Associate Microbiology Manager role available with a global biotech based in Limerick
Associate Manager QC Microbiology
Excellent opportunity to join a world class team based in Limerick. This biotech is continuing to grow and expand during these difficult times and I have no doubt that it will continue to thrive over the coming years.
This role offers a senior candidate, who may or may not have people management experience, the chance to grow and develop in one of the most well renowned pharmaceuticals in the world.
Summary: Oversees the laboratory quality control testing of in-process samples, sampling of utilities and manages the environmental monitoring programme.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Manage a team of laboratory analysts within the QC microbiology department involved in the analysis of intermediates (in process) and bulk drug substance in a cGMP regulatory environment. Distribute work load and monitor progress.
* Manage the environmental monitoring programme, including surface, settling and viable and non-viable particulate air monitoring of aseptic operations and controlled areas
* Manages product testing to ensure efficient and compliant operations.
* Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
* Review and approve method protocols, reports and SOPs.
* Assist in the preparation for internal/customer/regulatory inspections.
* Ensure a safe working environment within the laboratory.
* Proactively identify and implement lab process improvements, lean initiatives.
* Oversee or conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT.
* Ensure that CAPAs and Change Controls are initiated and completed on time and in accordance with site procedures.
* Present analytical data reports clearly and concisely to senior management, including QC performance metrics and trends.
* Ability to train, develop and mentor direct reports and effectively manage the performance of individuals.
Education and Experience:
* Requires BS/BA in Life Sciences or related field with 6+ years of relevant experience, preferably in the pharmaceutical or biotechnology industry.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.