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Manager of Bioanalytical Sciences

Company: CyberCoders
Location: San Mateo
Posted on: November 18, 2020

Job Description:

Direct-hire, newly created opening for a Manager of Bioanalytical Sciences with experience with the development and transfer of FDA-regulated assays to GLP laboratories for validation.Top Reasons to Work with Us - Recent, summer 2020 Series B funding of over $75MM. - Targeting multiple serious and life-threatening rare diseases with unmet needs - Work closely with executives and top researchers as we only have - Founders previously built and sold a startup biotech company for over $350 millionWhat You Will Be Doing Reports to: Translational Research Direct reports: None. Collaborate with team of an SRA II and two Associate Scientists. Bench time: None - Advance programs forward from lead candidate selection through IND-enabling studies - Develop and/or validate bioanalytical methods per Health Authority Guidance Documents (cell-based and ligand binding assays) - Manage the successful transfer of multiple assays to contract research laboratories (CROs) capable of supporting GXP non-clinical and clinical studies - Manage outsourced in vivo studies, PK/PD models, and associated bioanalytical assessments - Responsible for data review, analysis, interpretation, and report writing in support of in vitro pharmacology, in vivo pharmacology and/or clinical study regulatory filings - Mentor and train new and junior-level employeesWhat You Need for this Position EDUCATION: - BS/BA, MS/MA, or PhD with relevant experience leading to the ability to perform requirements independently. Likely 10 years' experience for BS/BA, 8 years' for MA/MS, and 3 years' for PhD. REQUIRED: - Strong knowledge of FDA and other regulatory agency requirements for the performance of bioanalytical testing for large molecules PREFERRED: - Development and transfer of FDA-regulated assays to GLP laboratories for validation - Oversight of outsourced in vivo experiments - Managing external vendors like CROs - Contribution to regulatory filings - Protocol development per FDA regulationsWhat's In It for You We offer competitive compensation and pre-IPO stock options along with generous benefits including medical, dental, vision, 401K, unlimited PTO, holidays, and moreSo, if you are a Manager of Bioanalytical Sciences with experience, please apply today

Keywords: CyberCoders, San Mateo , Manager of Bioanalytical Sciences, Other , San Mateo, California

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