Senior Research Scientist II, Analytical Operations
United States - California - Oceanside
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
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.Job Description
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.
Gilead Sciences is currently seeking a Senior Research Scientist II in our Analytical Operations group at our Oceanside facility in Southern California. People management experience in industry is key in this role, which will expand our rapidly growing Oceanside team.Senior Research Scientist II, Analytical OperationsSpecific Responsibilities:
- Lead phase-appropriate analytical method development, validation, trending, and transfer to QC laboratories for drug substance and drug product testing.
- Lead the establishment of appropriately robust and reliable GxP analytical methods for QC testing to support manufacturing activities at both internal and external manufacturing organizations. Cultivate excellent working relationship with stakeholders to deliver successful manufacturing campaigns.
- Apply analytical lifecycle management principle for establishment and continuous improvement of analytical control strategy.
- Maintain strong knowledge of GMPs and manage external CTLs and CMOs.
- Lead biologics testing support for process and cell line development, provide strategic leadership to analytical testing services to ensure adequate resources and technologies are in place to support high throughput processing, and accurate and fast delivery of results.
- Collaborate with process and pharmaceutical development to deliver manufacturing processes that meet the speed, yield and product quality requirements of the development programs.
- Perform critical data review and provide directions for troubleshooting and investigation.
- Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and write/review development summary reports and author sections of regulatory submissions.
- Serve as an analytical representative on pharmaceutical development project teams.
- Be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
- Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
- Lead, motivate, and develop the people in their group. Develop talent to deepen strength and increase capabilities, aligning with individual career goals. Foster good team work and communication amongst staff.
- Routinely make decisions affecting direction of project to ensure project timelines are met.
- Direct research associates or members of project teams (as needed) in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
Knowledge, Experience and Skills:
- Must have practical working knowledge of cGMP; capable of assessing compliance to quality requirements using sound judgment and risk management.
- Responsible for conducting scientific research for the development of drug candidates or the research support of marketed drugs.
- Applies the principles and techniques of Analytical Chemistry to biologics development. Strong scientific background in protein chemistry and biologics analytical methods.
- Works under supervision of more senior scientists or scientific directors to advance the development of state-of-the-art techniques to characterize biologics.
- Advises Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
- Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
- Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company interests.
- Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
- Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
- May make contributions to scientific literature and conferences or regulatory filings.
- Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.
- Experience in IND/IMPD and market registrations of biologics in US and EU.
- Innovative, proactive, and resourceful; committed to quality and continuous improvement
- Strong analytical skills and ability to distill key information from various data sources
- 7+ years of experience and PhD in Chemistry.
- BS or MS degree with extensive industry experience.
- Experience in several of the following fields is strongly desired: analytical chemistry, biochemistry, biological mass spectrometry, high performance or ultra-performance liquid chromatography, electrophoretic separations, enzymology, statistics, chemical and biophysical structural elucidation, and bioinformatics
- Good communication skills (both verbal and technical) and interpersonal skills are required. Must be able to work in highly flexible and effective teams.
- Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Demonstrates ability to recognize anomalous and inconsistent results and interpret experimental outcomes. Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/GileadAbout Gilead:
Gilead Sciences, Inc. is a research-based biopharmaceutical 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.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
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