Senior Process Engineer/Scientist

Job description:
 

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.  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.

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: Process development / GMP manufacture / Fill and Finish/ Product life cycle management
• Experience in bioprocess design, scale-up and commercialisation.
• 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.

About Us:

Oxford Biomedica 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.

Oxford Biomedica collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. 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.

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: Deliver Innovation, Be Inspiring and Have Integrity
• 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

Profile description:

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: Process development / GMP manufacture / Fill and Finish/ Product life cycle management
• Experience in bioprocess design, scale-up and commercialisation.
• 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.

About Us:

Oxford Biomedica 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.

Oxford Biomedica collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. 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.

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: Deliver Innovation, Be Inspiring and Have Integrity
• 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.  

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. 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 collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. 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.