Scientist - Cellular Bioassay
Cellular Scientist role available with a successful pharmaceutical company in the midlands.
the Scientist's primary responsibilities involve supporting the design, conduct and oversight of development projects to create and validate new bioassay methods, enhancing existing methods, and transferring client-provided methods.
Additional responsibilities may include consulting with clients, training of junior scientists, troubleshooting of instruments and method performance, and preparing technical reports and papers.Cell-based assays, or bioassays, are designed to establish the potency and stability of a drug substance/product.
Potency assays are necessary for regulatory submission and lot release, and must be validated to meet international guidelines and under GMP quality system compliance.
This is expected to be completed under limited supervision.
Qualifications & Experience
Minimum three years industry expereince.
Ph.D. in microbiology, immunology or cell biology and experience in developing cellular and immunologically based assays; or equivalent cumulative experience with a lesser degree.
Knowledge, Skills and Abilities:
Direct hands-on experience in quantitative and qualitative analysis using immunochemistry or cell based assay techniques is required.
Strong foundation of knowledge in biological sciences and good aseptic technique is essential.
Ability to develop analytical methods to meet international system suitability expectations is desired.
Experience training junior scientists is desired.
Working knowledge of ICH and USP guidelines and FDA GMP regulatory requirements is desired.
Good verbal and written communication skills are expected.
Kevin Silke | Tel: +353 (0) 1 5079255