[ref. a15400500] Process Engineer - MSAT

Job description:

Process Engineer /Scientist

We want you to feel inspired every day. We’re future-focused and our business is growing. We succeed together through passion, commitment and teamwork, and so can you.

OXB’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 two Process Engineer or Scientists to join the team. One of the main purposes of this role is to plan, execute and report completion of MSAT-related projects or tasks in alignment with department objectives

Your responsibilities in this role would be:

• Delivering assigned technical projects/tasks working directly with your manager to ensure project timelines are met according to internal and/or customer needs
• Trouble shooting, identification and problem solving in the plant for process and quality issues of existing processes
• Supporting the implementation of new processes/products into OXB facilities and third party CMOs
• Supporting improvement projects to achieve increased productivity improvement, quality and reliability improvements
• Analysing batch records and quality results and monitors consistency of operations by using appropriate database and statistical tools; propose and implement corrective and improvement actions
• Working will be conducted in compliance with OXB’s Quality, Safety and Environmental systems and procedures

We are looking for:

• Relevant degree or equivalent experience
• Knowledge of GMP manufacturing, including quality and regulatory requirements
• Knowledge and relevant experience in the scale up and commercialisation of GMP manufacturing bioprocesses
• Understanding of quality management systems, environmental, health and safety aspects of the work and regulatory requirements
• Experience of using statistical data analysis tools
• Understanding of Process Hazard Analysis (PHA) methodologies such as FMEA, HAZOP and HACCP would be desirable

About Us:

OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.

These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

What’s in it for you:

• Highly competitive total reward packages
• Wellbeing programmes
• Development opportunities
• Welcoming, friendly, supportive colleagues
• A diverse and inclusive working environment
• Our values are: Responsible, Responsive, Resilient, Respect
• State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.

Collaborate. Contribute. Change lives

We offer:

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.

This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).

Oxford Biomedica's world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods and depth of regulatory expertise.