VP, Pre-Pivotal Biologics Process Development

VP, Pre-Pivotal Biologics Process Development
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

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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


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.

VP, Pre-Pivotal Biologics Process Development

The Vice President, Pre-Pivotal Biologics Process Development will be responsible for overseeing the development of biologic drug substance from research collaboration stage to the pivotal stage development. The incumbent will provide leadership to an organization responsible for Cell Line Development, Pre-Pivotal Upstream Process Development, Downstream Process Development, Formulation/Drug Product Process Development, and Pre-Pivotal Analytical Development including Quality Control. As the leader of all these development functions for biologics, the individual will represent a single point of CMC accountability for advancing Gilead's biologics pipeline into the IND and pre-pivotal clinical studies. In addition, the incumbent will be a member of the Technical Development Leadership Team, that is responsible for providing leadership and decisions to the development and commercialization strategies of all modalities.

Responsibilities:

• Provide leadership and direction to the Pre-Pivotal Biologics Process Development organization, a department of >150 scientists and engineers
  
• Advance biologics candidates in pipeline by providing overall CMC oversight, direction and decision.
  
• Provide strategic directions to all biologics projects through interactions with each biologics development (CMC) team
  
• Serve as a senior member of the Technical Development Leadership Team responsible for developing and establishing biologics strategy and site operations
  
• Oversee development operations for biologics projects, including mAbs, recombinant proteins and therapeutic virus vaccines, from early phase to commercialization
  
• Translating non-clinical and clinical study demand of new candidate biologics to development timelines and manufacturing strategy to support INDs
  
• Evaluate and implement new technologies to drive innovation in biologics development, testing, and manufacturing
  
• Drive development and implementation of new systems to improve project execution and data management
  
• Lead collaborations with Gilead PDM (Pharmaceutical Development Manufacturing) functions such as Quality Assurance, CMC Reg, Manufacturing and Technical Operations, Product and Portfolio Management, Finance and Supply Chain,
  
• Ensure strong relationships with key stakeholder functions including Research, Clinical Development, and Clinical Supply Management and PSTs, by providing technical and strategic input
  
• Form and guide biologics development (CMC) teams consisting of representatives from each development function, to drive and manage each biologic under development
  
• 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:

• PhD in Chemical Engineering or related disciplines
  
• 15+ years of biopharmaceutical industry experience with no less than 10 years of that experience focusing on biologics manufacturing process development utilizing mammalian cell lines
  
• Experience leading cross-functional biologics development (CMC) teams consisting of representatives from multiple functions such as Cell Line Development, Upstream Process Development, Downstream Process Development, Formulation/Drug Product Process Development, and Analytical Operations including Quality Control
  
• Experience supporting multiple regulatory filings including IND and BLA and supporting product-related inspections for US and foreign regulatory agencies
  
• Experience developing, implementing and executing strategic plans and objectives for organizations and departments
  
• Experience working with external manufacturing and testing organizations
  
• Experience with viral vectors is a plus
  
• In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of biologics
  
• Solid understanding of current industry trends and regulatory expectations associated with QbD, comparability evaluation, scale up, and method and process validation
  
• Exceptional interaction, leadership and command skills are required
  
• 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.
  

People Leader Accountabilities

• 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.




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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 careers@gilead.com for assistance.

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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.






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