For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

The Executive Director, Biologics Analytical Development and QC Operation (Pre-Pivotal) will be responsible for leading all aspects of analytical development and QC operations including method development/qualification, molecule characterization, QC operations for all of Gilead’s biologics entities during pre-pivotal phases of development (pre-clinical, phase I/II). He/She will also be responsible for the overall control strategy of raw material, drug substance and drug product as well as analytical regulatory strategies.

Responsibilities:

• Provide leadership and direction to the Pre-Pivotal Analytical Development and QC Operations organization.

• Set strategies and develop long-range plans in line with Gilead strategic priorities to deliver on Gilead’s long-term ambitions

• Provides technical guidance and drives alignment of near-term deliverables and long-range plans with respect to analytical control strategies and regulatory strategies for drug substance and drug product quality attributes across all PDM (Pharmaceutical Development & Manufacturing) functions

• Oversee analytical method development and validation, QC operation for biologics drug substances and drug products from pre-IND to Phase II · Oversee data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations globally,

• Participate in review of relevant biologics molecule PDM project reviews

• Serve as a member of the Pre-Pivotal Biologics Process Development Leadership Team responsible for developing and establishing analytical development and QC operation strategies

• Evaluate and implement new technologies to drive innovation in Analytical development and testing

• Drive development and implementation of new systems to improve project execution and data management

• Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Regulatory Affairs, Manufacturing and Technical Operations, Product and Portfolio Management.

• Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Clinical Supply Management and Program Strategy Teams by providing technical and strategic input

• Hire, mentor and develop team members within the organization

• Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections

• Provide technical support to internal and external cGMP manufacturing operations

• Develop and manage department budget

Qualifications:

• Ph.D. in Analytical Chemistry or related fields with 15+ years of industrial experience in biologics analytical development with people leader accountabilities

• Extensive experience with analytical method development, validation, control strategies and QC operations of biologics with demonstrated phase appropriate approaches.

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

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

• Strong business acumen, be able to balance resource, budget and program milestone.

• 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. · Proven 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.

Gilead Core Values

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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 careers@gilead.com for assistance.

The salary range for this position is: $266,815.00 - $345,290.00. 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.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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 log onto your Internal Career Site to apply for this job.