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.

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.

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

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Role And Responsibilities

The Director, Development Biologics Tech Operations in the Pre-Pivotal Biologics Technical Development group will have sole accountability for Upstream and Downstream Development Biologics Technical Operations. In this role you will be responsible for both upstream and downstream tech transfers and manufacturing support activities for all internal and external drug substance manufacturing sites and drive business process improvements related to tech transfer, operational support and technical oversight of manufacturing.

Essential Duties And Job Functions

• Leads the Development Biologics Technical Operations group that is responsible for both Upstream and Downstream technology transfer and manufacturing support activities for all internal and external manufacturing sites
• Defines strategies for consistent and phase-appropriate oversight of DS process transfer and manufacturing
• Drives business process improvements related to tech transfer, operational support and technical oversight of manufacturing,
• Directs activities of the technical operations group including defining, planning and implementing projects related to scale-up, technology transfer, facility fit and/or process validation between sites
• Directs the development of technical projects and initiatives, determines metrics for success and evaluates performance against metrics
• Partners with Gilead’s Biologics Quality, Process Development and Outsourced Manufacturing groups to ensure project timelines, deliverables, and business operations are aligned and met
• Focuses on strategic planning and execution while managing within the budget
• Supports regulatory inspections and authoring of relevant sections of IND, BLA and MAA filings
• Ensures compliance to safety, business policies, laws and regulations applicable to the operations
• Routine travel may be required in support of technology transfers and manufacturing oversight of CMOs
• Tech Transfer Lead: Leads the cross-functional drug substance tech transfer team to implement manufacturing processes at CMOs,
• Owns the end to end tech transfer timeline, makes sure the deliverables are executed on time and ensure successful drug substance productions.
• Aligns with stakeholders across functions including Global Supply Chain, Strategic Sourcing Supply Management, Operations and Logistics at Gilead Oceanside and Gilead La Verne, External Quality Assurance, Site Quality Assurance, Internal and External QC, and Technical Development; Cell Culture, Purification, MSAT, Formulation, Pilot Plant, Cell Line Development
• Establishes partnerships with key stakeholders across the internal organization, including PDM Strategy (PDM Leads and PMs) to ensure pre-pivotal tech transfer projects meet timeline and clinical readiness expectations to support the early phase Biologics pipeline.
• Fosters a highly collaborative and trusting relationship between Gilead team members and external partner team members, realizing benefits to Gilead including external partner flexibility, collaboration, and transparency
• Direct technical teams through objective decision-making processes to enable process finalization and implementation at partner sites, by assembling SMEs and requisite information while giving input and/or escalating to stakeholders when applicable.
• Initiates and oversees strategy teams which define IND-enabling business processes and lead teams through continuous improvement of transfer strategies and processes with each execution of technical transfer
  
  

Knowledge, Experience And Skills

• 12+ years of experience in the pharmaceutical industry and a BS or BA.
• 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
• In-depth knowledge of manufacturing principles and concepts and industry best practices and trends
• Significant experience with upstream and downstream bioprocessing equipment and operations from thaw through harvest through protein purification and drug substance fill
• Strong knowledge of cGMP requirements for clinical and commercial manufacturing
• Broad experience across areas such as manufacturing and development
• Proven experience in the generation of relevant regulatory sections of IND, BLA and MAA filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections
• Demonstrated success as a people manager
• Vaccine and ADC process and regulatory experience is desired
• Prior experience in MSAT, PD and Manufacturing is preferred
  
  

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

The salary range for this position is: $210,375.00 - $272,250.00. 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

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 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.

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