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SCIENTIST II/SR. SCIENTIST I, ANALYTICAL TECHNOLOGIES

Company: Gritstone Oncology
Location: Pleasanton
Posted on: May 3, 2021

Job Description:

Description Position Summary:The Scientist/Sr. Scientist will execute activities associated with the development, optimization and qualification/validation of analytical methods in support of all Gritstone drug product manufacturing processes. This role will need to liaise with research, production, engineering and process development to foster effective communication, technology transfer and achievement of corporate goals between groups. Responsibilities:Actively contribute to the successful development, qualification and execution of robust analytical methods in support of company pipeline projectsPerform analytical procedures in support of characterization, lot release and stability testing of drug substance and drug productsProvide analytical support for IND-enabling process development and manufacturing operations, including qualification and tech transfer of in-process methodsEvaluate/select new technologies, instruments, reagents and perform necessary qualificationsEnsure high-quality and timely documentation in laboratory notebook and development reportsDraft and review SOPs, test records/forms, various analytical protocols and reportsAnalyze/summarize experimental data and present findings to scientists and management at technical and project sub-team meetingsWork closely with Project Management, Regulatory Affairs and Quality to ensure project and regulatory filling timelines are metManage activities at contract manufacturing organizations (CMO) and contract testing labs (CTL), including review and/or approval of test records/forms, protocols and reports, deviations/investigations, standard operating procedures (SOP) and certificates of analysis (COA)Perform other duties as assigned, such as lab maintenance, technology evaluation, equipment purchases and qualifications, order and stock lab supplies, etc.Qualifications:The ideal candidate for this position will have demonstrated in-depth experience with hands-on execution and management of analytical development/QC function associated with the GMP production and testing of biologics in an industry setting.PhD in Biological Sciences or related scientific discipline3+ (Scientist II level), or 6+ (Sr. Scientist level) Biotech/Pharmaceutical industry experience, with a primary focus on analytical development of biologics requiredExperience in vaccine, RNA analytical method development and optimization desiredExperience in analytical method qualification, validation and technology transfer to QC lab desiredKnowledge of product and process development of biologics/vaccines desiredKnowledge of GMP and FDA/EMA/ICH/USP regulatory requirements desiredKnowledge of product and method comparability studies, CQA studies desiredGood laboratory practice is a mustMust have hands-on method development/optimization/qualification/validation experience in at least 2 of the following areas:Molecular Biology based method, such as qPCR, NGS, cloning, etc.Virological methods, such as infectivity, RCA, Adventitious virus assays, etc.Immuno- or Biological-based methods, such as ELISA, potency assay, etc.Biophysical characterization methods for biologics, such as virus, RNA, lipid nanoparticles, bispecific Abs, etc.Analytical Instrumentation methods, such as HPLC/UPLC, Mass Spec, etc.

Keywords: Gritstone Oncology, Pleasanton , SCIENTIST II/SR. SCIENTIST I, ANALYTICAL TECHNOLOGIES, Other , Pleasanton, California

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