Manufacturing Manager

Date Posted:
Town/city, county:
Santa Cruz, California
Life Sciences

Job Description:

Gilbert Meher are exclusively partnered with a pioneering diagnostics company who are developing transformative genomics-based solutions for Infectious Disease Testing. As they expand, they are seeking a Manufacturing Manager.  

Reporting directly to VP level, the incumbent will become an integral member of the team, leading on reagent and NGS kit manufacturing. The role will require a mixture of external manufacturing management and internal manufacturing oversite, in line with Quality Management Systems.
The ideal candidate will be based in the Santa Cruz region or willing to relocate.

  • Lead the transferring of internal manufacturing to an external Contract Manufacturing Organisation, identifying the organisation and subsequently managing the relationship.
  • As the key responsible for day-to-day production of reagents throughout formulation, filling and packaging activities, intended for Research and Clinical use.
  • Review manufacturing documentation (e.g SOPs, batch records), revising and drafting as required.
  • Oversee Supply Chain, managing activities throughout supplier quality, inventory levels and purchasing and ensuring consumables are up to date.
  • Work cross-functionally with Quality Assurance to participate in product risk assessments and participate in internal and external auditing.
  • Lead training programs throughout operations and manufacturing to ensure all staff are compliant and up to date and compliant.
  • Implement tools to ensure reagent performance is tacked.
  • Willing to perform hands-on manufacturing technician work as required to meet business-critical deadlines.
  • Scientific BSc or MSc.
  • >3 years’ experience working in the Molecular Biology or Chemical industry.
  • Direct experience in the manufacturing of reagents and kits preferred, but experience in the manufacturing of chemicals for the molecular biology space also considered.
  • NGS experience preferred.
  • Proven track-record working in an ISO13485 and GMP regulated environment.
  • Proven experience with the management of CMOs, including selection and oversite, ensuring compliance with Quality Management Systems.
  • Driven by the start-up environment.

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