Process/Manufacturing Senior Manager, Engineering

Repligen Corporation; California (MO); Hybrid; USD 180,000 - 225,000; Full time

Benefits offered by this job

Bonus program

Equity option

Benefits package

Job summary

Repligen Corporation in Rancho Dominguez, CA, seeks a Senior Manager, Process & Manufacturing Engineering to lead a multidisciplinary team responsible for manufacturing support, process optimization, technology transfer, and capital projects. You will drive safety, quality, and operational excellence to support company growth.

Responsibilities include leading device and process validation, lifecycle management, and audits, collaborating with Operations, Quality, Supply Chain, Facilities, and R&D

Qualifications

• 10+ years of engineering experience with leadership in life sciences, biopharma, or related industries.
• Experience leading manufacturing, process engineering, tech transfer, and capital projects in regulated environments.
• Strong knowledge of ISO and GMP, validation, and change management.

Responsibilities

• Lead, develop, and mentor the Process and Manufacturing Engineering team.
• Provide technical leadership for manufacturing processes, equipment, and systems.
• Drive optimization, troubleshooting, yield improvement, cost reduction, and lifecycle management.
• Lead technology transfers, new product introductions, and process validations.
• Manage capital projects, equipment installations, and capacity expansion from concept to implementation.
• Collaborate with Operations, Quality, Supply Chain, Facilities, and R&D to achieve manufacturing performance goals.

Skills

Leading teams

Strategic thinking

Operational excellence

Stakeholder management

Decision making

Education

Bachelor's degree in Engineering

MS/MBA or equivalent preferred

Job description

## Process/Manufacturing Senior Manager, EngineeringApply: Rancho Dominguez, CA: Full time: Posted 30+ Days Ago: R-437The Senior Manager, Process & Manufacturing Engineering provides strategic and technical leadership for manufacturing engineering, process engineering, technology transfer, and capital project execution at the Rancho Dominguez facility. This role leads a multidisciplinary engineering team responsible for manufacturing support, process optimization, new product introductions, equipment and process validation, and operational excellence initiatives. Working closely with Operations, Quality, Supply Chain, R&D, Facilities, EHS, and the Global Engineering Network, the Senior Manager drives safety, quality, compliance, productivity, and capacity expansion while supporting the company's growth objectives.* Lead, develop, and mentor the Process and Manufacturing Engineering team, fostering a culture of safety, accountability, collaboration, 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, yield improvement, cost reduction, and operational excellence initiatives.* 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 through implementation.* Partner with Operations, Quality, Supply Chain, Facilities, and R&D to support manufacturing performance and strategic business objectives.* Ensure compliance with applicable regulatory, quality, and company standards, including ISO 9001, GMP, validation, and change management requirements.* Serve as the engineering representative during customer audits, regulatory inspections, and quality audits.* Develop and approve engineering documentation including change controls, protocols, risk assessments, investigations, and technical reports.* Utilize data analytics, Lean Manufacturing, Six Sigma, and statistical methods to improve process capability, OEE, quality, and productivity.* Manage departmental budgets, capital plans, staffing, and resource allocation to support business priorities.* Collaborate with the Global Engineering Network to standardize best practices and execute strategic growth initiatives.**Qualifications****Education*** Bachelor's degree in Engineering or a related technical discipline required.* Advanced degree (MS, MBA, or equivalent) preferred.**Experience*** 10+ years of engineering experience including 5 years of leadership within life sciences, biopharmaceutical, medical device, biotechnology, or advanced manufacturing environments.* Proven success leading manufacturing, process engineering, technology transfer, operational excellence, and capital project initiatives within regulated industries.* Experience managing and developing technical teams while driving business performance, operational efficiency, and organizational growth.* Strong understanding of manufacturing operations, quality systems, validation, and regulatory requirements, including ISO and/or GMP environments.* Experience supporting filtration, single-use technologies, medical devices, or related manufacturing processes is preferred.**Leadership & Professional Competencies*** Demonstrated ability to lead high-performing teams and influence across cross-functional and global organizations.* Strategic thinker with strong business acumen and the ability to translate organizational objectives into executable engineering strategies.* Proven track record of driving operational excellence, continuous improvement, and organizational change.* Strong communication, stakeholder management, and decision-making skills, with the ability to effectively engage employees, customers, and senior leadership.* Ability to balance day-to-day operational priorities with long-term growth, capacity, and technology strategies*Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated salary range for this role, based in the United States of America is $180,000-$225,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.*