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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

Principal Scientist in Biologics Analytical Development (Pivotal and Commercial).

United States - California – Oceanside, CA

This role will eventually move to Foster City

Job Description:

The Analytical Operations department is seeking a highly motivated Principal Scientist to lead our rapid testing team. The ideal candidate must possess strong leadership skills to drive the implementation, testing, and iterative improvements for rapid testing, which spans physicochemical, compendial and plate based assays. A strong understanding of regulatory expectations, risk assessment, and the role of rapid testing in biopharmaceutical development is essential. The candidate should be adept at troubleshooting complex assays, interpreting data, and driving innovation in rapid testing to support process development and product characterization.

Responsibilities:

+ Lead a high-throughput testing group to support process development across a wide range of analytical techniques: Chromatographic (SEC, CEX, RPHPLC, HILIC), electrophoretic (CE-SDS, icIEF) and compendial methods (pH, Osmo, subvisible particles, color etc).

+ Manage routine process development and process characterization requests

+ Produce high quality, traceable results (ALCOA) for project team process development

+ Maintain required personnel to support testing, either via internal hires or through in-source contracting models.

+ Implement new technologies to improve throughput/quality of data

+ Implement agility and refinement of submission processes to achieve lean data packages for rapid decision making.

+ Implementing rapid testing capabilities at Gilead Foster City site. The implementation will include instrument set-up/qualification, sample submission process set-up, and personnel hiring/training.

+ Maintaining and managing testing across applicable sites.

+ Accountable for:

+ Defining and managing rapid testing strategies to support process development and process characterization studies, including documentation of data and IQ/OQ commensurate with the level of the data use (e.g. data used to set GMP specifications)

+ Driving continuous improvement of rapid testing to increase throughput and quality of data

+ Support the design/justification/execution of how rapid testing data supports the end-to-end control strategy development through a proactive definition of the product quality targets.

+ Delivering high quality work packages for supporting Pivotal INDa and marketing applications.

+ Serve as an analytical project lead for late-phase program overseeing all analytical deliverables.

+ Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies.

+ Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio.

+ Act as a key member of the extended Analytical Development leadership team to shape late-stage development strategies.

+ Demonstrate comprehensive knowledge in key analytical CMC strategic areas including CQAs, separations methods, method bridging, reference standard, comparability, and specifications.

+ Drive for the adoption of novel and state-of-the-art characterization technologies and approaches.

+ Recruit, hire, and mentor talent to help cultivate a world class Biologics AD organization.

• **Basic Qualifications:**

+ 10+ Years with BSOR

+ 8+ Years with MSOR

+ 5+ Years with PhD/PharmDOR

+ 2+ Years with MD

Preferred Qualifications:

+ Ph.D. with 8+ years or M.S. with 10+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development and/or structural characterization with people leader accountabilities.

+ Significant expertise in rapid testing instrumentation, automation and data processing.

+ Experience with technologies may include but not limited to Mass spectrometry, Analytical ultracentrifugation (AUC), Size exclusion chromatography (SEC), Reversed phase chromatography, Ion exchange chromatography (IEX), Capillary gel electrophoresis (CGE), Light scattering techniques (DLS, MALS) and Molecular analysis.

+ Subject matter expert in establishing comprehensive control strategies for biologics products.

+ Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.

+ Proven track record in drafting regulatory documentation at all stages, including IND, BLA, and PAS filings.

+ Demonstrated ability of building strong collaborations with other CMC functions.

+ Strong business acumen, with ability to balance resource, budget, and program milestones.

+ Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection.

+ Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.

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: $177,905.00 - $230,230.00. 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.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)

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.

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.