Our client is a global leader in the biotech sector who are investing heavily in their Irish presence. This involves the construction of a new state-of-the-art biologics drug substance manufacturing facility in Munster. As a result of the investment and to support the new start-up, this organisation is hiring top talent into their site. They are currently hiring an experienced Principal Microbiologist (AD level).
As Principal Microbiologist (AD) you will be responsible for establishing and implementing the operational microbiological, viral, and environmental monitoring programmes at the manufacturing site. As the Microbiology Lead for the facility, you will provide technical support for the facility startup, defining microbial and viral control strategies in partnership with engineering, operations, quality control and quality assurance.
Other key responsibilities would include:
- You will provide support in up and downstream processing areas and will own activities such as EMPQ and preparation of strategy documentation including contamination FMEA and response plans, and the product protection control strategy.
- You will maximise the benefits of a Digital Plant to gain in depth knowledge of the process through data analytics and Process Analytical Technology.
- You will establish and own the EMPQ Programme, contamination FMEA and contamination response plan.
- You will create, revise, and review documents such as: SOP's, material specifications, protocols, and trend reports (water, environmental monitoring, etc.) and perform investigations as needed.
- You will understand integration of process parameter requirements with MES/electronic batch records to ensure all regulatory, compliance and monitoring needs are captured in manufacturing electronic documentation.
- BSc, MSc or Phd in microbiology, biotechnology, biochemistry, or similar discipline.
- 5 years working in a large molecule GMP manufacturing environment (operating in frontline microbiological support).
- Important to have; in-depth knowledge of biotech manufacturing microbiological controls and associated analytical tests.
- Nice to have; Knowledge of virology controls required for mammalian cell culture, virus, and mycoplasma analytical methodologies.
- Ideal candidate will be a self-starter, strong interpersonal skills, adaptability working cross-departmentally and strong decision-maker. This is an individual contributor position.
To discover more about this opportunity, apply now or contact Déanna Healy at HRM on +353 87 636 9263 for a confidential discussion.