The Extrusion Manufacturing Lead plays a critical role in the success of Repligen’s extrusion operations. This position provides day-to-day leadership and hands-on technical expertise to extrusion production teams, ensuring safety, quality, delivery, and efficiency standards are consistently met or exceeded. The Lead serves as the primary on-shift point of contact between extrusion operators, maintenance, quality, engineering, and supervision, driving accountability, productivity, and continuous improvement. This role requires advanced extrusion process knowledge, strong troubleshooting capability, and proven leadership skills to coach, train, and develop a high-performing manufacturing team.

Second shift Operators receive a +$1.00 shift differential in addition to their hourly base pay for working this shift

Second Shift Schedule: Monday- Friday 2:00pm-10:30pm

Make a global impact—join Repligen.

We’re united by a mission to inspire advances in bioprocessing as a preferred partner in the production of biologic drugs that improve human health worldwide. No matter your role or background, at Repligen, you will play a key part in shaping some of the most innovative and life-changing therapies in the world. We foster a culture of purpose, collaboration, and shared success—where every voice matters and every contribution drives progress. Join us!

• Lead and oversee daily extrusion production activities to meet or exceed safety, quality, delivery, and productivity goals.
• Provide functional leadership, guidance, and direction to extrusion operators in alignment with production schedules and business priorities.
• Serve as the on-shift subject matter expert for extrusion operations, supporting technical troubleshooting, process deviations, and equipment-related issues.
• Operate and ensure proper setup, changeover, and operation of all extrusion-related production and inspection equipment.
• Monitor production performance, material utilization, and yields; identify bottlenecks or quality concerns and drive corrective actions in collaboration with Quality and Engineering teams.
• Effectively utilize, track, and communicate material usage to support inventory accuracy and production efficiency.
• Assign, coordinate, and track daily work assignments to ensure appropriate resource allocation and timely completion of production orders.
• Lead shift handovers and ensure clear, accurate communication across shifts to maintain continuity and alignment.
• Conduct routine process and housekeeping audits to ensure compliance with SOPs, GMP requirements, cleanroom protocols, and documentation standards.
• Support preventive maintenance activities and ensure all equipment issues are reported, escalated, and resolved promptly.
• Proactively identify and implement process improvement initiatives to enhance efficiency, reduce waste, and improve product quality.
• Train, coach, and cross-train team members on all aspects of extrusion manufacturing processes, equipment operation, tooling, and safety procedures.
• Ensure employees maintain required training and competency levels in accordance with departmental and Quality Management System requirements.
• Communicate safety incidents, quality events, and production issues to the Extrusion Supervisor or Area Manager in a timely manner.
• Uphold and enforce all company policies, including newly implemented or revised procedures.
• Act as the acting lead in the absence of the Extrusion Lead or Supervisor, as needed.

*When and if there are times that extrusion is down due to maintenance or product delays, The lead and all extrusion operators will be required to work within other areas of MFG and/or warehouse to support and keep production flowing.* 

Education:

• High School Diploma or equivalent required; associate degree, technical certification, or college coursework preferred.

Experience:

• Minimum of 3–5 years of experience in extrusion manufacturing or a related regulated manufacturing environment.
• At least 2 years in a senior operator or lead-level role preferred.
• Internal candidates must have met all requirements of Extrusion Operator II for consideration into a Senior or Lead-level role.

Technical Skills:

• Strong understanding of extrusion processes, equipment, materials, and inspection methods.
• Proven ability to troubleshoot extrusion process issues and support root cause analysis.
• Familiarity with thermoplastic materials and process parameters.
• Ability to read and interpret work instructions, specifications, and quality documentation.
• Working knowledge of GMP, cleanroom manufacturing, and quality system requirements.
• Proficiency in Microsoft Office (Excel, Word, Outlook) and ERP systems such as SAP preferred.

Leadership Competencies:

• Demonstrated ability to lead, coach, and motivate production teams.
• Strong organizational, communication, and decision-making skills.
• Ability to hold team members accountable while fostering a positive, collaborative work environment.
• Capable of managing multiple priorities and adapting to changing production demands.

Additional Requirements:

• Comfortable working in a cleanroom environment and wearing required PPE.
• Strong commitment to safety, quality, compliance, and continuous improvement.

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 hourly rate/salary range for this role, based in the United States of America is $26/Hr. -$32/Hr. 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.