Analytical Chemist

Responsibilities

• 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.