North America-United States-Wisconsin-Middleton - Research Way
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.
Under moderate supervision, the Scientist's primary responsibilities involve supporting the design and conduct 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.
Education and Experience:
BS/BA in cell biology or immunology or related field with 2 years experience in analytical testing laboratory or
Associates degree in laboratory science with 6 years of hands on laboratory experience or
Non-degreed with 8 years of hands on Pharmaceutical laboratory experience
Or equivalent years experience in lieu of education
- Direct hands-on experience in quantitative and qualitative analysis using immunochemistry or cell based assay techniques is expected
- Strong foundation of knowledge in biological sciences and good aseptic technique is essential
- Ability to apply analytical methods to meet international system suitability expectations is desired
- Experience training junior scientists is desired
- Good verbal and written communication skills is desired
Pharmaceutical Product Development, Inc. - 14 months ago