As a leading biologics manufacturer, our client offers comprehensive, integrated and customised services to over 200 clients globally including 13 of the top 20 biopharmaceutical companies worldwide. Establishing a new state-of-the-art campus in Leinster, the company now requires an experienced Senior Scientist - QC Microbiology to join the business.

The Role

The QC Micro Snr Scientist will report into the AD of Microbiology. Duties and responsibilities include:

Specific Start-Up Activities:

• Support QC Microbiology lab set-up, including laboratory design and construction queries, equipment installation and qualification utilising principles of Operational Excellence and Lean Labs
• Microbial organism identification, supporting facility qualification, cleaning validation, process validation, etc
• Develop and maintain quality systems within the QC Microbiology Laboratory to ensure compliance to cGLP
• Support of the commissioning/qualification activities of utility systems including but not limited to Water systems, Clean Steam and process gases, including development of sampling strategies

Sustaining Operations:

• Lead QC microbiology routine testing, environmental monitoring, water monitoring, and testing including, sterility, endotoxin, bioburden, Biological Indicators, Growth promotion and routine microbial identification strategies
• Serve as a technical expert to lead OOS, OOL, microbial contamination, adverse trends, utility and environmental excursion investigations, change controls, and CAPAs
• Defines specific aseptic techniques to be performed for crucial process steps and provides meaningful input to processing operations as site develops
• Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development
• Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits

The Person

The successful candidate will have qualifications and experience in the following:

• PhD with/without post doc experience or MSc in Microbiology or related field desired
• Previous experience in a Quality Control/GMP environment is a plus
• Experience with regulatory/customer audits is a plus
• Management/supervision of personnel with particular attention to schedules and shifting priorities and training/coaching of personnel
• Possesses detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines is a plus
• Ability to think critically and demonstrate troubleshooting and problem-solving skills
• Excellent interpersonal, verbal, and written communication skills

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.