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Scientist, Quality Control
2 months ago
Responsibilities Perform GMP IPC, lot release, and stability testing using ddPCR, flow cytometry, and/or cell-based methods.Facilitate and perform method optimization, transfer, qualification, and validation for manufacturing in-process control (IPC), lot release, and stability testing of clinical drug product within a GMP environment. Report results in detailed and organized presentations and reports. Participate in cross-functional training, as well as identifying and facilitating continuous method and process improvements.Manage equipment onboarding activities as needed, including completion of required documentation and managing validation activities. Revise test methods, SOPs, raw material specification, and/or sample plans as appropriate. Participate in lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards. Assist in the implementation of new assay methodologies and the associated instrumentation. Identify and support initiation and completion of deviations, CAPAs, and laboratory investigation.Perform data trending analysis and present findings at cross-functional meetings and contribute to regulatory filing updates. Participate in and prepare for regulatory audits including representing Quality Control in auditor-facing roles as well as supporting lab audit readiness activities. May supervise or mentor junior team members.
Qualifications Ph.D. in Analytical Chemistry, Life Science, Microbiology, Biochemistry, or related discipline with a minimum of 2 years in biotechnology, clinical, or pharmaceutical QC laboratory experience is preferred. Masters degree with 6+ years of relevant and progressive experience may be considered. Experience working in a cGMPP Quality Control lab is required.Experience running ddPCR assays required.Experience running multicolor flow cytometry, with working knowledge of BD flow cytometers, BD FACSDiva software, and FlowJo preferred.Experience working with cell culture, human blood, and blood products using sterile technique. Strong scientific, analytical, problem solving, and communication skills as well as sound judgment, with the ability to work both independently and effectively with others.
Working Conditions Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levelsWill require working with cells and cell lines of human and/or animal originWill require working with hazardous materialsMay require work in controlled and cGMP Manufacturing environments requiring special gowning
The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
CompensationThe salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.The anticipated salary range for this role is $120,000 to $135,000 per year.
