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Manufacturing Technical Lead

Boston $90,000 - $120,000 Permanent

Responsibilities:

  • Manage therapeutic manufacturing processes in line with GMP standards.

  • Drive process optimization to boost efficiency, reduce waste, and minimize downtime.

  • Collaborate with cross-functional teams for seamless tech transfer and scale-up.

  • Provide technical guidance during document reviews and compliance efforts.

  • Monitor process metrics to identify trends and implement improvements.

  • Assist Supervisors with BOM creation and material requests for non-commercial products.

  • Ensure effective utilization of materials and equipment.

  • Troubleshoot operational issues and support Supervisors in resolution.

  • Handle work requests and maintain documentation for Quality Assurance.

  • Address safety concerns and work with EHS and Supervisors to resolve them.

  • Provide feedback to leadership and ensure staff compliance with SOPs and safety guidelines.

  • Develop and conduct training sessions, offering hands-on mentoring to staff.

  • Stay current on industry developments and share relevant updates with the team.

  • Initiate and oversee deviations, collaborating to determine root causes.

  • Assist Supervisors with assessments and implementing corrective actions.

Qualifications:

  • BS/MS in Life Sciences/Engineering with 5+ years of GMP Manufacturing experience.

  • Demonstrated leadership experience in a similar role.

  • Deep understanding of GMP manufacturing processes.

  • Skilled in documentation, compliance, and process improvement.

  • Ability to lead cross-functional teams and drive operational enhancements.

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