Process/Manufacturing Senior Manager, Engineering

Responsibilities

• Lead, develop, and mentor the Process and Manufacturing Engineering team to foster a culture of safety and continuous improvement.
• Provide technical leadership for manufacturing processes, equipment, and systems supporting filtration and single-use product manufacturing.
• Drive manufacturing performance through process optimization, troubleshooting, root cause analysis, and yield improvement.
• Lead the implementation of new products, technology transfers, process validations, and lifecycle management activities.
• Manage capital projects, equipment installations, facility modifications, and capacity expansion initiatives from concept to implementation.
• Ensure compliance with regulatory and quality standards, including ISO 9001 and GMP requirements.
• Partner with cross-functional teams including Operations, Quality, Supply Chain, and R&D to support strategic business objectives.
• Manage departmental budgets, capital plans, staffing, and resource allocation.

Requirements

• Bachelor's degree in Engineering or a related technical discipline.
• 10+ years of engineering experience.
• 5+ years of leadership experience within life sciences, biopharmaceutical, medical device, or biotechnology environments.
• Proven experience in regulated industries (ISO/GMP).
• Strong knowledge of technology transfer and capital project management.
• Demonstrated ability to lead high-performing teams and influence cross-functional organizations.

Preferred Qualifications

• Advanced degree (MS, MBA, or equivalent).
• Experience supporting filtration, single-use technologies, or medical device manufacturing processes.
• Proficiency in Lean Manufacturing, Six Sigma, and statistical methods.

About the Company

Repligen is a leader in bioprocessing, dedicated to inspiring advances in the production of biologic drugs that improve human health worldwide. We deliver innovative technologies and solutions that help set new standards in bioprocessing efficiency and cost-effectiveness.