Residual, Ancillary Materials and Protein Characterization group in Cell Therapy Analytical Development is responsible for the development, qualification, and transfer of biochemical and biophysical methods to support raw material and biophysical characterization testing. The primary goal is to develop robust quantitative analytical test methods for analysis of our cell therapy programs process media and drug product to support our cell therapy development programs forward.
Job Description:Primary Responsibilities include:
Perform method development (Identity, strength/quantification, stability, investigational support), of raw material, in-process formulation of media and buffer samples through Chromatography using multiple detectors (UV/Fluorescence/CAD/MALS), Spectroscopic (FT-IR/Raman), Biophysical and Morphological Characterization tools for Particulate Investigational Analysis (FlowCAM/Microscopic/Nanoparticles), GC-FID and Immunoassay tools.
Routine Testing, Development, Qualification of bioanalytical methods in Characterization set-up, to assess the components of raw materials, excipients, formulation media, buffer, and drug product (i.e., Cell Culture Media, Viral Vectors, Cytokines, human and bovine originated materials, etc.) to support the cross-functional groups (QC, in-process development, manufacturing) for regulatory submissions.
Partner with QC raw material, Process Development, Manufacturing, and Analytical Core functions to test samples in Bio Safety Level-2 (BSL-2) lab environment, perform investigational activities and transfer bioanalytical assays.
Ability to efficiently work on several projects simultaneously in a fast-pace environment.
Explore novel technologies that can quantify/characterize the raw materials that may impact effectiveness of critical process media, reagent and buffer components.
Document experiments in an Electronic Lab Notebook (ELN). Author and review technical documents in an electronic document control system (e.g., Veeva Quality Docs).
Present data to peers and in cross-functional meetings.
B.S. with 3 to 5 years of experience (or M.S. with a minimum of 2 years of experience) in industry setting
Development and troubleshoot experience on Waters UPLC with various detectors in an industrial set-up is a must.
Proficient in multiple bioanalytical platform technologies (e.g., UPLC, FT-IR and Raman micro spectroscopy, FlowCAM, GC-FID) and ELISA techniques.
Communicate effectively (oral and written) and efficiently within teams.
Experience troubleshooting of bioanalytical methods and efficient root cause analysis
Experience with UPLC/HPLC, FT-IR, Fluid Imaging techniques, GC-FID bioanalytical platform technologies and method development
Additional Job Requirements:
Position Handles Hazardous Materials