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Senior Manager
2 months ago
Job Summary:
We are seeking an experienced and skilled Head of Contract Manufacturing to lead our production team in the manufacture of Advanced Therapy Medicinal Products (ATMPs). As a key member of our team, you will be responsible for overseeing the production process, ensuring compliance with regulatory requirements, and driving operational efficiency.
Key Responsibilities:
- Develop and implement production strategies to meet client demands and business objectives, ensuring uninterrupted manufacture and supply of ATMPs.
- Oversee management of aseptic suites using KPIs to identify areas for improvement, ensuring 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 (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, 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.
