Director of Manufacturing

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom taylorollinson Ltd Full time
Job Title: Director of Manufacturing

Join our innovative biotechnology company as we expand our DNA production capabilities. As Director of Manufacturing, you will oversee the development and implementation of manufacturing processes and frameworks across our GMP cleanroom facilities.

Key Responsibilities:
  • Continuing the expansion and development of manufacturing processes and frameworks for DNA production.
  • Supporting technology transfer projects from our research and development teams.
  • Spearheading departmental improvements as our facilities grow, evaluating existing processes and improving areas such as costs, quality, and time.
  • Acting as a point of contact for external regulatory body communications, audits, and regulatory submissions.
  • Building and overseeing cross-departmental relationships with R&D, quality, and regulatory teams.
  • Leading the daily organizational activities of the GMP team and taking responsibility for staff training.
  • Acting as a point of contact for external clients with respect to project updates and regulatory plans.
  • Managing troubleshooting and problem-solving projects, liaising with Quality to ensure CAPAs are in place and completed.
Requirements:
  • BSc / MSc / PhD in Biology (or equivalent biological degree) (desired)
  • Proven experience in developing manufacturing processes of biological products (therapeutics / drug substances / excipients) (essential)
  • Expertise within internal technology transfer of R&D projects to manufacturing, including scale-up, process optimization, and stability testing (essential)
  • Prior experience working within a GMP environment and strong understanding of GMP documentation (essential)
  • Understanding of quality assurance processes for biologicals manufacture (process validation, CAPAs, etc.) (essential)
  • Extensive understanding of regulations from FDA / MHRA / EMA and common issues related to biologics (essential)
  • A background that involves molecular biology (ideal/desired)
  • Sterile injectables experience (desired)
The Package:

We offer a competitive salary, progression options, and a benefits package including bonus, stock options, and private health insurance. As an up-and-coming Cambridge Biotech, we are committed to providing a supportive and dynamic work environment that fosters growth and development.

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