Sr. QC Chemistry Associate I
Core
Performs complex analytical testing, data review, and analysis for in-process, release, and stability assays of proteins, peptides, and small molecules in a GMP-regulated laboratory.
Role type
Senior individual contributor QC Chemistry Associate
Builds
Quality data and reports for biopharma clients
Domain
Biopharmaceuticals / Quality Control Chemistry
Required skills
Complex analytical testing, GMP/GLP compliance, HPLC/cIEF/UV-VIS/Karl Fischer, troubleshooting instrumentation, SOP authoring, root cause analysis, CAPA, LIMS/QMS proficiency
Preferred skills
Bachelor's in Life Sciences, method transfer experience, mentoring junior staff, cross-functional communication
Technologies
HPLC, cIEF, UV-VIS, SoloVPE, viscosity, Karl Fischer, LIMS, QMS, Microsoft Office
Responsibilities
Independently perform routine and complex analytical testing for in-process, release, and stability samples; lead troubleshooting efforts for assays; author and review data packages ensuring cGMP adherence; write, revise, and implement test methods and SOPs; participate in method qualifications, validations, and transfers; mentor and train junior QC staff; investigate and document quality events including OOS results; oversee laboratory equipment maintenance and calibration.
Seniority
Senior, hands-on IC