Head of ATMP Production
2 weeks ago
Head of ATMP Production required for a cell therapy CDMO who have a state-of-the-art facility based near Cambridge for multiproduct GMP production. This site allows scale up of current commercial production and the provision of contract manufacturing services to meet the growing demand for such services in the UK.
The Head of ATMP Production will lead their growing manufacturing team overseeing the complex and specialized manufacturing and production activities. The Head of ATMP Production will be pivotal in leading the manufacturing operations, driving operational efficiency, and developing the Production Department into a new era of excellence. In collaboration with the Production Manager, this role will be responsible for developing a highly skilled team, guaranteeing optimal quality and safety, and ease new products into clinical production, working closely with internal and external stakeholders.
On offer is a competitive salary for industry which includes a range of benefits. This will be disclosed over the phone.
Responsibilities of the Head of ATMP Production include:
- Develop and implement production strategies to meet client demands and business objectives and to ensure uninterrupted manufacture and supply of ATMPs.
- Oversee management of the aseptic suites using KPI’s to identify areas for improvement, ensuring strict adherence to GMP and other regulations and internal quality standards.
- Implement effective working practices.
- Play a key role in facility design, capital projects, commissioning, and validation with specific support of future cleanroom expansion.
- Lead and manage a cross functional team (Sawston and London), providing guidance, training, and mentorship to ensure optimal performance and professional development throughout the department.
- Provide strategic and scientific guidance in technical areas supporting complex cell manufacturing including technology transfer, maximising production efficiency and implementation of new processes and automation.
- Act as a production nominee/ primary production point of contact during internal and external audits, including inspections by regulatory authorities.
- Investigate, evaluate and review existing practices and methodology and implement improvements to ensure current quality standards are maintained, evaluated and improved as well as address any compliance-related concerns.
- Perform tasks required for accreditation and licensing of the cleanroom facilities and clinical products by regulatory bodies, including the MHRA.
The required skillset to be the successful candidate:
- BSc or MSc in relevant scientific discipline (Pharmaceutical Sciences, Biotechnology, Biochemistry or equivalent).
- Significant experience and expert in GMP manufacturing of ATMPs and significant experience in production management within the cellular therapy field, ideally experience in a CDMO setting.
- Comprehensive understanding of cGMP, regulatory guidelines, and quality systems.
- Experience of laboratory electronic management systems (LIMs, EMS, eBMR), project management and planning.
- Strong leadership and team management skills with the ability to motivate and inspire others to foster a culture of collaboration, excellence, and continuous improvement.
- Exceptional problem-solving and decision-making abilities with track record of meeting production targets and deadlines.
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