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Scientist, Bioassays - CMC Analytical DevelopmentSan Francisco, CADirect HireWe are very excited to present a direct hire position for a Scientist role at a clinical stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases.We are seeking an experienced Analytical Development scientist to conduct assay development, technology transfer, qualification/validation, and to provide scientific oversight of the methods at satellite labs and contract testing organizations. The individual will develop cell-based and other biological and functional assays to support biologic therapeutics programs such as antibody therapies, viral vectors, and cell therapies. This role will involve laboratory work, including the design and interpretation of laboratory experiments, as well as providing representation on cross-functional teams, and may include mentor-ship of lab personnel. The Analytical Development Scientist will also provide subject matter expertise for technical visits and agency inspections. Responsibilities will also include authoring reports, white papers, and relevant sections of regulatory filings.RESPONSIBILITIES:t
Assay development, troubleshooting, transfer, and implementation of cell-based and other functional methods for both process characterization and release testing.t
Participate in the design and startup of development and QC laboratoriest
Support method life-cycle activities for analytical methods including assay transfer, design of validation studies, designing assay maintenance programs, and developing assay controls and trending programst
Provide subject matter expertise for assay work conducted at contract organizations and satellite labs, technical reviews and agency inspectionst
Author reports and relevant sections of regulatory filingst
Work cross-functionally to support other areas of the CMC Analytical organization, such as management of contract organizations, stability, raw materials programs, and assay life-cycle management.
Qualifications and Experience :t
Background in biological therapeutics such as antibodies and vaccines is requiredt
Assay development experience in biological assays such as potency methods (including bioassays), ELISA, cellular cytotoxicity, ADCC, ADCP, surface plasmon resonance (SPR)t
Experience in developing and transferring methods for use in Quality Control or other regulated environments, with an understanding.t
Experience in analytical method life-cycle (assay transfer, qualification, validation, and maintenance) is preferredt
Understanding of FDA, ICH, and EP or other regulatory agency guidance associated with analytical methods and assay qualificationt
Technical writing skills and experience authoring development reports, SOPs, regulatory filings, or other documentst
Excellent proficiency in working on cross-functional, collaborative teams
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Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects
EDUCATION:t
BS/MS and 10+ years or PhD and 4+ years of experience in the biotechnology industry is required
For immediate consideration, please email sayn914@kellyservices.comWhy Kelly ® ?With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly ®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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
