J56393HertfordshireBiotechnology CRO/CMO Science PermanentDependent on experienceFull Time09/07/2018Biochemistry Biochemistry – Fermentation / Upstream Processing Biochemistry - Expression Biochemistry – Purification Biochemistry – Development / Validation Biochemistry – Production / Manufacturing Cell Culture Technology Transfer
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HRS are currently recruiting for a CMC External Supply Manager to join an exciting and innovative Gene Therapy company based in the Hertfordshire area. As the CMC External Supply Manager you will be responsible for overseeing the day to day management of technology transfers to external parties, ensuring the ongoing compliant supply and maintaining timelines and budgets.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the CMC External Supply Manager will be varied however the key duties and responsibilities are as follows:
1. Plan & ensure secure compliant supply of critical materials for the product portfolio (both internal & external GMP production).
2. Lead technology transfer teams and as tech transfer lead, play a key role in CMC matrix teams delivering the overall CMC/supply for development projects.
3. Oversee activities focused on manufacturing support & trouble-shooting (across all stages of manufacture including aseptic processing and fill/finish) for investigation of process failures, quality incidents, deviations, corrective/preventative action plans, and change controls.
4. Build expertise in aseptic processing, fill-finish, inspection and packaging to support in-house and third-party contract manufacturing operations, providing guidance on best practices to improve aseptic processes and procedures.
To be successful in your application to this exciting opportunity as the CMC External Supply Manager we are looking to identify the following on your profile and past history:
1. Relevant degree, (Masters / PhD / EngD) in a relevant Life Science or Engineering Discipline, such as Biotechnology, Biochemistry or Biochemical Engineering.
2. Proven industry experience in developing robust and scalable GMP compliant processes for either gene therapy, viral vectors, vaccines, or biological products; including knowledge spanning upstream; downstream and fill/finish technologies
3. A working knowledge and practical experience with technology transfer, management of CRO's/CMOs and/or GMP manufacturing, providing technical expertise to assist troubleshooting issues, during technical transfer or routine production.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.