Job Description
Senior Technical Specialist - Bioassay RK21946 11 Months Cork Were 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 Education and Experience : 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) Desired Qualifications/Experience: Ph.D./M.Sc. qualification (Science) Knowledge of and experience in applying Six Sigma and Lean methodologies, Equipment commissioning and qualification. If interested in this posting please feel free to contact Rachel Kent on or for further information. Skills: Bioassay GMP Project Management