Head of Commercial and Contract Management

2 months ago

Cambridge, Cambridgeshire, United Kingdom SLS Services Limited Full time
Job Description

Head of ATMP Production

We are seeking a highly experienced and skilled professional to lead our ATMP production team at SLS Services Limited. 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.

The ideal candidate will have a strong background in GMP manufacturing of ATMPs, significant experience in production management within the cellular therapy field, and a comprehensive understanding of cGMP, regulatory guidelines, and quality systems.

Key Responsibilities:

  • Develop and Implement Production Strategies: Create and execute production strategies to meet client demands and business objectives, ensuring uninterrupted manufacture and supply of ATMPs.
  • Manage Aseptic Suites: Oversee the management of aseptic suites, using KPIs to identify areas for improvement, and ensure strict adherence to GMP and other regulations and internal quality standards.
  • Facility Design and Management: Play a key role in facility design, capital projects, commissioning, and validation, with specific support of future cleanroom expansion.
  • Team Leadership: Lead and manage a cross-functional team, providing guidance, training, and mentorship to ensure optimal performance and professional development throughout the department.
  • Technical Guidance: 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.
  • Regulatory Compliance: Act as a production nominee/primary production point of contact during internal and external audits, including inspections by regulatory authorities.
  • Process Improvement: 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.
  • Accreditation and Licensing: Perform tasks required for accreditation and licensing of the cleanroom facilities and clinical products by regulatory bodies, including the MHRA.

Requirements:

  • Education: BSc or MSc in a relevant scientific discipline (Pharmaceutical Sciences, Biotechnology, Biochemistry, or equivalent).
  • Experience: 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.
  • Skills: Comprehensive understanding of cGMP, regulatory guidelines, and quality systems, experience of laboratory electronic management systems (LIMs, EMS, eBMR), project management, and planning.
  • Leadership: Strong leadership and team management skills, with the ability to motivate and inspire others to foster a culture of collaboration, excellence, and continuous improvement.

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