Head of Manufacturing Operations

2 days ago

Cambridge, Cambridgeshire, United Kingdom Cranleigh Scientific Full time
Head of Assembly

Cranleigh STEM is collaborating with a leading Contract Development and Manufacturing Organisation (CDMO) to find an experienced Head of Assembly to join their expanding team. This organisation specialises in the GMP manufacturing of Advanced Therapy Medicinal Products (ATMPs), as well as process development and related services, supporting the development of breakthrough therapies for life-threatening conditions.

Role Overview:

The Head of Assembly will play a critical role in leading and managing the manufacturing operations, ensuring efficiency and compliance while developing a high-performing team. The successful candidate will be responsible for overseeing the assembly of complex and specialised ATMPs, facilitating the introduction of new products into clinical production, and driving operational excellence across the department.

Key Responsibilities:
  1. Develop and implement assembly strategies to meet client demands and align with business goals.
  2. Oversee staff and facility scheduling to ensure uninterrupted manufacturing and supply of ATMPs.
  3. Manage assembly suites using KPIs to drive continuous improvement and ensure compliance with GMP regulations and internal quality standards.
  4. Introduce and maintain effective working practices, including shift systems, to optimise assembly processes.
  5. Take a leading role in facility design, capital projects, commissioning, and validation, with a particular focus on cleanroom expansion.
  6. Lead and mentor a cross-functional team across multiple sites, fostering professional development and ensuring optimal performance.
  7. Provide strategic and technical guidance in areas such as complex cell manufacturing, technology transfer, and process automation.
  8. Act as the primary assembly contact during internal and external audits, including regulatory inspections.
  9. Continuously assess and improve current practices and methodologies, ensuring compliance with UK regulatory requirements and enhancing assembly quality standards.
Requirements:
  1. MSc in Pharmaceutical Sciences, Biotechnology, Biochemistry, or a related discipline (or equivalent experience).
  2. Proven expertise in GMP manufacturing of ATMPs and experience in assembly management, ideally within a CDMO environment.
  3. A successful track record in scaling up and scaling out ATMP manufacturing processes.
  4. Comprehensive knowledge of cGMP, regulatory guidelines, and quality systems.
  5. Experience with laboratory electronic management systems (LIMs, EMS, eBMR) and project management.
  6. Strong leadership and team management skills, with the ability to inspire a culture of collaboration, excellence, and continuous improvement.
  7. Excellent problem-solving abilities and a proven track record of meeting assembly targets and deadlines.

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