Senior QC Microbiologist

3 weeks ago


Cowley, United Kingdom OXB Full time
About the Role

Oxford Biomedica is seeking a highly skilled Senior QC Microbiologist to join our team. As a key member of our quality control team, you will be responsible for ensuring the highest standards of quality and integrity in our manufacturing processes.

Key Responsibilities
  • Supervise and support a team of microbiologists to ensure the quality and integrity of our products.
  • Plan, organize, and perform testing of raw materials, in-process, intermediates, and final product samples to ensure compliance with regulatory requirements.
  • Maintain accurate and detailed records of microbiological test data.
  • Ensure the microbiology laboratory is maintained to GMP standard and equipment is calibrated, maintained, cleaned, and monitored appropriately.
  • Develop and review SOPs, protocols, and reports to ensure compliance with regulatory requirements.
  • Communicate and initiate deviations or out-of-specification (OOS) results to manufacturing and other relevant departments to ensure timely corrective actions.
  • Represent the microbiology laboratory in communications with manufacturing and supply chain to synchronize microbial testing as needed.
Requirements
  • Degree in Microbiology or other Life Science, or significant supplementing industry GMP QC Microbiology experience.
  • Excellent knowledge of cGMP requirements, with a focus on documentation and laboratory activities to ensure compliance.
  • Good understanding and knowledge of practical and theoretical microbiology techniques and aseptic techniques to enable effective and accurate environmental monitoring and microbial testing.
  • Thorough understanding of GMP and cleanroom biocontamination control.
  • Relevant experience in microbiology laboratory and GMP/clean rooms.
  • Monitoring regulatory/industry updates.
  • Experience in bioburden testing, environmental monitoring, endotoxin testing, sterility testing, media qualifications, and growth promotion testing.
  • Working within ISO 8 to ISO 5 clean rooms and experience within aseptic fill finish activities.
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. We collaborate 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.

What We Offer
  • 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.