Sr. Research Scientist I, Analytical Operations
Sr. Research Scientist I, Analytical Operations
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
- Lead and serve on analytical teams supporting clinical development of drug candidates for solid dosage forms and/or parenteral products
- Represent Analytical Core Team (ACT) on cross-functional CMC and project teams and partner with Process Chemistry, Formulations & Process Development, Quality Assurance, Regulatory, and other groups within Analytical Operations
- Participate in departmental activities and improvements. Leadership in this area is also encouraged
- Lead teams and participate in developing analytical specifications and providing strategies for supporting pre-clinical and clinical small molecule process development and manufacturing, and in preparing, gaining buy-in for content, and presenting high quality scientific/technical presentations to peers, departmental management and cross-functional teammates or stakeholders
- Lead staff and teams reporting within our Foster City facility and outside of our organization, i.e., at a contract test lab (CTL) or contract manufacturing organization (CMO)
- Serve as SME, manage and provide technical and scientific leadership to a highly technical analytical method development team, including but not limit to:
- Physical and chemical characterization of drug substances, drug substance starting materials and intermediates, and drug products using techniques including HPLC, UPLC, GC, dissolution, particle characterization, Xray diffraction, thermal analysis, microscopy, and spectroscopy, to support process development, control strategy, or to achieve specific analytical goals
- Keeping abreast of new technologies and collaborating with internal and external organizations
- Providing technical and regulatory support to drug substance and drug product development, including impurity control strategies and process route development
- Employ data-driven approach to devise strategies
- Generating, reviewing, and approving necessary reports to provide scientifically sound and data-based support of product development, knowledge management, and data traceability.
- Lead and provide guidance in method validation and transfer to other Gilead sites and CTLs/CMOs
- Provide the highest quality analytical support, meet ambitious timelines and comply to SOPs, protocols, cGMPs and safety regulations
- Support quality investigations and resolution through collaboration with manufacturing and quality to design meaningful hypothesis testing plans
Essential Education, Experience & Skills:
- PhD with 2+ years of industry experience in Chemistry (or another related science) or MS with 8+ years, OR BS with 10+ pharmaceutical industry experience.
- Familiar with relevant regulatory guidance (e.g., USP, ICH, CFR) and apply in daily work and strategy
- Think independently while working in a team environment
- Detail-oriented while understanding the CMC overall business needs
- Must be a critical and creative thinker in order to identify and improve inefficiencies
- Excellent written and verbal communication skills required
- Strong desire to work in a collaborative and multi-disciplinary environment, learning new skills, and proactively solving problems
- Prior people management experience viewed positively
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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' 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:
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Research-Scientist-I--Analytical-Operations_R0020371-2
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