Associate Scientist, Analytical Operations
Gilead Sciences, Inc.
2021-12-03 08:50:44
San Mateo, California, United States
Job type: fulltime
Job industry: Science & Technology
Job description
Associate Scientist, 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. 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
Associate Scientist, Analytical Operations
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines. With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (PDM) workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
This role is in the Analytical Core Team (ACT) within Analytical Operations (AO), based at our headquarters in Foster City, CA. The group is responsible for CMC analytical activities related to the development of Gilead's small molecule drug substances and drug products. The Associate Scientist will develop and execute analytical methods to support analytical and formulation development. The successful candidate will possess a detailed understanding of analytical method development, strong critical thinking skills, and excellent communication skills.
Essential Responsibilities & Skills:
- Develop and execute analytical methods related to solid oral dosage drug product (stability-indicating assay and impurities, discriminatory dissolution, blend and content uniformity, water content) using techniques such as liquid chromatography, Karl-Fischer, dissolution, disintegration to support analytical and formulation development.
- Use computational predictive tools and modelling software to aid method development.
- Conduct studies for method development/evaluation, validation, transfer and verification according to scientific justifications and current regulatory guidance (e.g., ICH, FDA, USP, EP, etc.).
- Plan and execute experiments such as stability studies, process and formulation samples that support development activities and project goals.
- Troubleshoot analytical methods and lab instrumentation.
- Process and interpret data. Present findings and conclusions at group meetings and technical seminars.
- Recommends and explore alternatives, researches new methods and techniques and proactively seek out senior personnel to discuss potential solutions to problems.
- Author technical documents, including validation/transfer/verification protocols and reports, analytical test procedures, technical reports, analytical investigations, and other documentation.
- Collaborate with supervisory personnel and lab analysts to plan experiments, and work cross-functionally with formulation development, analytical method validation, release and stability groups.
- Develop subject matter expertise in an analytical technique and acts as a resource for other employees within the department.
- Use good verbal and written communication skills and interpersonal skills to provide insight into the processes used to achieve results of assigned tasks.
Education & Experience:
- MS degree with 6+ years OR BS degree with 8+ years of relevant biotech/pharmaceutical professional experience. Degrees should be in Analytical Chemistry, Organic Chemistry, Biochemistry, or a related discipline.
- Hands-on experience and problem solving skills with chromatographic techniques (HPLC/UPLC and GC) and dissolution.
- Experience with mass spectrometry preferred.
To apply, please submit resume through our website at
Gilead is an equal opportunity employer.
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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.
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.
For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.
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