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

　　The Director, Biologics Analytical Development (Pre-Pivotal) will be responsible for leading analytical development strategies including method development, qualification, and transfer. He/She will be responsible for molecule characterization for Gilead’s biologics entities during pre-pivotal phases of development (pre-clinical, phase I/II). He/She will also be responsible for developing control strategies for biologic drug substance and drug product as well as analytical regulatory strategies to enable successful regulatory filings. 

　　*Responsibilities: *

　　Establishand lead characterization, analytical control, regulatory strategies for biologic drug substance and drug product. Author associated test procedures, protocols, reports, and regulatory filings.

　　Lead analytical method development, validation, and transfer activities in support of PDM (Pharmaceutical Development & Manufacturing) project team needs. Oversee data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations globally.

　　Establish and maintain a state of the art analytical development laboratory that will allow for rapid process development support, development of control system as well as product characterization methods.

　　Hire, mentor, and develop a team of scientists with a focus on analytical excellence as well as teamwork and collaboration across all PDM organizations.

　　Provide leadership and direction to members of his/her team within the Pre-Pivotal Analytical Development and QC Operations organization.

　　Support regulatory filings by authoring/reviewing CMC regulatory sections of IND/INDa; support associated agency interactions and product-related inspections.

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

　　Evaluate and implement state of the arttechnologies to drive innovation in Analytical Development and testing.

　　Serve as, and/or coach employees as, analytical lead for PDM pre-pivotal biologics programs to ensure successful IND/INDa applications.

　　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.

　　Provide technical support to internal and external cGMP manufacturing operations.

　　*Qualifications: *

　　Ph.D. with 10+ years OR M.S. with 15+ yearsin Analytical Chemistry or related fields of industrial experience in biologics analytical development with people leader accountabilities.

　　Extensive experience with analytical method development, validation, and control strategies of biologic products. 

　　Extensive experience with separation (HPLC, CE-SDS. iCIEF) methods and well versed in mass spectrometric technologies/data interpretation.

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

　　Demonstrated ability of building strong collaborations with other CMC functions. 

　　Strong business acumen, be able 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. 

　　Gilead Core Values

　　Integrity (Doing What’s Right)

　　Inclusion (Encouraging Diversity)

　　Teamwork (Working Together)

　　Excellence (Being Your Best)

　　Accountability (Taking Personal Responsibility) 

　　The salary range for this position is: $221,170.00 - $286,220.00. 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 [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

　　PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/ofccp/pdf/pay-transp_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.

　　Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. T he health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.

　　The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request an accommodation.