Research Scientist, Biologics Analytical Operations, Late-Stage Analytical Development
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 #CreatingPossibleFor Current Gilead Employees and Contractors:
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At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
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.Essential Duties and Job Functions: Lead the development, validation, and implementation of robust analytical methods for mAbs, fusion proteins, ADCs, and related biologics to support drug substance/drug product in-process, release, stability, and extended characterization testing to drive late-stage programs through PC, PPQ, and registration.
Serve as an Analytical development SME in the late-phase and commercial Biologics team, working closely with Analytical Outsourcing, QC, QA and regulatory CMC for CTL technical readiness, change control and quality events and regulatory filings.
Write and/or review method development summary reports, test methods, validation protocols, validation reports, comparability reports, and author regulatory submissions.
Demonstrate expertise and hands-on technical leadership in chromatographic and electrophoretic analytical techniques for the characterization of biologics such a SEC, CE-SDS, cIEF, RP-HPLC, HIC, HILIC, and LC-MS. Lead assay development and troubleshooting activities through DOE based approaches.
Collaborate with upstream, downstream, and formulation teams to deliver manufacturing processes that meet speed, yield, and product quality requirements. Perform critical data review and provide direction for troubleshooting and investigation.
Foster strong teamwork and communication across Biologics Analytical Operations and the site.
Knowledge, Experience and Skills:
Excellent communication skills (verbal and scientific writing) and strong interpersonal skills are required.
Must have practical working knowledge of cGMP; capable of assessing compliance to quality requirements and regulatory guidances using sound judgment and risk management.
Applies the principles and techniques of Analytical Chemistry to biologics development. Strong scientific background in protein chemistry and biologics analytical methods.
Strong knowledge of analytical lifecycle management principles used to establish and evolve the analytical control strategy of therapeutic protein projects using a phase-appropriate approach with focus on PPQ and registration.
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 in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
Must be able to work independently and thinking critically and creatively to prioritize resources to resolve problems. Must have strong organizational and planning skills.
Experience in IND/IMPD and market registrations of biologics in US and EU.
Innovative, proactive, and resourceful; committed to quality and continuous improvement
Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
Ph.D. in Analytical Chemistry, Biological Sciences, Chemical engineering, or Pharmaceutical Sciences
BS or MS degree with extensive industry experience.
Supervisory experience is desired.
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/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.
The salary range for this position is: $136,000.00 - $176,000.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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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 email@example.com for assistance.
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