Job Description
Position Summary
Key Responsibilities
Qualifications
Preferred Experience
Equal Opportunity Employer
Note
- Client is establishing a new GMP-aligned manufacturing facility in the U.S. We are seeking a Manufacturing / Media Production Manager to build and lead cell culture media manufacturing operations from the ground up.
- This role is responsible for GMP-compliant manufacturing execution, process setup, and scale-up of cell culture media production, ensuring robust, reproducible, and high-quality output.
Key Responsibilities
- Lead GMP manufacturing operations for cell culture media, including mixing, formulation, sterile filtration, and dispensing
- Develop and execute SOPs, batch manufacturing records (BMRs), and GMP production workflows
- Support technology transfer from R&D to manufacturing and scale-up activities
- Ensure compliance with GMP requirements, batch documentation standards, and data integrity principles (ALCOA+)
- Manage deviations, CAPA, and change control processes in collaboration with QA/QC
- Oversee production equipment operation, qualification, and maintenance support
- Build, train, and develop the production team while driving operational excellence initiatives
Qualifications
- Bachelor s or Master s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or related field
- 5 10+ years of experience in GMP manufacturing, biopharmaceutical production, or cell culture media manufacturing
- Hands-on experience in aseptic processing, sterile filtration, or media formulation at production scale
- Strong knowledge of GMP systems, batch documentation, and regulatory expectations (FDA/EMA preferred)
- Proven experience in deviation investigation and CAPA execution
Preferred Experience
- Experience in greenfield GMP facility startup or major facility expansion
- Background in cell culture media, upstream bioprocessing, or biopharma raw material manufacturing
- Familiarity with single-use technologies and closed-system processing
- Experience in cross-functional tech transfer (R&D Manufacturing QA)
- Lean / Six Sigma certification is a plus
- Working Conditions / Physical Requirements
- Ability to stand, walk, and move materials throughout warehouse and laboratory support areas on a daily basis
- Ability to occasionally lift up to 35 lbs
- Ability to support early or late manufacturing schedules when required
Equal Opportunity Employer
- We are an Equal Opportunity Employer.
- All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable law.
Note
- This job description is intended to describe the general scope of the role.
- Responsibilities may evolve as the Pleasanton site ramps and organizational needs change.
Numbers & Facts
| Location | Pleasanton, CA |
| Industry | Staffing/Employment Agencies |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Asepsisunmatched
- Biochemistryunmatched
- Biotech and Pharmaceuticalunmatched
- Cell Culturesunmatched
- Change Controlunmatched
- Chemical Engineeringunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Data Qualityunmatched
- Documentationunmatched
- Documentation Standardsunmatched
- FDA Requirementsunmatched
- GMP (Good Manufacturing Practices)unmatched
- Lean Six Sigmaunmatched
- Lift/Move 35 Poundsunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Operationsunmatched
- Manufacturing/Industrial Processesunmatched
- Material Movingunmatched
- Media Productionunmatched
- Physical Demandsunmatched
- Production Controlunmatched
- Production Managementunmatched
- Production Scheduleunmatched
- Quality Assuranceunmatched
- Quality Assurance Methodologyunmatched
- Quality Controlunmatched
- Regulatory Complianceunmatched
- Research & Development (R&D)unmatched
- Six Sigma Certificationunmatched
- Standard Operating Procedures (SOP)unmatched
- Startupunmatched
- Technical Supportunmatched
- Warehousingunmatched
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