Principal Scientist

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.

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Job Description

We are seeking a talented and highly motivated Principal Scientist for our Pivotal and Commercial Biologics Characterization team in Biologics Pivotal and Commercial Analytical Development. Broad experience in analytical development from early development to commercial launch filing experience with FDA/EMA and in-depth technology understanding for biological products are the key in this role. A solid understanding of GMPs and CMC requirements is expected.

Responsibilities:

• Provide leadership to a group of scientists focused on glycosylation methods and biological function understanding including:

• Mentor and guide scientists in their roles.

• Set clear expectations and prioritize work packages.

• Recruit and hire new talent.

• Accountable for:

• Defining glycosylation methods and control strategy across the late-phase biologics portfolio and building deep understanding of how this relates to biological function.

• Driving proactive and continuous improvement of glycosylation control strategies and functional understanding.

• Serving as the business process owner for comparability packages from Pivotal to Commercial.

• Support the design/justification/execution of 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 (ASTL) 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.

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 mass spectrometry and higher order structure techniques commonly used for biologics structural characterization.

• Experience with technologies may include but not limited to Liquid Chromatography with Fluorescence or Mass Spectrometry Hydrophobic interaction (HILIC) chromatography Total sialic acid (TSA) Size exclusion chromatography (SEC) Ion exchange chromatography (IEX) Capillary gel electrophoresis (CGE).

• 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.

Create Inclusion - knowing the business value of diverse teams modelling 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 organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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