Marin Metro Area, CA
Optimize, validate, and troubleshoot assays.
Perform biochemical/chemical analyses of samples to support process development, manufacturing investigations, and assay validation samples under cGMP to meet specified timelines.
Maintain lab in inspection ready state
Support lab equipment management
Prepare protocols, summaries and reports for routine and non-routine studies and analytical method validations.
Draft written QC test method SOPs for new assay methods.
Interface with contract facilities and other departments as necessary.
Well-developed laboratory skills for analysis of small molecule and biopharmaceuticals.
Comfort with coordinating the activities of other staff members and other groups.
At least two years in a cGMP laboratory; quality control experience preferred.
Experience in method development, optimization, qualification, validation, transfer.
Experienced with molecular biological and analytical methodologies such as ELISA, Capillary Electrophoresis, HPLC, Activity, Enzyme Kinetics, and Cellular Uptake.
Preferred experience with many of the following: HPLC, UPLC, Spectrophotometers, Plate readers, LIMS, Softmax Pro, Empower.
Knowledgeable and conversant concerning 21CFR, USP, EP, and ICH regulatory guidelines.
B.S./B.A. in science (majors: biology, biochemistry, chemistry or similar) with at least 5 years experience in a relevant functional area, documentation of specialized training relevant to the position, and thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies. M.S. with at least 3 years of experience in a relevant functional area and thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies.