Biotechnology Manufacturing Director

2 weeks ago

Cambridge, Cambridgeshire, United Kingdom taylorollinson Ltd Full time
Job Description

Our client, a leading biotechnology company, is seeking an experienced Biotechnology Manufacturing Director to oversee the expansion of their DNA production capabilities. The successful candidate will be responsible for continuing the development of manufacturing processes and frameworks across the GMP cleanroom facilities.

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.
  • 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:

Our client is able to offer a competitive salary, progression options and benefits package including bonus, stock options and private health insurance.

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