Barden are delighted to be supporting our client in their search for a Principal Analytical Microbiologist for their state-of-the-art start up biotech manufacturing campus in Limerick.
ABOUT THE ROLE:
The Principal Analytical Microbiologist will provide the analytical technical leadership for all aspects of microbiological technologies and methods
Roles & Responsibilities:
- Provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and projects.
- Development, technical transfer and validation of the methods and their associated lifecycle will be a key aspect of this role.
- Lifecycle management of existing technologies and instrumentation.
- Support the introduction, validation and on-going technical agenda for pipeline and commercial analytical methods and technology.
- Ensure methods are scientifically robust with the required performance attributes to satisfy stakeholder needs.
- Execute and/or oversee testing protocols in accordance with local procedure and regulatory requirements.
- Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
- Provide training and mentorship to QC team members and cross functionally.
- Function as SME for one or more technologies and / or business systems within QC. (This will include the identification, sourcing, installation, and qualification of new equipment.)
- Assure that all raw materials, utilities, including environmental, in-process samples or final products are appropriately analyzed and authorized.
- In the event of non-conformance, lead analytical investigations, using Root Cause Analysis techniques where appropriate.
- Support the writing of Annual Product Reviews (APRs) on Active Pharmaceutical Ingredients and Laboratory Periodic Review Reports (PRRs).
- Support and participate in self-inspection or other audits
ABOUT THE PERSON:
Education & Work Experience:
- BSc, MSc, or PhD in Chemistry, Microbiology, Biochemistry, Engineering or related discipline
- Technical expertise in analytical / biochemical / microbiological techniques, such as Quantitative PCR, Endotoxin, Bioburden and rapid Bioburden techniques
Candidates must be an EU Citizen or hold a valid work permit/visa to be considered.