Senior Scientist, Analytical Development

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 DescriptionAs a Senior Scientist, Analytical Development, you'll play a key role in advancing innovative biologic therapies from discovery through early clinical development, helping bring potential new medicines to patients. In this highly collaborative role, you'll drive analytical development strategies for biologic drug substance and drug product, including molecular characterization, analytical method development, control strategy design, and regulatory support. Working closely with scientists and cross-functional partners across Research, Development, and Manufacturing, you'll tackle complex scientific challenges, advance analytical innovation, and support the development of novel therapies. This is an opportunity to apply your expertise, shape key development decisions, and contribute to a team united by a shared purpose: improving lives through transformative medicines.This position is based in Foster City, CA, and requires onsite work five days per week.As a Senior Scientist, Analytical Development at Gilead you will...Key Responsibilities:Lead analytical activities for pre-pivotal Phase I and Phase II biologic molecules.Identify molecule-specific critical quality attributes and propose and justify analytical control strategies for biologic drug substance and drug product.Author relevant sections of regulatory submissions for biologic drug substance and drug product.Develop analytical methods for molecule characterization and release testing.Author method development reports, test procedures, validation protocols, and validation reports.Oversee internal and outsourced testing, provide guidance on data generation and data integrity, and ensure compliance and analytical excellence at contract organizations.Proactively evaluate and implement state-of-the-art technologies and automation to drive innovation in analytical development and testing.Build and maintain strong relationships with key stakeholders and provide technical and strategic input to colleagues across Research, Clinical Development, Clinical Supply Management, and Program Strategy.Provide technical support for internal and external current Good Manufacturing Practice (cGMP) manufacturing operations.Present research findings and recommendations to senior staff; prepare research reports and peer-reviewed manuscripts; and author or contribute to investigational new drug applications and patent filings.Basic Qualifications:Bachelor’s degree and 8+ years of relevant experienceORMaster’s degree and 6+ years of relevant experienceORPhD and 0+ years of relevant experiencePreferred Qualifications:Biologics-relevant analytical development experience in the biotechnology or pharmaceutical industry.Experience supporting Chemistry, Manufacturing, and Controls (CMC) activities and Phase I investigational new drug applications for biologic products, including IND support or authoring.Strong physical and chemical analytical expertise applicable to biologics, including hands-on laboratory experience with separation-based methods such as UPLC/HPLC, CE-SDS, size-exclusion chromatography (SEC), iCIEF, LC-MS/MS, intact mass analysis, and related separation chemistries.Experience developing, validating, and implementing analytical methods, laboratory automation, control strategies, and analytical development control systems for biologic products from late-stage research through Phase I and Phase II development.Experience overseeing analytical work performed by contract development and manufacturing organizations (CDMOs), including data generation, data integrity, and compliance.Working knowledge of current Good Manufacturing Practice (cGMP) requirements and applicable FDA and ICH guidance for biologic drug substance and drug product.Working knowledge of computer system validation, data governance, data science, knowledge management, and data protection.Demonstrated initiative, creativity, innovation, curiosity, intellectual humility, and a collaborative approach to scientific problem-solving.Strong written and verbal communication skills, with the ability to present scientific findings and provide technical and strategic input to cross-functional internal and external teams.Ability to work independently with limited guidance, manage competing priorities, and contribute effectively in a fast-paced team environment.Experience training or providing technical guidance to less experienced colleagues.People Leader Accountabilities:Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.The salary range for this position is: $169,320.00 - $219,120.00. 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: * 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 View email address on click.appcast.io for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTGilead 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.SummaryLocation: United States - California - Foster CityType: Full time