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Senior Microbiologist

Quality & Laboratory
Cork
Siobhán Lane
Permanent
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Job Reference: JO-1910-64811_1571391009

Summary:

The successful candidate will be required to demonstrate a high level of technical leadership, collaboration, and coaching to facilitate the team in becoming a high-performance organisation and ensuring timely delivery of projects.


Central to this objective will be the active engagement and communication with all internal and external stakeholders.


A high level of innovation, enthusiasm and drive will be required to deliver technical excellence for analytical method stabilisation and process optimisation studies which will deliver and maintain process robustness.



Responsibilities:


* Good knowledge of working practices required for working in a Microbiology laboratory (e.g. Bioburden, Endotoxin, Sterility testing etc.)


* Support assay optimisation/investigations within the Microbiology area


* Technology Transfer


* Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.


* Lead the delivery of projects whilst adhering to project timelines through the use of project management tools


* Lead cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other Sites and contract laboratories as required.


* Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and ongoing monitoring.


* Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.


* Actively pursue development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc


* Collaborate with internal partners (i.e. other sites, R&D) and externally with CROs Qualifications



Requirements:


* BSc in a relevant Science discipline Ph.D./M.Sc. qualification (Science)


* Experience with leading analytical method validations/Verifications


* Self-motivated and ability to work as part of a team with good project management Skills


* High level written and verbal communications with advanced PC skills


* Knowledge and experience of operating in a development and commercial lab environment.


* Knowledge of and experience in applying Six Sigma and Lean methodologies


* Equipment commissioning and qualification.


* Management Professional (PMP) Evidence of Continuous Professional Development.



Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


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Talent Consultant:
Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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