Sr. Research Scientist II, Bioanalytical Chemistry
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
At Gilead, a Senior Research 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.
Specific Responsibilities and Skills for the Position:
- For protein therapeutics (e.g., antibodies, fusion proteins), provide scientific oversight to partner CROs for development and validation of bioanalytical methods (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.
- Prepare 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.
Knowledge, Experience, and Skills:
- Oversee bioanalytical method development, method validation, and sample analysis for protein therapeutics (including PK, ADA and NAb) 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.
- Review/approve CRO bioanalytical study plans and reports to ensure compliance with appropriate best practices, SOPs and regulatory guidelines.
- Author bioanalytical sections of Clinical Study Reports, and provide input to regulatory documents/questions as needed.
- 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 for the bioanalytical work; monitor material usage.
- Author/review relevant sections of clinical study protocols and lab manuals to ensure clinical study samples are collected and analyzed appropriately.
- BS, with 13 years of experience, MS, with 11 years of experience or PhD, with 6 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 biochemistry, including macromolecule structures, functions and interactions.
- Knowledge of techniques associated with collection and analysis of biological samples for analytes of interest using immunoassay techniques such as ELISA, ECL, Gyros, etc. Knowledge of applicable chromatography and mass spectrometric techniques is a preference.
- Knowledge of immunogenicity and recent regulatory guidelines on immunogenicity method requirements.
- 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, working independently and ability to coordinate and collaborate within a department, across internal company groups, and with external partners.
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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 firstname.lastname@example.org
for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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