This is a newly created role for a Quality Control Microbiologist to join the QC team and help build up the company’s growing analytical testing capability. This is part of an exciting expansion in 2021 and will be followed by additional hiring and more opportunities. We are looking for an adaptable, energetic, collaborative, honest and versatile person to join this pioneering company who are at the forefront of T-cell therapy.
This is a permanent position, paying a very generous salary, annual bonus and healthcare, to discuss on application. You will be based on site in modern premises in Stevenage, Hertfordshire, and will work normal office hours on site, Monday to Friday.
Your role will include:
- Executing QC release assays for the analysis of raw materials, finished products, environmental monitoring samples and more
- Developing microbiological methods including bioburden, endotoxin, viable count etc
- Supporting the QC team in the QC laboratory development and in qualification and maintenance of equipment and assays
- Designing and implementing assay qualification protocols for final product and in process testing
- Implementing and maintaining GMP standards
- Preparing and reviewing SOP’s
- Drafting and leading Out of Specification and Laboratory Investigations
- Troubleshooting technical and quality issues
Skills and Experience Required:
- Life science qualification – ideally a degree minimum in microbiology or similar
- Strong experience gained in a Biologics, Cell Therapy / ATMP, sterile manufacturing or Biopharmaceutical organisation, regulated to GMP standards
- In-depth knowledge of microbiological techniques, such as endotoxin, bioburden, viable count, culture ID, sterility testing, MALDI-TOF and API systems etc. Experience in all of these is not essential.
- Excellent communication skills and ability to work with people at all levels
- Proactive, driven, pragmatic, open-minded, emotionally intelligent, positive and respectful approach to your work
Full details will be provided on application. This is a permanent role in Stevenage, Hertfordshire