Process Analyst, MSAT
- Experience Level
- Experienced (non-manager)
Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.
Oxford Biomedica’s Manufacturing, Science and Technology Team is responsible for process and technology development activities from early concept through to product registration for market approval, to ensure that OXB’s new and existing manufacturing processes can deliver the productivity, performance, quality and cost benefits required in line with regulatory guidance.
We are currently recruiting for a talented Process Analyst to join the team. One of the main purposes of this role is the routine (and where required non-routine) analysis of data generated during manufacturing and testing of Oxford Biomedica (OXB) manufactured products across the product lifecycle.
Your responsibilities in this role would be:
- Collation and statistical analysis of manufacturing and analytical data to monitor process performance and capability of clinical and commercial product(s).
- Regularly monitoring of quantitative data using statistical software; including critical and key process parameter and quality attributes, in-process controls, yields and process step cycle times as appropriate to identify improvement areas.
- Present and report data at meetings including the Manufacturing Robustness Review Board (MRRB) Meeting.
- To use captured process data and statistical analysis of OXB-manufactured product process performance and capability to evaluate the state of control of manufacture, to re-evaluate the suitability of quality limits and to identify possible improvement areas to reduce process variability.
- To collate all related events that could impact process performance including changes in material lot numbers or supplier, deviations, change controls, process excursions to identify and/or justify any trends or shifts in manufacturing and analytical data.
- Support root cause investigations into process excursions [Out-of-Specification (OOS), Out-of-Expectation (OOE) and Out-of-Trend (OOT)].
- To prepare regular reports on process performance and capability for internal and strategic partner queries which the Continuous Process Verification and Annual Product Quality Review (APQR) reporting.
To be successful in this role, you will have the following skills and experience:
- Life Sciences Degree, Biotechnology, Chemical engineering or related discipline preferred.
- Proven competency in the use of statistics and statistical software through direct experience or academic qualification.
- Previous biological/chemical manufacturing experience in a GMP regulated environment would be an advantage.
- An interest in operational excellence and continuous process improvement is desirable.
Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.
Collaborate. Contribute. Change lives
No agencies please.