stock options

Direct message the job poster from Meet Life Sciences

A clinical-stage biotech company focused on advancing antibody therapeutics is seeking a Senior Manager, CMC – Cell Culture Manufacturing. This key role will provide technical and operational oversight of cell culture manufacturing activities at external CDMOs, supporting the development and GMP production of investigational biologics. The ideal candidate will bring deep expertise in upstream process development and manufacturing, combined with strong communication and cross-functional collaboration skills.

Key Responsibilities

• Serve as the technical lead for cell culture manufacturing at CDMOs, providing guidance and oversight across clinical and commercial programs
• Foster and maintain productive relationships with CDMO partners, acting as a hands-on technical advisor and problem solver
• Evaluate and monitor process parameters, specifications, and critical quality attributes
• Lead or contribute to change control, deviation investigations, and CAPA implementation
• Review and trend batch data; assess and address OOT/OOS results
• Oversee batch documentation and release-related activities
• Author and review technical protocols, reports, risk assessments, and tech transfer documents
• Support regulatory filings by preparing or reviewing relevant CMC documentation
• Contribute to CDMO selection and ongoing performance evaluation
• Collaborate cross-functionally with internal stakeholders in CMC, Regulatory, Quality, and Program Management

Qualifications

• BS, MS, or PhD in Chemical Engineering, Bioengineering, Biology, Biochemistry, or related discipline
• 8+ years of experience in the biopharma industry, including hands-on work in process development, tech transfer, and clinical/commercial manufacturing
• Experience leading process transfers and validation (e.g., PPQ) for mammalian cell culture-based biologics
• Strong knowledge of cGMP and global regulatory expectations (FDA, EMA, etc.)
• Proven track record supporting regulatory submissions (e.g., IND, BLA, MAA)
• Skilled in managing CDMOs and working in cross-functional, fast-paced environments
• Excellent organizational, communication, and project management skills
• Willingness to travel for CDMO oversight and in-person meetings as needed

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing, Science, and Research

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Staffing and Recruiting

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