Manufacturing Manager

Manufacturing Manager

Location Pleasanton, CA - Department Operations - Reports to President, US Site / Operations Leadership - Employment type Full-time

Work model On-site - Travel Minimal; occasional vendor / site visits - Function Startup biotech / media production - Last updated June 2026

Position Summary

OPM Biosciences 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.