Analytical Technology Specialist (Bioassay)

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2022-03-31 10:34:481970-01-01Team Horizon
Job TypePermanent
Start Date
AdvertiserMary King
Job Ref2422
Job Views208
We are seeking applications for an Analytical Technology Specialistfor our client who is a leading pharmaceutical company based in Mayo.As an Analytical Technology Specialist, you will support the operations of the Bioassay Laboratory conducting Cell-Based Potency Assay (CBPA) testing of product release, stability and investigation lots. With an exciting pipeline of products and a great salary and benefits package, this may be the ideal opportunity to develop your career with an industry leader.
What you will be doing:
  • Complete writeups on time and participate in the review of team analytical work. Conduct validation testing for key projects in the Bioassay group.
  • Generate validation documentation, update SOPs, oversee the progression of key validation projects within the Bioassay group, JMP analysis, generate toxin trends, qualification of critical reagents and perform lab duty tasks as required.
  • CBPA analysis of release, stability and investigational analytical activities.
  • Support and execute Method Transfer and Validation activities associated with key biological drug product projects.
  • Compiling and review of Laboratory documentation (e.g. SOPs, methods, validation documentation etc.).
  • Support regulatory inspections as required.
  • Perform lab duty tasks to maintain a high standard of housekeeping within the laboratory.
  • Drive Root Cause Analysis investigations.
  • Support and lead Laboratory projects to ensure timelines are met successfully.
  • Manage group activities as required and lead projects to ensure completion.
  • Participate at meetings and provide input to key projects and improvements within the group.
What you need to apply:
  • You will have a 3rd level qualification in a relevant science discipline with master or PHD preferred.
  • Knowledge of biologics manufacturing, bioassays, biochemistry, biostatistics and experience within a GMP testing laboratory.
  • A clear understanding of working within a regulated environment.
  • Excellent communication and presentations skills, both written and oral.
  • Strong analytical skills with the ability to plan and schedule workloads.
  • Drive, high energy, maturity, and ability to work under pressure and deliver results
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