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Head of Commercial and Contract Management
2 months ago
Job Title: Head of ATMP Production
Job Summary:
We are seeking an experienced and skilled professional to lead our ATMP Production team. As the Head of ATMP Production, you will be responsible for overseeing the complex and specialized manufacturing and production activities, driving operational efficiency, and developing the Production Department into a new era of excellence.
Key Responsibilities:
- Develop and implement production strategies to meet client demands and business objectives, ensuring uninterrupted manufacture and supply of ATMPs.
- Oversee management of the aseptic suites, using KPIs to identify areas for improvement, and ensure strict adherence to GMP and other regulations and internal quality standards.
- 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, 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, maximizing 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.
Requirements:
- BSc or MSc in a relevant scientific discipline (Pharmaceutical Sciences, Biotechnology, Biochemistry, or equivalent).
- Significant experience and expertise 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 a track record of meeting production targets and deadlines.
