B.S in Biology, Chemistry, Biotechnology, or equivalent area of related study, with 2-5 yrs. industry experience in biologic/protein analytics or M.S./Ph.D. with 0-5 yrs. experience.
Experience across the analytical method lifecycle in protein Biotherapeutics for a variety of methodologies and instrumentation used in the testing and characterization of raw materials, excipients, in-process, drug substance, and drug product samples including HPLC/UPLC methods and various other analytical techniques (i.e., qPCR, ELISA, CE-SDS, iCIEF, SDS-PAGE, UV-VIS, western blotting, mass spectrometry, and cell-based assays) is preferred.
Working knowledge and experience in the biopharmaceutical development process, GMP, PAT, CMC and regulatory guidance, ICH guidelines, and compendial requirements is desired.
Experience authoring, validating, and coordinating timely transfer of test methods with and to Quality Control laboratories is desired.
Qualifications
Strong written, verbal, presentation and interpersonal communication skills.
Detail oriented with good organization skills.
Ability to prioritize, independently manage and complete deliverables within given timelines.
Ability to problem solve and apply risk-based critical thinking in a technical environment.
Demonstrated history of continuous improvement is desired.