Senior External Manufacturing Manager

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A new exciting opportunity to join a very reputable organisation based in Berkshire as their External Manufacturing Manager.

Do you have hands on experience in the development of drugs manufacturing processes and testing of Biologicals, Small Molecules, Sterile or Solid Dosage form products?

Do you have a good knowledge of technical authoring of CMC Regulatory files Sections for commercial products?

Do you have experience with manufacturing and testing technology transfers across organisations, CMOs and CTLs?

If you do, then this could be a great opportunity for you to join a very reputable organisation in Berkshire as their External Manufacturing Manager!

As an External Manufacturing Manager you will be responsible for:

  • Managing external manufacturing and act as the main point of contact between the organisation, CMOs and CTLs.
  • Act as a Subject Matter Expert for external manufacturing and support external manufacturers QA by controlling Quality Critical Documents such as Change Controls, CAPAs, OOS investigations, Unplanned events and Impact Assessments.
  • Writing, checking and reviewing of Key Master Documents such as Protocols, Reports and Plans to facilitate Technology Transfer Activities.
  • Providing technical support for Regulatory CMC related activities and respond to regulatory agencies RSIs (Requests for Supplementary Information).
  • Work closely with the Organisation's international network and provide technical support to other Technical Operations teams when required.
  • Working closely with Subject Matter Experts from External Manufacturers and check and review briefing documents to ensure their compliance.
  • Assist with increasing the awareness of External Manufacturers of various quality standards.

To be considered for this position you must have:

  • A further degree of education or equivalent in a Life Science related subject.
  • Significant hands on experience in the development of drugs manufacturing processes and testing of Biologicals, Small Molecules, Sterile or Solid Dosage form products.
  • Good knowledge of technical authoring of CMC Regulatory files Sections for commercial products.
  • Vast experience in manufacturing and testing technology transfers across organisations, CMOs and CTLs.
  • Up-to-date knowledge of current regulations and cGMP practices.
  • Previous experience with projects management.
  • Strong analytical, problem solving and Root Cause Analysis (RCA) skills.

This opportunity is offering a very competitive salary based on experience.

For more information about the role please contact Mohamed Ismail on

Tel: 0203 096 4702 Mob: 0750 089 1471

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.