MS&T Product Steward - ATMP

Dependent on experience
30 Aug 2018
27 Sep 2018
Gregory Hammond
Contract Type
Full Time
We are currently looking for an MS&T Product Steward to join an exciting and expanding Gene Therapy company based in the Oxfordshire area. As the MS&T Product Steward you will be responsible for product stewardship to maintain the technical oversight and knowledge of the clinical and commercial manufacturing processes performed either using in-house manufacturing sites or externally by third party CMOs.


Your duties as the MSAT Product Steward will be varied however the key duties and responsibilities are as follows:

1. Recognised specialist/technical lead responsible for product stewardship; managing the continued (ongoing) process verification (CPV) for the clinical and commercial product(s) assigned.

2. You will provide technical oversight of each assigned products' process performance and capability across all sites and value chain (e.g. from raw materials to vector product primary packaging), through quantitative data trending and monitoring events that may impact the state of control and final product quality.

3. Ensure commercial product' processes remain in a state of control (validated state) end to end, across multiple sites, in liaison with Manufacturing Sciences & Technology (MSAT), Manufacturing and Quality functions.

4. Managing the performance of Process Analysts. Working with manager to set clear performance expectations; provide coaching, mentoring and pastoral support.


To be successful in your application to this exciting opportunity as the MSAT Product Steward we are looking to identify the following on your profile and past history:

1. Relevant degree / masters / PhD / EngD in Biochemical Engineering, Biotechnology, Life Science or similar.

2. Proven industry experience in cell and gene therapy or biopharmaceutical / biologics manufacturing would be an advantage.

3. A working knowledge and practical experience with bioprocess development, scale-up and GMP manufacturing (including large scale mammalian cell culture support).

Key Words: Product Steward, MS&T, MSAT, Upstream, Downstream, USP, DSP, Biopharmaceuticals, Biologics, Gene Therapy, GMP, Process Control, RCA, Manufacturing, Aseptic, Process Performance Monitoring, Post-Approval CMC.

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.

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