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Head of Manufacturing

Oxfordshire   •  Negotiable  •  Permanent, Full time


A growing pharmaceutical company has an exciting opportunity for a Head of Manufacturing to join its team. This is a new role to help move the company's award winning technology through the tech transfer and manufacturing processes to CDMO's and clinical trial applications. Applicants with extensive experience within the pharmaceutical industry, GMP aseptic manufacturing experience and CDMO transfer and process validation are invited to apply.

Duties will include:

  • Lead the vendor selection process of CDMOs
  • Support tech transfer activities from company to CDMOs
  • Document generation and review, particularly regarding process qualification
  • Oversight of pre-clinical and clinical manufacturing materials ordering, testing, approval etc.
  • Support regulatory and quality aspects of the clinical line setup and operation
  • Oversight of the management of CDMOs and clinical manufacturing
  • Management of manufacturing processes from batch completion to the clinical trial
  • Provide quality oversight and organisation of batch release
  • Management of Drug Product manufacturing sections of clinical trial application documentation
  • Support of interactions with regulatory authorities
  • Support of strategic planning for process development activities
  • Maintain H&S standards
  • Maintain quality standards

Requirements

  • Relevant BSc degree or higher.
  • Significant experience of working in the pharmaceutical industry with GMP aseptic manufacturing experience and CDMO transfer and process validation.
  • GMP aseptic manufacturing experience
  • Proven line management experience
  • Experience of managing Contracts and Contractors.
  • Strong written and verbal communication skills with the ability to proactively lead and progress work to meet agreed deadlines
  • Self motivated and goal orientated
  • Strong organisational and prioritisation skills
  • Experience in biologics or vaccine is desirable.


You must have the right to work in the UK. Learn more

  • Agency: Cranleigh Scientific
  • Reference: 7181
  • Posted: 7th January 2022
  • Expires: 4th February 2022

Cranleigh Scientific

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