Process Compliance Officer - 12 month FTC

Oxford, England, United Kingdom

12/21/2024

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.

We are currently recruiting for a Process Compliance Officer to join the Manufacturing team on a 12 month fixed-term contract. The purpose of this role is to work alongside the GMP Manufacturing teams to ensure the timely completion of batch related issues, as well as ensuring compliance with internal and external GMP requirements.

Our manufacturing team is a critical part of Oxford Biomedica’s operations. We produce multiple clinical and commercial lentiviral vector based gene therapy products

Your responsibilities in this role would be:

• Lead investigations and root cause analysis into process and facility deviations
• Identify and implement effective Corrective and Preventative Actions (CAPAs)
• Conduct regular self-inspections of the Manufacturing department.
• Organise and facilitate individual and group training with regard to manufacturing SOPs and procedures.
• Lead updates to batch and facility documentation to capture new learnings and best practices.
• Lead and promote process improvement ideas to increase the department’s efficiency.
• Key link between the QA department and the Manufacturing department.
  
  

We are looking for:

• Experience of working within a GMP pharmaceutical/biotechnology environment.
• Experience of leading and being a part of structured problem solving events.
• Experience with Manufacturing documentation such as SOPs, Deviations, Change Controls Risk Assessments and CAPAs
• Competency in Microsoft Office
• Familiarity with Root Cause Analysis techniques and the ability to amalgamate and interpret complex data in an investigative capacity would be an advantage
• Demonstrable process orientated approach to investigations.
• Organised, self-motivated, pragmatic, and have an excellent attention to detail.
• Have experience of continuous improvement
  
  

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.

OXB 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. OXB’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: 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