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Senior Manager of ATMP Manufacturing

2 months ago

Cambridge, Cambridgeshire, United Kingdom Next Phase Recruitment Full time
Job Description

Job Title: Head of ATMP Production

Company: Next Phase Recruitment

Job Type: Full-time

Industry: Pharmaceutical, Biotechnology

Location: Remote (UK)

Job Summary

We are seeking an experienced and skilled Head of ATMP Production to lead our manufacturing team in the production of advanced therapy medicinal products (ATMPs). The successful candidate will have a strong background in GMP manufacturing, production management, and team leadership.

Key Responsibilities
  • Develop and Implement Production Strategies: Develop and implement production strategies to meet client demands and business objectives, ensuring uninterrupted manufacture and supply of ATMPs.
  • Oversee Aseptic Suites Management: Oversee the management of aseptic suites using KPIs to identify areas for improvement, ensuring strict adherence to GMP and other regulations and internal quality standards.
  • Implement Effective Working Practices: Implement effective working practices to ensure optimal quality and safety.
  • 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.
  • Audit and Compliance: Act as a production nominee/primary production point of contact during internal and external audits, including inspections by regulatory authorities.
  • Quality and Compliance: Investigate, evaluate, and review existing practices and methodology, implementing 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.
  • Problem-Solving: Exceptional problem-solving and decision-making abilities, with a track record of meeting production targets and deadlines.