LI
Manufacturing Manager
LanceSoft Inc
- 🇺🇸 United States
- On-site
- Manager or above
- 5 days ago
- GMP
- Shopify Liquid
- CAPA
- calibration
- Lean Six Sigma
5 days ago
Job Title: Manufacturing Manager
Location: Pleasanton, CA (Onsite)
Salary Range: $130K–$160K
Travel: Minimal; occasional vendor or site visits
Job Description:
Establishing a new GMP-aligned manufacturing facility in the U.S. and is seeking a hands-on Manufacturing Manager to build and lead cell culture media production operations from the ground up.
The ideal candidate has direct manufacturing experience with both powder and liquid cell culture media, gained at a cell culture media manufacturer or media production company. The role will oversee media preparation, production scale-up, in-process controls, batch manufacturing, and team leadership while supporting consistent product quality and GMP-compliant operations.
Key Responsibilities
- Lead powder and liquid cell culture media manufacturing, including formulation, preparation, mixing, powder blending, sterile filtration, and dispensing, as applicable.
- Develop and scale manufacturing processes and support technology transfer from R&D to production.
- Establish SOPs, batch manufacturing records (BMRs), and compliant production workflows.
- Monitor in-process controls, manufacturing parameters, batch documentation, and product consistency.
- Collaborate with QA/QC on deviations, investigations, CAPA, change control, and manufacturing quality issues.
- Coordinate production equipment operation, qualification, calibration, and maintenance.
- Build, train, and lead the manufacturing team while improving operational efficiency and right-first-time execution.
Required Qualifications:
- Bachelor's or Master's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or a related field.
- At least 5 years of relevant manufacturing experience.
- Previous experience at a cell culture media manufacturer or media production company.
- Direct, hands-on experience manufacturing both powder and liquid cell culture media is mandatory.
- Experience with media preparation, production scale-up, in-process controls, and batch manufacturing.
- Demonstrated experience leading teams in a manufacturing environment.
- Strong knowledge of GMP manufacturing practices, batch documentation, data integrity principles (ALCOA+), and applicable regulatory expectations.
- Experience supporting manufacturing investigations, deviations, and CAPA.
Preferred Experience
- Experience establishing manufacturing operations in a startup or greenfield facility.
- Experience with technology transfer from R&D to manufacturing and cross-functional collaboration with QA/QC.
- Familiarity with aseptic processing, sterile filtration, single-use technologies, and closed-system processing.
- Exposure to equipment qualification, calibration, maintenance, process optimization, or Lean/Six Sigma practices.
Manufacturing Manager · LanceSoft Inc