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.
EXPERIENCE & QUALIFICATIONS:
- 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
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