VP, Biologics Process Development

VP, Biologics Process Development
United States - California - Oceanside

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. Gileads 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 companys five core values. Thats 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

The Vice President, Biologics Process Development will be responsible for overseeing the development of biologic drug substance from research collaboration stage to commercialization. The VP will provide leadership to an organization responsible for Cell Line Development, Upstream Process Development, Downstream Process Development, Formulation/Drug Product Process Development, and Analytical Operations including Quality Control. As the leader of all the development functions for biologics, this position represents a single point of CMC accountability for advancing Gilead's biologics pipeline. In addition, the VP will be a member of the Biologics Leadership Team, which is responsible for providing leadership and decisions to the biologics development and commercialization strategies and operation at the Oceanside site.Responsibilities:

• Provide leadership and direction to the Biologics Process Development organization, a department of >100 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 Biologics 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 a new candidate biologics to development timelines and manufacturing strategy for IND and BLA
• Develop and execute DS and DP PPQ studies in alignment with Manufacturing and Technical Operations
• 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 biologics functions such as Quality Assurance, Manufacturing and Technical Operations, Biologics Business Support Organization, and Outsourcing
• Ensure strong relationships with Gilead headquarters functions including Research, Clinical Development, and Clinical Supply Management, by providing technical and strategic input
• Form and guide biologics development (CMC) teams consisting of representatives from each development function, in order 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.

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.
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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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:
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