- Expiry Date: 19 September 2021
Research Associate to join the Potency & Functional Characterization department within Analytical Development. The successful candidate will help facilitate the development of assays that characterize the biological activity (e.g. metabolism, proliferation, effector function, and vector function) of autologous and allogenic cell therapies which are currently undergoing clinical trials, including CAR T cell products. The Research Associate will be able to execute and analyze experiments with some oversight that lead to the development of robust analytical methods.
The candidate will have the responsibility for developing highly impactful methods, including QC methods for lot release & stability testing as well as extended characterization methods that support process development and comparability assessments. These methods will be used to further understanding of cell therapies, support development of the manufacturing processes, and/or QC release of the drug product. The Research Associate will have hands-on experience in assay development and will be interested in projects requiring close collaboration with other groups, such as discovery research, product sciences, process development, and QC. The Research Associate will be passionate about developing novel medicines, thrive in an intellectually challenging environment, and enjoy collaborating with a team of like minded Scientists.
Execute, analyze, and document experiments to develop cell-based potency methods for lentiviral and AAV vectors
Develop suitable assay acceptance criteria and establish control ranges
Provide updates on a regular basis at the Potency department meeting
Work with internal collaborators to design and conduct method qualification experiments
B.S. with >2 years of experience in the field of Immunology, Cell Biology, or Cancer Biology, preferably in an industry setting
Experience developing and qualifying cell-based assays, ELISAs, or similar technology platforms (e.g. MSD, Luminex, AlphaLISA, etc.).
Experience with cell culture, primary human cells, and cryopreservation.
Proficiency with relative potency methods, Four-Parameter and Five Parameter Logistic Curve Fit models, robustness assessments, establishing system suitability criteria, critical reagent qualification procedures, analyst training, method transfers, and/or method qualification/validation.
Experience with Design of Experiment (DoEs) using JMP or equivalent statistical software.
Experienced with authoring and revising test methods, protocols, and technical reports.
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