Scientist, Pivotal Biologics - Analytical Operations

At Gilead, were creating a healthier world for all people. For more than 35 years, weve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Job Responsibilities

• Proficiently executes laboratory techniques such as ELISA, DNA, beta-glucan and other plate-based assays commonly used for biologics.
• Designs process-specific host cell protein ELISAs, including generation of custom reagents, method development, qualification, validation, bridging and coverage assessment.
• Designs critical reagent strategies for process-specific host cell protein ELISAs.
• Authors analytical test methods, study protocols, technical reports, and contributes to regulatory filings.
• Acts as analytical method owner for assigned assays by developing a deep understanding of method attributes and performance through execution and/or review of robustness experiments and method monitoring in preparation for commercialization.
• Presents findings to cross functional internal/external teams.
• Contributes to late-stage method validation activities internally and at external laboratories.
• Independently plans and executes assigned experiments to support method development activities and non-routine investigations to deliver on project goals.
• Trains and mentors junior scientists or direct members of project teams in the initiation and execution of experimental plans.
• Thinks critically and creatively, works independently as well as a part of collaborative teams.
• Has strong organizational and planning skills.
• Cultivates a culture that embraces scientific excellence, urgency, partnerships with key stakeholders, continuous learning and improvement, taking proactive role in personal growth and development.

Basic Qualifications

Ph.D. with 0+ years of relevant experience; OR

MS with 4+ years of relevant experience; OR

BS with 6+ years of relevant experience.

Preferred Qualifications

• Understands the analytical life cycle concepts as applied to analytical development.
• Familiar with FDA and ICH guidelines relating to analytical procedure development and validation.
• Demonstrated skills in analytical instrumentation and data analysis.
• 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.
• Practical working knowledge of cGMP is desired; capable of assessing compliance to quality requirements 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, including plate-based assays (e.g., ELISA), and DNA.
• Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
• 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.
• Supervisory experience is desired.

The salary range for this position is: $133,195.00 - $172,370.00. 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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