Job Description 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.
Will execute and analyze experiments with some oversight that lead to the development of robust analytical methods.
Developing highly impactful methods, including QC methods for lot release and stability testing and 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.
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. Skills: Qualifications
B.S. with 3 - 5 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.).
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.
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.