Manufacturing Manager

OPM Biosciences; Pleasanton (CA); Vor Ort; USD 140.000 - 210.000; Vollzeit

Zusammenfassung

OPM Biosciences is seeking a highly experienced manufacturing leader to head GMP operations for cell culture media in Pleasanton, CA. The role focuses on aseptic processing, batch documentation, and compliance with ALCOA+ data integrity principles.

You will drive technology transfer from R&D to manufacturing, lead continuous improvement initiatives, and develop a skilled production team to meet quality and regulatory standards in a fast-paced biopharma environment.

Qualifikationen

• Degree in Biotechnology, Biochemical/ Chemical Engineering, Pharmaceutical Sciences, or related field.
• 5–10+ years of GMP manufacturing or biopharma production experience.
• Aseptic processing or media formulation experience at production scale.
• Strong knowledge of GMP systems, batch documentation, and regulatory expectations (FDA/EMA preferred).

Aufgaben

• Lead GMP manufacturing operations for cell culture media, including mixing, formulation, sterile filtration, and dispensing.
• Develop and execute SOPs, BMRs, and GMP production workflows.
• Support technology transfer from R&D to manufacturing and scale-up.
• Ensure compliance with GMP requirements, batch documentation standards, and ALCOA+ data integrity.
• Manage deviations, CAPA, and change control with QA/QC.
• Oversee production equipment operation, qualification, and maintenance support.
• Build, train, and develop the production team while driving operational excellence.

Kenntnisse

GMP manufacturing

Aseptic processing

Batch documentation

Data integrity(ALCOA+)

Team leadership

Ausbildung

Biotechnology/Engineering degree

Jobbeschreibung

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)

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
• 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.