Senior Bioprocess Engineer Mammalian Cell Culture

• Role: Senior Bioprocess Engineer – Mammalian Cell Culture
• Location: On-site
• Payout: Competitive, based on experience
• Employment type: Full time

Role Overview:

This contractual position requires a Senior Process Engineer specializing in mammalian manufacturing to design, optimize, and maintain biopharmaceutical production processes. The role directly impacts the development of life-saving therapies by ensuring scalable, compliant manufacturing of protein-based pharmaceuticals. Candidates must have proven experience in mammalian cell culture systems and process engineering within regulated environments.

Key Responsibilities:

• Lead process development and characterization for mammalian cell culture systems, including upstream and downstream operations.

• Design and execute experimental plans to optimize yield, viability, and product quality in bioreactor systems.

• Troubleshoot deviations in manufacturing processes and implement corrective actions in alignment with cGMP standards.

• Collaborate with cross-functional teams to transfer processes from development to commercial manufacturing.

• Prepare and maintain technical documentation, including batch records, SOPs, and validation protocols.

Required Skills & Qualifications:

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or a related field; advanced degree preferred.

• Minimum 8 years of experience in mammalian cell culture process development or manufacturing within the biopharmaceutical industry.

• Hands-on expertise with bioreactor operation, scale-up, and process analytics (e.g., DOE, PAT, QbD).

• Proficiency in cGMP regulations, ICH guidelines, and FDA/EMA compliance requirements.

• Strong data analysis skills using statistical tools (e.g., JMP, Minitab) and experience with process modeling software.

More About the Opportunity:

This role contributes to the production of biologics for global clinical and commercial supply. The scope includes continuous improvement of manufacturing efficiency and alignment with regulatory expectations for patient safety. Contract duration is project-based with potential for extension based on performance and program needs.

Equal Opportunity Employer:

We hire based on skills and expertise. All qualified candidates are welcome regardless of background, experience, or prior employment history. Applications are reviewed solely on demonstrated technical ability and qualifications.

Apply now!