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Senior MSAT Process Engineer, Fill Finish

Date: 05-Oct-2022

Location: Oxford, GB

Company: oxfordbiom

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, and 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 senior Process Engineer or Scientist to work within our Fill and finish facility.  You will be providing technical, engineering, and scientific expertise to enable clinical and commercial manufacturing at Oxford Biomedica and third-party Contract Manufacturing Organisations (CMO) sites.

Your responsibilities in this role would be:

 

  • Define and lead independently the cross-functional activities required to support the introduction of new products on existing manufacturing processes at OXB and third party CMOs to meet internal and/or customer needs.
  • Take an active role in defining and delivering activities / requirements for introduction of new processes to Fill and Finish facility.
  • Lead the introduction of new equipment into GMP manufacturing areas to support process/technology enhancement
  • Lead technical/scientific trouble shooting and problem-solving activities to determine root cause of events and identify suitable mitigation to prevent re-occurrence.
  • Identify & lead implementation of possible improvement projects through consistent data analysis and process performance review to achieve improved productivity, quality and reliability.
  • Identify and lead improvement projects on MSAT ways of working to drive increased effectiveness and customer satisfaction
  • Be primary point of contact for technical support for assigned product(s) within OXB portfolio and for specific process unit as Subject Matter Expert (SME)
  • Coach other MSAT colleagues in recognised areas of expertise to enable effective knowledge sharing and overall knowledge expansion and provide support in delivery of project assigned to lower grades
  • Work will be conducted in compliance with OXB’s Quality Systems and also Health Safety and Environmental (HSE) procedures

 

 

To be successful in this role, you will have the following skills and experience:

 

  • Degree or equivalent experience in Chemical or Biochemical Engineering with an appropriate level of relevant experience.
  • Proven experience in specific areas of GMP biopharmaceutical or gene therapy manufacturing processing: Fill and Finish/Process development / GMP manufacture / Product life cycle management
  • Experience in bioprocess design, scale-up and commercialisation
  • Proven prior experience in Sterile manufacturing and Fill -Finish activities
  • Understands health, safety and environmental aspects of the work carried out and ideally experience in using process hazard analysis (PHA) methodologies such as FMEA, HAZOP and HACCP
  • Knowledge of Quality and Regulatory requirements to enable Clinical and Commercial manufacture
  • Knowledge of cell and gene therapy would be an advantage

 

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.