Senior Technical Specialist - Bioassay
Full time
at Life Science Recruitment
in
Ireland
Posted on September 13, 2024
Job details
Senior Technical Specialist - Bioassay RK2194611 Months Cork We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This is a position requiring someone with strong Analytical experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team and commercial testing laboratories. Duties:
- Good knowledge of working practices required for working in a Bioassay laboratory (e.g. ELISA, cell biology, cell culture, protein biochemistry etc.)
- Support assay optimisation/investigations within the Bioassay area
- Analytical 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 using project management tools.
- Lead cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other Sites within the network and contract laboratories as required.
- Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and lifecycle management of Bioassays.
- Engage in ongoing Bioassay performance 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.
- BSc in a relevant Science discipline
- Experience with ELISA/Bioassays and leading analytical method validations
- Project management or qualifications such as Project Management Professional (PMP)
- Ph.D./M.Sc. qualification (Science)
- Knowledge of and experience in applying Six Sigma and Lean methodologies
- Equipment commissioning and qualification.
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