You will be joining a highly successful organisation in the cell therapy / ATMP sector. Previous experience in this sector is not essential, as they are so unique. Instead, candidates will be welcomed from QC departments of Pharmaceutical or Biotech environments, including aseptic / sterile production of vaccines, chemotherapy drugs or similar. Provided you have a strong understanding of Bioburden, Endotoxin, Micro-organism identification and related techniques, candidates can be considered from a range of settings.
This is a permanent position, paying a competitive salary depending on experience (negotiable around the “mid to late 50s”), plus excellent benefits as listed below.
The Role
Based on-site in Edinburgh, you will have one direct report initially, who in turn supervises around 15 people in Microbiology, Analytical and Raw Material testing labs. As such, you will be indirectly responsible for a department that works in a very efficient and collaborative way but is going to be growing and therefore needs clear, strategic direction based on sound scientific expertise. You will supervise the application of microbiological techniques and operations regarding the testing of in-process, bulk release and GMP raw materials. You will have a range of duties, including:
- Supervision of all microbiological and Environmental Monitoring QC testing including environmental, raw material, in-process and final product samples and techniques such as total particulate, Bioburden, Endotoxin and growth promotion testing, as well as microorganism identification.
- Direct management of the QC Microbiology laboratory and operations within.
- Supervision of the review of laboratory data and the close out of deviations.
- Scheduling of microbiological testing alongside other departments.
- Authoring and review of change controls, deviations/investigations, test methods, specifications and SOPs.
- Management of regulatory requirements from MHRA and FDA.
- Supervision of introduction of new methods including Qualification and Validation of new microbiological assays.
- Acting as Subject Matter Expert for microbiology laboratory testing.
- Running and co-ordination of continuous improvement projects.
- Ensuring up-to-date training status of all QC Microbiology personnel in line with cGMP and provision of specialist training as necessary.
- Continued coaching and developing of the QC Microbiology team to help staff meet both their career and personal development goals ensuring a cohesive, productive and highly motivated team.
Benefits
In addition to a very competitive salary (negotiable depending on experience, but likely to be in the “mid to late 50s”, the company offers:
- Excellent pension scheme (up to 8% employer contribution)
- 31 days’ holiday, plus 4 public holidays
- Private healthcare
- Various employee discounts, fun social events and voluntary incentive schemes
Experience
The successful candidate will be a hard-working, passionate Microbiologist who enjoys working in a regulated GMP environment and is able to wear different ‘hats’ depending on the situation. At times you will need to be more strategic, and at other times more hands-on in providing support with advanced microbiological techniques and ensuring correct processes are followed. You will need to have a supportive leadership style and the ambition to join a fast-paced company that is growing and evolving quickly. You will need to have a degree (BSc, MSc or PhD) in Microbiology or similar, with significant experience with techniques such as bioburden, endotoxin and others.
Full details will be provided on application.