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Principal Scientist I, 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 Director in the 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, antibody-drug conjugates), 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.
- Provide strategic bioanalytical leadership for all phases of clinical development for protein therapeutic programs and participate in strategy implementation.
- Prepare bioanalytical sections of clinical and regulatory documents.
- Coordinate with other Gilead groups to manage lifecycle planning and implementation for methods and materials required to conduct regulated bioanalytical work for protein therapeutics at CROs.
- Manage bioanalytical staff members directly or indirectly for protein therapeutic programs
Specific Responsibilities and Skills for the Position:
- Lead a team of bioanalytical technical and operational experts in support of bioanalytical method development, method validation, and 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.
- Review/approve bioanalytical study plans and reports to ensure compliance with appropriate SOPs and regulatory guidelines.
- Author/review bioanalytical sections of Clinical Study Reports and regulatory submission documents, including sections of m2.7.1 and Integrated Summary of Immunogenicity.
- Write and/or review bioanalytical SOPs and related documents and checklists.
- Generate, coordinate, and implement consistent practices across protein therapeutic programs and CROs; align them appropriately with small molecule program practices.
- Collaborate across Gilead groups and external providers to ensure lifecycle planning for bioanalytical methods and availability of appropriate materials for assay method use at CROs;
- 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 14 years of experience, MS, with 12 years of experience or PhD, with 8 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; protein, RNA and DNA structure and nomenclature; and elemental isotopes.
- Expertise in 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.
- Experience and expertise in the application of global regulatory requirements for bioanalytics of protein therapeutics.
- Technical understanding of bioanalytical work flows, including sample analysis strategies, instrumentation, and general laboratory operations; familiarity with the role of pharmacokinetics in drug development.
- Basic understanding of factors affecting the precision, accuracy, and reliability of bioanalytical assays, including the mathematical/statistical 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.
- Experience and demonstrated success in supervising others.
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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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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:
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