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
- Provide analytical support, meet ambitious timelines and comply to SOPs, protocols, cGMPs and safety regulations
- Develops analytical chemical test methods for small molecule parenteral/ injectable drug products (purity/impurity by LC, particulate matter, bacterial endotoxins, sterility, etc)
- Oversees design and execution of development, in-use, or accelerated stability studies
- Develops physical characterization tests for drug substances for parenteral drug products (thermal analysis, particle size, microscopy, XRPD, rheometry,etc)
- Works cross-functionally with process chemistry, formulations development, method validation, release and stability groups, QA, and regulatory sciences to develop drug candidates
- Provides guidance to junior team members on experimental design and data interpretation
- SME in an analytical technique and acts as a resource for other employees within the department
- Presents results of work, interprets data, and draws conclusions on complex problems using data from multiple sources
- Maintains high level of expertise with scientific literature and applies appropriately to development projects
- Authors specifications, reports, protocols, test methods, and other documentation
- May contribute to scientific literature and conferences or regulatory filings
- Must be flexible to support changes in project priorities and be able to adapt to fast paced working environment
- Must be a critical and creative thinker in order to identify and improve inefficiencies
Essential Education, Skills & Experience:
- Ph.D. in Chemistry (or another related science) with 2+ years, OR an MS with 8+ years of industry experience
- Experience in parenteral drug product development and control strategies, critical quality attributes assessment on API and DP, and authoring/support regulatory filings or response to questions.
- Experience in supporting formulation development of suspension and solution dosage forms, such as design and execute studies for viscosity, density, in-vitro solution/suspension dissolution studies
- Familiar with relevant regulatory guidance (e.g., USP, ICH, CFR) and apply in daily work and strategy
- Team worker who is willing to work either independently or in collaboration with teammates on assignments
- Familiarity of usage of statistical tools is a plus
- Experience in handling lab investigations, OOT, OOS, deviations and CAPA.
- Contract lab oversight experience for method troubleshooting, method validation, method transfer, and release and stability
- Experience in development of complex LC method, particularly for fixed dose combination products containing more than one active ingredient
- Experience in establishing phase appropriate specifications to APIs and DPs supporting parenteral drug development
- Excellent written and verbal communication skills required
- 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.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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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