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Gilead Sciences, Inc. Senior Director, Analytical Lifecycle Management — Biologics Quality Control in Foster City, California

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.

Job Description

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.

TITLE:

Senior Director, Analytical Lifecycle Management — Biologics Quality Control (Grade 33)

KEY RESPONSIBILITIES:

The Senior Director Analytical Lifecycle Management is vital for the success of Commercial Biologics QC, providing strategic leadership and overseeing daily operations. Responsibilities include managing commercial specification strategies, reference standards and critical reagents programs, analytical method validations and transfers, and the compendial review program. The role is accountable for monitoring QC test method execution and leading the analytical lifecycle management of commercial biologics drug substances and drug products. The Senior Director collaborates with cross-functional teams, fosters a culture of continuous improvement, and offers mentorship to the QC team for timely project completion and regulatory compliance.

FOCUS AREAS

You Will:

  • Oversee the development and implementation of end-to-end Specification strategy for Gilead’s portfolio of biologics products.

  • Have ultimate responsibility for staff development, and contribute to budgeting, cost control, and strategic planning of the Biologics Quality Control department. Provide leadership and guidance to direct reports and project team members to develop strong leaders at Gilead.

  • Lead, motivate, and develop the team, routinely making decisions to ensure project timelines are met.

  • Provide oversight and management of Biologics Reference Standards and Critical Reagents.

  • Demonstrate a clear understanding of biological product testing methods and assays for effective QC test method execution, troubleshooting, and remediation of atypical results.

  • Identify, select, manage, and evaluate CMOs/CTLs, consultants etc. to control quality in support of achieving PDM’s strategic objectives. Establish clear expectations, metrics and KPIs, as appropriate to monitor analytical method performance.

  • Be accountable for reviewing data and troubleshooting analytical testing within the Biologics portfolio across external network partners. Monitor test method execution in QC laboratories to ensure methods are in a continuous state of control.

  • Support validation of analytical methods for new Biologics programs and their transfer to outsourced partners to meet GMP testing needs.

  • Lead the Compendial Review Program, leveraging existing Gilead Quality Control Systems.

  • Lead or serve as a key project team member on large cross functional projects, often with high visibility to senior management within the organization or with international impact.

  • Provide a long-term view to senior QC Leadership based on personal knowledge of the competitive environment.

  • Interface with Regulatory agencies as required representing Gilead to authorities and regulatory inspectorates in matters relating to GDP.

REQUIREMENTS

You have:

  • Experience over a broad set of Quality Control sub-functions with extensive knowledge of industry best practices and trends.

  • In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally.

  • Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.

  • Must be able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness.

  • Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist.

  • Proven ability to work with senior management to develop and ensure the implementation of Company-wide long-term solutions.

  • Demonstrated an ability to develop a vision for Quality Control functions and have shaped the capabilities of the function to fulfill that vision.

  • Demonstrated experience and ability to manage and lead staff, with strong hiring and staff development skills, and the ability to motivate and engage individuals.

  • Demonstrated the ability to influence process and outcomes across functions.

QUALIFICATIONS:

  • 14+ years’ experience with a BS, OR 12+ years’ experience with a MS in related fields. An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is desirable.

  • Deep knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting trends in industry.

  • Prior senior leadership experience required.

  • Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.

  • Strong organizational and planning skills.

  • Shows excellent verbal and written communication skills and collaborative interpersonal skills.

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: $237,660.00 - $307,560.00. 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:

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' (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

PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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.

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