Research Scientist, Analytical Operations
Research 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. 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
Research Scientist, Analytical Operations - Foster City, CA
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
- Manages method validation and transfer for late stage development and commercial products based on polypeptides, biologics and small molecules
- Plans, designs and implements laboratory experimentation for method validation and method transfer
- Authors reports, protocols, test methods, and other documentation
- Serves as Subject Matter Expert on analytical techniques (e.g., cell-based or ELISA based functional assays, cell binding or cytotoxicity assay, impurity assessment, separation technology-based method such as SE-UPLC, CE-SDS, cIEF etc.) used in analysis and characterization of therapeutic biologics and/or antibody-drug conjugates (ADCs); experience with other analytical techniques including RPLC, dissolution, Karl-Fischer, GC, particle characterization and spectroscopy is desired.
- Troubleshoots complex failures/investigations effectively and efficiently
- Provides guidance to junior team members on experimental design, data interpretation and troubleshooting failures/investigations
- Supports local and global regulatory filings (IND/IMPD, NDA/BLA, etc.) with regard to analytical method validation and transfer
- May support regulatory responses to questions related to methods and validation
- Manages multiple projects, works closely with internal customers, CMOs and external vendors/contractors to ensure analytical deliverables are met per the project timelines
- Participates in or leads cross-functional project teams
- Provides the highest quality analytical support, meets aggressive timelines while ensuring compliance to SOPs, protocols, cGMPs and safety regulations
- Works on a wide range of problems where analysis of situations or data requires evaluation of intangible variables, requiring regular use of ingenuity and creativity
- Serves as a key member of the Gilead team in the contract lab qualification and requalification process
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work
- Excellent scientific and business communication skills (both verbal and written) are required
- Excellent interpersonal skills are required
Experience & Skills:
- Industry experience preferred
- Hands on experience with development, validation and transfer of analytical methods for therapeutic biologics and/or antibody-drug conjugates (ADCs)
- Hands on experience with standard microbiological techniques, including aseptic technique, bioburden testing, bacterial endotoxin testing and general microbiological techniques
- Experience with authoring of relevant sections of IND/IMPD, BLA and MAA filings preferred
- Knowledge of industry guidance documents (ICH, USP, Ph. Eur, etc.) highly desirable
- Ability to think critically and creatively, determine appropriate resources for resolution of problems and have strong organizational and planning skills
- PhD with Post Doc in biological sciences or chemistry
- BS or MS degree in biological sciences or chemistry with extensive industry experience
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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 firstname.lastname@example.org for assistance.
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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