Director, Analytical Development

Onsite Required

United States - California - Foster City

Full time

R0056301

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

Job Summary

The Director of Analytical Development leads a team of scientists responsible for defining analytical strategy and execution across our small molecule portfolio, from candidate nomination through commercial approval. The Director will set end-to-end analytical development strategy from raw materials through drug product, ensure phase-appropriate analytical control strategies, method development, and analytical technology development. This role represents Analytical Development on cross-functional CMC teams and governance bodies. This role combines deep technical leadership with people management and business acumen in a fast-paced environment.

Responsibilities

• Lead, mentor, and develop a team of scientists that define end-to-end analytical development strategies (from raw materials through drug product) for Gilead portfolio across pre-clinical, all clinical phases and commercial lifecycle. The control strategies include impurity control (process impurities, degradants, mutagenic impurities per ICH M7, nitrosamines, elemental impurities per ICH Q3D)

• Partner with Research, Regulatory Affairs, Process Chemistry, Formulation, Quality, and Manufacturing to align control strategies with process & product understanding and regulatory expectations

• Drive the development, implementation, and continuous improvement of analytical methodologies and technologies including HPLC/UPLC, GC, dissolution, KF, spectroscopy, particle size, etc. aligned with ICH guidelines and phase-appropriate development needs

-Guide technical transfer to internal QC laboratories and support method development/technical transfer to external partners (CDMOs/CTLs)

-Direct development stability strategy and support GMP stability programs (ICH Q1A–Q1E), including shelf-life setting and stability data interpretation

• Champion modern approaches including analytical QbD (ICH Q14), enhanced method development, and data integrity best practices

-Direct innovation of analytical technologies to improve productivity and increase product and process understanding

• Serve as cross-functional team leader. Participate in governance and technical review committees; contribute to portfolio-level CMC strategy and risk assessment

• Author, review, and approve analytical sections of regulatory submissions (IND/IMPD, NDA/MAA, amendments, responses to health authority questions)

• Represent Analytical Development in health authority interactions and pre-approval/pre-license inspections

-Operate within departmental budget, resource allocation, and prioritization across a multi-program portfolio

• Foster a culture of scientific rigor, quality, inclusion, and continuous improvement

Qualifications

-Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related discipline with 8+ years of relevant experience in pharmaceutical/biotech analytical development with Ph.D., 10+ years with MS and 12+ years with BS.

• 5+ years of people management experience, including directing managers and leading sizeable teams

• Demonstrated expertise in small molecule analytical development and technology innovation across the full development lifecycle, including early and late-stage development & commercial support

• Deep working knowledge of ICH guidelines (Q1, Q2, Q3, Q6A, Q14, M4, M7), cGMP requirements, and global regulatory expectations

• Experience contributing to regulatory submissions (IND/CTA, NDA/MAA) and responding to questions to global health authorities

• Strong cross-functional leadership, oral and written communication skills; able to influence at senior levels in a matrixed organization

• Experience with complex dosage forms (e.g., API, fixed-dose combinations, modified release, sterile injectables) or specialized modalities

-Demonstrate high learning agility and the ability to understand and exploit effective scientific concepts and methods across multiple subject areas (e.g., chemistry, pharmaceutical sciences, PAT, and modeling/ simulation).

• Experience with pre-approval inspections (PAI) and commercial lifecycle management (post-approval changes, ICH Q12)

• Experience building or restructuring analytical organizations; including LIMS/ELN and digital lab initiatives

-Demonstrated strategic thinking and portfolio prioritization; scientific judgment under ambiguity; talent development; stakeholder management; decision-making in cross-functional governance settings; written and verbal communication suitable for executive and regulatory audiences.

The salary range for this position is: $226,185.00 - $292,710.00. 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 [email protected] for assistance.

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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.

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For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.