Manufacturing Manager

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.

Responsibilities:

- 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.

Requirements:

- 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.