Manufacturing Lead

Lexington $90,000 - $100,000 Permanent

Job Responsibilities:

  • Oversee and execute therapeutic manufacturing processes, ensuring compliance with GMP regulations and maintaining the highest standards of quality, safety, and efficiency.
  • Lead efforts to enhance productivity, reduce waste, and minimize downtime through continuous improvement initiatives.
  • Act as the primary contact for Tech Transfer, ensuring smooth process transfer and scale-up from development to commercial production.
  • Work with compliance and documentation teams to provide technical expertise during document revisions.
  • Conduct thorough evaluations, identify areas for improvement, and implement corrective actions as needed.
  • Analyze key process metrics such as yield, cycle time, and equipment utilization to identify trends and drive optimization strategies.
  • Support Supervisors in generating BOMs, requesting materials for non-commercial products, and ensuring efficient use of resources.
  • Act as backup for the monthly meeting lead for Tier 1 meetings and manage the Continuous Improvement board at Tier 1.
  • Serve as the primary contact for Supervisors regarding troubleshooting and issue resolution.
  • Ensure accurate documentation, timely review, and submission to Quality Assurance for forms and logbooks.
  • Ensure staff adherence to all relevant SOPs, BPRs, SLRs, and safety guidelines.
  • Initiate and manage deviations or investigations, working with cross-functional departments to identify root causes.


  • High School Diploma with 10+ years of related industry experience.
  • Bachelor’s or Master’s degree in Life Sciences/Engineering field with 5+ years of GMP manufacturing experience.
  • Prior leadership experience.
  • Experience in a comparable position within an industrial organization.
  • Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures.
  • Hands-on experience in writing and reviewing documentation.
  • Experience in GMP manufacturing operations – USP, DSP, Buffer, and DP.
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