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.

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

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.

The salary range for this position is : $177905.00 - $230230.00. 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 disabilitygenetic 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 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 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.

Required Experience :

Staff IC

Key Skills

Machine Learning,Python,Data Science,AI,R,Research Experience,Sensors,Drug Discovery,Research & Development,Natural Language Processing,Data Analysis Skills,Toxicology Experience

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 177905 - 230230