Stanford, California
About the business:
Pictor specializes in Research and Development, Manufacture and marketing of miniaturized and multiplexed In Vitro Diagnostic (IVD) products and associated instruments. We are offering a permanent position as Assay Development Scientist.
If you are an Assay Development Scientist with a passion for science and innovation, a strong work ethic, a willingness to develop IVD products for better health outcomes, and would like to grow your career, we would love to hear from you.
About the role Job Duties:
The position will report to the R & D Manager and work closely with the R&D, Manufacturing, and Instrument Development teams.
Primary responsibilities for this role include the development of multiplex ELISA assays on Pictor’s diagnostic platform. Key tasks include:
• The development of Multiplex diagnostic ELISAs
• Design, plan and execute project tasks and scientific research independently with minimal supervision
• Evaluating and interpreting data and proposing sound scientific conclusions
• Identifying the problems in development and solutions them by creative inputs and analytical thinking
• Writing protocols and reports
• Performing feasibility, optimization, verification, and validation studies for the new IVD products
• Use of statistical analysis tools to evaluate data
• Develop quality control metrics to monitor product performance
• Risk assessment and root cause analysis
• Assist with manufacturing activities including incoming QC’s, Source plate preparation, product printing
• Comply with the IVDR, FDA Design Controls Policy, and CLSI guidelines for product development
Skills and experience
What you will bring:
• Proven work experience in the development of immunoassays for clinical or bioanalytical settings. Experience of working in multiplex immunoassays will be a plus.
• 7+ Years of relevant career experience
• MSc / BTech in Biochemistry, Biotechnology, or any relevant field in life sciences
• Strong Analytical Skills
• Knowledge of statistics’ software to determine the analytical parameters of an immunoassay.
• Experience in product manufacturing and quality control
• Experience of working in an ISO certified laboratory, preferably ISO13485:2016 or ISO9001:2015 and/or within a GMP environment
• Experience in biomolecular immobilization, conjugation, biochemical methods, Analytical Techniques, and immunoassays development will be a plus.
• Experience in writing and reviewing SOPs, and MBRs
• The ability to work in a fast-paced environment
• Excellent oral and written communication skills
• Quality focused with excellent attention to detail
• A team player with a willingness to learn and a positive attitude
Ready for your next step? We'd love to hear from you.
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