harbaheadercoverblack.png

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.

Qualifications:

  • 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.
Share this job:

Apply now

Similar Jobs

Manufacturing Associate

Cambridge 24 - 30 p/h Permanent

Job Responsibilities: Execute manufacturing procedures in an ISO Class 7 clean room, adhering to SOPs, cGMPs, and safety regulations. Perform...

Formulation Chemist

Indianapolis 70K - 105K Permanent

Key Responsibilities: Designing and executing synthetic routes for the preparation of target molecules, including s...

Histotechnologist

Boston $80,000 - $90,000 Permanent

Job Responsibilities: Process human tissue and body fluid specimens in preparation for microscopic exam Perform technical duties related to th...

Validation Engineer

Cambridge 85K - 100K Permanent

Job Responsibilities: Develop and publish new validation project plans and protocols, execute protocols, and write final reports with minimal su...

Industrial Engineer

Fishers 60 - 80 p/h Permanent

Job Responsibilities: Analyze and evaluate manufacturing processes to identify areas for improvement in terms of efficiency, cost, and quality...