Manufacturing Manager

OPM Biosciences; Pleasanton (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

OPM Biosciences is building a new GMP-aligned manufacturing facility in the United States and seeks a Manufacturing / Media Production Manager to lead the cell culture media operations from the ground up.

You will oversee GMP manufacturing execution, process setup, and scale-up, ensuring robust, reproducible, and high-quality output while developing a skilled production team and driving continuous improvement across the site.

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.

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.

Skills

GMP manufacturing

Cell culture media

Process development

Batch documentation

CAPA & deviation management

Technology transfer

QA collaboration

Lean / Six Sigma

Education

Bachelor's or Master's degree in Biotechnology / Biochemical Engineering / Chemical Engineering / Pharmaceutical Sciences

Tools

Aseptic processing

Single-use technologies

Closed-system processing

Job description

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 to Manufacturing to 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.