Scientist, Analytical Ops

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s 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 we’re 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   Key Responsibilities:   Extractables &   Leachables   (E&L) Strategy & Execution   Design and execute   extractables and   leachables   (E&L) studies  to support   injectable biological   drug products, container closure systems, and medical devices .   Develop and author   E&L protocols, reports, and risk assessments  in alignment with regulatory expectations.   Evaluate   leachable profiles across stability studies , identifying trends and potential risks.   Analytical Testing & Characterization   Conduct and/or oversee analytical testing using advanced instrumentation, including:   GC-MS, Headspace   and Direct Inject     LC-UV/MS, LC-MS/MS   High-Resolution   Mass Spectrometry (HRMS)   ICP-MS  (elemental impurities)   Identify   and characterize   unknown compounds  using spectral libraries and structure elucidation tools.   Perform   trace-level quantification  of   leachables   and extractables in complex matrices.   Support   contract laboratory oversight , including study design review, execution monitoring, and data verification.   Method Development & Validation   Develop,   optimize , and verify   analytical methods  for E&L testing across complex pharmaceutical matrices.   Implement   screening strategies  for extractables and   leachables   assessments.   Utilize   appropriate sample   preparation techniques, including:   Solid-phase extraction (SPE)   Liquid-liquid extraction (LLE)   Protein precipitation   Apply   semi-quantitative approaches  using surrogate standards and justify analytical uncertainty where authentic standards are unavailable.   Cross-Functional Collaboration   Collaborate with   toxicology teams  to assess patient risk and   establish   Analytical Evaluation Threshold (AET)     Partner with   Device/Packaging, Process Development, and Formulation Development  teams to support product lifecycle activities.   Present findings and recommendations using a   data-driven approach  to inform technical strategy and decision-making.   Documentation & Compliance   Author, review, and approve   technical reports and documentation , ensuring scientific accuracy, data integrity, and traceability.   Ensure compliance with applicable   regulatory guidelines and standards  (USP, FDA, EMA, ICH, PQRI).   Stay current with   emerging technologies and industry trends  and apply advancements to improve analytical capabilities.   Basic Qualifications: BSc  with at least   8 years  of relevant experience   OR   MSc  with at least   6 years  of relevant experience       Preferred Qualifications:   PhD  in Analytical Chemistry, Pharmaceutical Sciences, or a related field with   0+ years  of   experience, Strong   expertise   in   trace-level impurity detection and identification .   Demonstrated experience with   analytical instrumentation  (GC-MS, LC- UV /MS,   HR MS , ICP-MS).   Proven experience with   sample preparation techniques  (SPE, LLE, protein precipitation).   Strong understanding of   structural characterization and compound identification techniques .   Experience with   regulatory submissions and E&L strategy development .   Track record   of   scientific publications and conference presentations .   Excellent   analytical thinking, problem-solving, and troubleshooting skills .   Strong   communication   and presentation skills , with the ability to influence cross-functional stakeholders.   Ability to thrive in a   collaborative, fast-paced environment .     The salary range for this position is: $146,540.00 - $189,640.00. 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*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , 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 ApplicantAccommodations@gilead.com  for assistance. For more information about equal employment opportunity protections, please view the  'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.   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: Please apply via the Internal Career Opportunities portal in Workday.