Quality Control Scientist - Analytical Development

Description:

Fate Therapeutics is seeking a motivated scientist with flow cytometry or ddPCR assay experience to support Fate’s Quality Control and Manufacturing programs. The successful candidate will execute and analyze experiments to assess the purity, identity, and potency of stem cell-based therapeutics under cGMP environment. Candidates should have experience working with mammalian cell culture, assay development and assay qualification.

This is a full-time position located at our corporate headquarters in San Diego.

Responsibilities:

• Perform flow cytometry, ddPCR and other cell-based assays to support Fate’s clinical programs including testing of samples from ongoing clinical trials and from manufacturing processes

• Optimize, plan and execute qualification and validation of assays for in-process manufacturing and lot release of stem cell derived products

• Perform data analysis, track data trends, and write comprehensive reports of QC activities

• Perform document writing, review, and work within a Quality System for documentation of reports, assay performance and assay results

• Assist manufacturing and process development to coordinate additional QC testing with CROs

• Assist with general management of the laboratory space, equipment, and inventory

Qualifications:

• Ph.D. degree in Biological Sciences or other related field with a minimum 2+ years of laboratory experience in clinical or biopharmaceutical setting or M.S. degree in Biological Sciences or other related field with a minimum of 8+ years of laboratory experience in clinical or biopharmaceutical setting

• Multicolor flow cytometry experience is a must; experience with the BD flow cytometers, BD FACSDiva software and FlowJo are strongly preferred

• Experience working with human blood and blood products using sterile technique, cell culture or other related experience

• Experience with digital droplet PCR (ddPCR) is preferred

• Familiarity with a GLP, GMP, or CLIA laboratory environment

• Highly organized, detail oriented with excellent record keeping abilities, and strong analytical and problem-solving skills

• Knowledge about hematopoietic cell populations is preferred

• Familiarity with FDA, ICH and GMP guidelines is preferred

Working Conditions and Physical Requirements:

• Will require working with cells and cell lines of human and/or animal origin

• Occasional evening and Saturday work will be required

• 100% on-site work at corporate headquarters in San Diego, CA

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.

For consideration send cover letter and resume.