This job requires someone with strong Microbiology experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team and commercial testing laboratories. The successful candidate will be responsible for leading the effective and efficient running of Microbiology Projects both globally and locally, Analytical Method Transfers, Validations, Verifications, Investigations and Change Control.
- The successful candidate will be a member of the Analytical Sciences Leadership team governing the Analytic Sciences group with the following responsibilities.
- The Senior Microbiology Technical Specialist will support assay optimisation/investigations within the Microbiology area - Technology Transfer - Preparation of documentation associated with the projects in accordance with GDP
- You will lead the delivery of projects whilst adhering to project timelines through the use of project management tools
- This job will involve leading cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other sites and contract laboratories as required.
- You will be responsible for commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and ongoing monitoring.
- The Senior Microbiology Technical Specialist will 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
The next Senior Microbiology Technical Specialist will have a BSc in a relevant Science discipline with extensive experience leading analytical method validations/Verifications such as Bioburden, Endotoxin and Sterility. You should be self-motivated with a desire to develop yourself and colleagues while working on projects.
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