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Sr. Research Scientist I Bioanalytical Chemistry

Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: May 3, 2021

Job Description:

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.**For Current Gilead Employees and Contractors:**Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld) to apply for this job.**Job Description**At Gilead, a Senior Scientist in Bioanalytical Chemistry department will have responsibility and accountability for bioanalytical programs. You will have unparalleled opportunity to be involved with several aspects of the product development process. From first-in-human through approval and post-marketing activities, you will provide input into a breadth of products across therapeutic areas. We seek to provide a rewarding career and a continuous learning experience.+ For protein therapeutics (e.g., antibodies, fusion proteins), provide scientific oversight to partner CROs for development and validation of bioanalytical methods in biological fluids (serum, plasma, etc), such as drug concentrations, anti-drug antibodies, and neutralizing antibodies, analysis of clinical study samples, and reporting of results in compliance with scientific principles and global regulatory standards.+ Assist in preparation bioanalytical sections of clinical and regulatory submission and response documents.+ Coordinate with other Gilead groups to manage the synthesis, characterization, and supply of reference materials, critical reagents, and related materials required by CROs to conduct regulated bioanalytical work, particularly for protein therapeutics.**Specific Responsibilities and Skills for the Position:**+ Oversee bioanalytical method development (serum, plasma, etc), method validation, and biological sample analysis for protein therapeutics at CROs in line with scientific principles and global regulatory standards for quality and compliance, including applicable GxP principles. Assist/facilitate resolution of assay method and sample analysis issues.+ Draft/Review/approve bioanalytical study plans and reports to ensure compliance with appropriate SOPs and regulatory guidelines.+ Draft/Author bioanalytical sections of Clinical Study Reports, and to regulatory documents.+ Write and/or review bioanalytical SOPs and related documents and checklists.+ Collaborate with other departments and external providers to ensure synthesis and availability of appropriate materials for use at CROs; monitor material usage.+ Draft/author/review relevant sections of clinical study protocols and lab manuals to ensure clinical study samples are collected and analyzed appropriately.**Knowledge, Experience, and Skills:**+ BS, with 10 years of experience, MS, with 8 years of experience or PhD, with 2 years of experience in the development and/or application of bioanalytical assays for protein therapeutics. An equivalent combination of related education and required relevant work experience will be considered.+ Knowledge of basic chemistry, including molecular formulas and elemental isotopes.+ Knowledge of techniques associated with collection and analysis of biological samples for analytes of interest using immunoassay techniques. Knowledge of applicable chromatography and mass spectrometric techniques is a preference.+ Technical understanding of bioanalytical operations, including sample analysis strategies, instrumentation, and general laboratory operations.+ Basic understanding of factors affecting the precision, accuracy, and reliability of bioanalytical assays, including the mathematical treatment of data from such methods.+ Good communication skills (document authorship, email, verbal).+ Organization, project management, negotiating skills, and ability to coordinate and collaborate within a department, across internal company groups, and with external partners.**For jobs in the United States:**As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.For more information about equal employment opportunity protections, please view the EEO is the Law (http://www.eeoc.gov/employers/upload/poster_screen_reader_optimized.pdf) poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.**For Current Gilead Employees and Contractors:**Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhEKBggDEMenAhIHCgUI1A0QcQ~~/cacheable-task/2997$2151.htmld) to apply for this job.Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Keywords: Gilead Sciences, Inc., San Mateo , Sr. Research Scientist I Bioanalytical Chemistry, Other , San Mateo, California

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