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Director of Manufacturing

2 months ago

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

Join our innovative biotechnology company as we embark on an exciting phase of expansion. We are seeking an experienced Director of Manufacturing to oversee the development and implementation of manufacturing processes and frameworks across our GMP cleanroom facilities for DNA production.

Key Responsibilities:
  • Continuing the expansion and development of manufacturing processes and frameworks across the GMP cleanroom facilities for DNA production.
  • Supporting technology transfer projects from the research and development teams.
  • Spearheading departmental improvements as the facilities grows, evaluating existing processes and improving areas such as costs, quality, time etc.
  • Acting as a point of contact for external regulatory body communications, audits, regulatory submissions etc.
  • Building and overseeing cross-departmental relationships with R&D, quality, regulatory teams etc.
  • Leading the daily organisational 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 optimisation 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 benefits package including bonus, stock options and private health insurance. As an up-and-coming Cambridge Biotech, we are able to provide a generous base salary, with benefits, bonus and share options.