GMP Cell Culture Media Manufacturing Lead (Greenfield)

Lancesoft; Pleasanton (CA); On-site; USD 130,000 - 160,000; Full time

Job summary

Lancesoft in Pleasanton, CA, seeks a hands-on Manufacturing Manager to establish and lead a new GMP-aligned cell culture media production facility in the U.S. The role focuses on building operations from the ground up, ensuring quality, and driving scale‑up from R&D to production.

The ideal candidate has direct experience in powder and liquid cell culture media, implements compliant batch documentation, and leads teams in a manufacturing environment, with a strong emphasis on data integrity and

Qualifications

• Bachelor's or master's degree in biotechnology, biochemical/chemical engineering, pharmaceutical sciences or related field
• At least 5 years of relevant manufacturing experience
• Direct hands-on experience manufacturing powder and liquid cell culture media
• Experience with media preparation, scale‑up, in‑process controls, and batch manufacturing

Responsibilities

• Lead powder and liquid cell culture media manufacturing, including formulation, preparation, mixing, powder blending, sterile filtration, and dispensing.
• Develop and scale manufacturing processes and support tech 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.

Skills

Leadership

GMP knowledge

Data integrity (ALCOA+)

Education

Bachelor's or Master's in Biotechnology/related field

Job description

Lancesoft in Pleasanton, CA, seeks a hands-on Manufacturing Manager to establish and lead a new GMP-aligned cell culture media production facility in the U.S. The role focuses on building operations from the ground up, ensuring quality, and driving scale‑up from R&D to production.

The ideal candidate has direct experience in powder and liquid cell culture media, implements compliant batch documentation, and leads teams in a manufacturing environment, with a strong emphasis on data integrity and