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Manufacturing Operations Team Lead

Manufacturing / Production
Adam Cambridge
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Job Reference: JO-2001-64979_1580129109


The primary role of the Operations Team Lead is to manage the daily manufacturing operations; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met in this world class biologics site.


  • People management of direct reports of biotechnicians and shift leads (8-15)

  • Lead and support the manufacturing team in the manufacture of drug substance material under cGMP conditions.

  • Ensure schedule adherence, assist in manufacturing troubleshooting and facilitate appropriate escalation.

  • Support and partner closely with the Manufacturing Managers, Operations Team Leads, Shift Leads and Biotechnicians and other colleagues

  • Ensure training, master batch records, SOPs and other documents are current and compliant under cGMP conditions - ensure training, manufacturing systems and practices are consistent throughout the organization.

  • Lead and support daily operation of processing systems and partner with plant engineering colleagues to ensure equipment is reliably maintained and within appropriate calibration.

  • Partner with validation subject matter experts, prepare/approve validation protocols, validation plans, protocol executions, and summary reports in support of ongoing revalidation and validation efforts required for commercial manufacturing.

  • Instil the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.

  • Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance

  • Coach, mentor and train shift leads and biotechnicians on manufacturing processes, use of operational excellence tools, and high performance team behaviours.

  • Participate and support plant optimization that helps create a strong value proposition for future investment.

  • Strong focus of MFG metrics and status with particular focus on release cycle times.


  • Bachelor degree in biotechnology, chemical or biochemical engineering, biochemistry or bio-systems engineering or related field or equivalent experience in a GMP environment is preferred.

  • Demonstrated experience working with MFG processes in production including hands on experience in either:

    • Cell culture bioreactor, seed lab and harvest operations or

    • Chromatography, ultra-filtration, and other purification unit operations or

    • Support services unit operations; media/buffer preparation, autoclave and parts washer

  • Past experience and demonstrated ability to successfully influence team performance in a high performance team is strongly preferred.

  • Track record of embedding a strong Quality culture. Trackwise experience preferred.

  • Demonstrate strong communication skills and the ability to interact across cross-functional teams.

  • Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results.

  • Experience with regulatory inspections and direct interaction with regulatory inspectors.

  • Highly developed organizational and leadership skills.

  • Process development and/or technology transfer experience preferred

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Adam Cambridge
Adam Cambridge
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Supply Chain & Operations
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