Sr. Scientist, Assay Development

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Job description

Kelly Services is currently seeking a Sr. Scientist, Assay Development for a Direct Hire role in San Diego.

Job Title: Sr. Scientist, Assay Development

The company is seeking a Sr. Scientist, Assay Development who will report to the SVP of R&D. This new role will act as an analytical lead for the development, optimization, and maintenance of cell-based assays for cell therapy product candidates. This position will be essential to the overall product development, technology transfer and establishment of Quality Control Operations to support GMP cell therapy production.

Responsibilities include assay development, troubleshooting, tech transfer, validation, and implementation of cell-based and other functional methods for process and product characterization. These assays will include potency, identity, purity, and any other release testing required to ensure consistent production. This individual will generate data and employ innovative methods to develop robust assays that are based on sound scientific rationale and aligned with regulatory requirements and current guidance.

Responsibilities will include:
• Design and conduct essential experiments to develop assays focused on the characterization and functionality of cell therapy candidates, contribute to the understanding of therapeutic critical quality attributes.
• Perform as subject matter expert to conduct assay transfer from R&D group to Quality Control (QC) teams and /or external QC testing labs.
• Work cross-functionally with QC to assist in assay optimization, troubleshooting and validation while implementing assays to support the release, stability and characterization of cell therapy products.
• Support in-process and GMP sample testing, coordination of sample management.
• Analyze and present data in an organized and timely manner.
• Author SOPs, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in IND, BLA, or equivalent regulatory submission.
• Write protocols and execute procedures to support assay qualification and validation efforts.

Education and Experience:
• BS in Biochemistry, Cell Biology, or related scientific discipline and 6+ years relevant experience, or Ph.D. with 2+ years' relevant experience in the biotech / pharma / biologics industry.
• Experience in developing and performing potency and purity assays for biological therapeutics such as viral vectors, vaccines, cell therapy, or antibodies required.
• Experience with mammalian cell culture, understanding of biochemical engineering concepts, and biochemical pathways required.

Total Rewards and Culture
The company, located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, gym membership, and other wellness perks.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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