Principal Research Scientist I Bioanalytical Chemistry

Principal 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.

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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.

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Job Description

Principal Research Scientist I - Bioanalytical Chemistry

This is a site-based position in Foster City, CA

POSITION OVERVIEW:

With considerable independence, you will typically lead development and execution of bioanalytical plans for large and small molecule 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 CROs. 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 be assigned bioanalytical programs of increasing complexity and / or larger scale. 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. You will also assess, identify and recommend state-of-the-art methods for bioanalytical projects.

EXAMPLE RESPONSIBILITIES:

• Routinely provides input into product development strategies and/or research or clinical development plans for assigned products / projects.
• Leads and manages design and conduct of bioanalytical activities for protein therapeutics (including PK, ADA and NAb) of increasing complexity and / or scale, 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, and may lead a small team of internal scientists. 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 bioanalytical input into study documentation, data analysis / management plans and scientific presentations or literature.
• Routinely contributes to scientific literature and conferences through publication and presentation of results.
• 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 and may serve as an authority for documents used in regulatory filings.
• May participate in the authoring and / or implementation of bioanalytical SOPs and related documentation.
• Provides matrix management and leadership to multiple project teams.
• May own and manage the budget and resource plans for assigned area.
• 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 biochemistry, pharmaceutical sciences or related discipline with 8+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 biochemistry, pharmaceutical sciences or related discipline with 10+ years' relevant bioanalytical assay methods experience.
• BA/BS in biochemistry, pharmaceutical sciences or related discipline with 12+ years' relevant bioanalytical assay methods experience.
• Extensive bioanalytical experience or related field with proven success contributing to the scientific strategy for multiple drugs.
• Extensive knowledge of immunogenicity and recent regulatory guidelines on immunogenicity method requirements.
• Extensive experience supporting scientific publications and presentations.
• Demonstrated success in directing and advising other colleagues and/or cross-functional project team members.

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Recognized for sustained scientific excellence.
• Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• Advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
• In-depth knowledge of the multidisciplinary functions involved in drug discovery and development and can proactively integrate multiple perspectives into the bioanalytical process.
• Demonstrable ability to effectively apply business acumen to strategic scientific projects.
• Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting bioanalytical approaches and techniques.
• In-depth knowledge of chemistry, including molecular formulas; protein, RNA and DNA structure and nomenclature; and elemental isotopes.
• Demonstrates and understanding of bioanalytical work flows, 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 available options for mathematical / statistical treatment of data from such methods.
• Knowledge of immunoassay techniques is required, and either applicable chromatography and mass spectrometric techniques or immunoassay techniques, or both, is preferred.
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
• When needed, ability to travel.

The salary range for this position is: $221,170.00 - $286,220.00. Gilead considers a variety of factors when determining base compensation . click apply for full job details