Job Description
Microbiology Lead (Director)
Do you want to shape microbiology strategy for a new biopharmaceutical manufacturing facility?
Are you ready to lead contamination control and environmental monitoring programmes in a GMP setting?
Do you enjoy influencing site design, processes, and compliance from the ground up?
Fraser Dove International is partnering exclusively with a leading biopharmaceutical manufacturing organisation. Operating in a state of the art facility, they are committed to delivering safe, high quality medicines through compliant and efficient operations.
Our client is seeking a strategic leader to lead microbiology programmes and contamination control across the site.
Discover more about our Microbiology Lead opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
Your objectives:
As the Microbiology Lead, you will be measured against the following objectives:
- Establish and maintain a robust environmental and utility monitoring programme aligned with regulatory expectations and site needs.
- Develop and implement a comprehensive contamination control strategy to minimise risk across manufacturing operations.
- Ensure microbiological compliance and audit readiness, supporting successful inspections and continuous improvement.
What you will do:
As the Microbiology Lead, your duties and responsibilities will include:
· Design and implement environmental and utility monitoring programmes tailored to facility requirements.
· Develop and validate sampling procedures in line with regulatory standards including Food and Drug Administration (FDA), European Medicines Agency (EMA), and United States Pharmacopeia (USP).
· Act as a subject matter expert in contamination control, supporting facility design, material flow, and personnel practices.
· Develop standard operating procedures (SOPs) and best practices for contamination prevention in manufacturing processes.
· Lead investigations into microbiological excursions and implement corrective and preventive actions (CAPA).
· Support internal and external audits, ensuring compliance with current Good Manufacturing Practice (cGMP).
· Deliver training and prepare documentation related to microbiology programmes and processes.
What you will bring:
These are the skills and experience you will need to succeed as the Microbiology Lead:
· Significant experience in microbiology within a GMP regulated biopharmaceutical environment.
· Proven expertise in environmental monitoring and contamination control programme development.
· Experience supporting facility start up, qualification, or new site build activities.
· Strong understanding of global regulatory requirements including USP, EMA, and FDA.
· Proficiency in risk assessment and data analysis for microbiological processes.
· Bachelor of Science (BSc) in Microbiology, Biology, Biochemistry, or a related field.
· Master of Science (MSc) or Doctor of Philosophy (PhD) in a relevant discipline is desirable.
Got what it takes?
To apply for the Microbiology Lead, click the ‘Apply’ button below or contact the Executive Search Consultant – [REECE WIGGINS] – on +44 (0)203 355 7050.
Please Note:
· This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
· If you have not heard from an Executive Search Consultant within ten working days from the date of your application, please consider yourself unsuccessful on this occasion.
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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.