- 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, $286, 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.
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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 to apply for this job.
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Principal Research Scientist I Bioanalytical Chemistry - Foster City, United States - Gilead Sciences, Inc.
Description
Principal Research Scientist I Bioanalytical ChemistryUnited 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
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
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. Join Gilead and help create possible, together.
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:
