Senior Research Scientist I, Bioanalytical Chemistry

Senior Research 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. Gilead's 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 company's five core values. That's 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

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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Senior Research Scientist I, Bioanalytical Chemistry:

POSITION OVERVIEW:

With increasing independence, you will typically develop and execute bioanalytical plans for bioanalytical method development, method validation, and clinical study sample analyses, which range from first-in human through approval and post-marketing activities and are generally conducted through contract research laboratories (CROs), ensuring overall compliance with GLP/GCP regulations to support Gilead's clinical programs. Working in collaboration with others, you are responsible for various aspects of bioanalytical program activities. These activities include, but are not limited to, collaboration on functional area activities during program implementation, bioanalytical design and input into clinical study protocols, bioanalytical method development, method validation, sample analysis, guidance and coordination with internal cross-functional partners and CROs, and bioanalytical input into clinical study reporting and regulatory filings. You will typically play a lead scientific role, which will entail coordinating and providing direction to internal and external partners involved in bioanalytical design and execution. You will deliver new scientific or technological ideas that advance our progress.

EXAMPLE RESPONSIBILITIES:
Provides input into product development strategies and/or research or clinical development plans for assigned products / projects.Typically leads and manages design and conduct of bioanalytical activities of moderate complexity, which typically includes responsibilities for acting as a member of the respective cross-functional study team.Provides bioanalytical input into clinical study protocols.Works with cross-functional partners and CROs to implement and monitor bioanalytical activities. Coordinates with cross-functional partners to manage lifecycle planning and implementation for methods and materials required to conduct regulated bioanalytical work at CROs. Addresses issues arising from bioanalytical activities, including resolution of assay methods and sample analysis issues.Provides scientific oversight of bioanalytical method development, validation, sample analyses and reporting at CROs in-line with scientific principles and global regulatory standards.Provides bioanalytical input into study documentation, data analysis / management plans and scientific presentations or literature.Manages timelines and resources to ensure timely and accurate execution of bioanalytical activities.Presents project updates and other key milestone information to cross-functional partners and stakeholders.Anticipates problems that may arise in clinical studies and develops solutions for these using precedents, collaboration and original thinking.Develops bioanalytical inputs into regulatory documentation that may serve for submission in regulatory filings.May participate in the authoring and / or implementation of bioanalytical SOPs and related documentation.Provides matrix management and leadership to projects supported.Adheres to regulatory requirements of study conduct, scientific principles, industry standards, and Gilead SOPs.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience
PhD in chemistry, pharmaceutical sciences or related discipline with 2+years' relevant experience in development and / or application of bioanalytical assays methods for drugs in the pharma or biopharma industry, healthcare, consulting, academia or a related environment.MS in chemistry, pharmaceutical sciences or related discipline with 8+ years' relevant bioanalytical assay methods experience.BA/BS in chemistry, pharmaceutical sciences or related discipline with 10+ years' relevant bioanalytical assay methods experience.Experience working with various techniques associated with the collection and analysis of biological samples for analytes.Experience applying global regulatory (GLP/GCP) requirements for bioanalysis of new chemical entities, metabolites, biomarkers, or related substances.Significant experience working on and with cross-functional project / program teams in drug research or development.Multiple years' experience supporting bioanalytical method design and validation, clinical study sample analysis and regulatory filings.Experience supporting scientific publications and presentations is preferred.Consistent success in scientific research in an academic or industry setting.

Knowledge & Other Requirements
Demonstrated ability to be a fast learner.Demonstrated ability to be flexible and adaptable to change in a fast-paced environment, to move between projects easily and provide support/expertise where needed.Proven analytical abilities as demonstrated through past experience and/or academic research.Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.Significant knowledge of drug discovery and development, including study start-up, study management and monitoring, study close-out and reporting.Understands cross-functional roles and responsibilities in the design, conduct and close-out of clinical studies.Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting bioanalytical approaches and techniques.Demonstrates knowledge of how an assigned project fits into the broader strategic goals of the company.Knowledge of basic chemistry, including molecular formulas; protein, RNA and DNA structure and nomenclature; and elemental isotopes.Demonstrates technical understanding of bioanalytical workflows, including sample analysis strategies, instrumentation and general laboratory operations with familiarity of pharmacokinetics in drug development.Demonstrates understanding of factors affecting the precision, accuracy and reliability of bioanalytical assays, including the mathematical / statistical treatment of data from such methods.In-depth bioanalytical knowledge and experience working with analytical instrument platforms, such as LC-MS/MS.Hands-on experience in developing and validation LC-MS/MS bioanalytical methods using various sample preparation techniques.Knowledge of applicable chromatography and mass spectrometric techniques or immunoassay techniques, or both, is preferred.Strong oral and written communication and organizational skills.When needed, ability to travel to perform regular site visits, inspections and audits

The salary range for this position is: $165, $214, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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For Current Gilead Employees and Contractors:

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