Senior Technical Specialist - Bioassay
RK21946
11 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.