Exec Director, Outsourced Manufacturing
Exec Director, Outsourced Manufacturing
United States - New Jersey - Morris Plains
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
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. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.
Executive Director Manufacturing Sciences & Technology, Biologics
The Executive Director, Biologics MS&T will be responsible for overseeing the commercialization of Biologics and Anti-body Drug Conjugates (ADCs). The ED will provide leadership to an organization responsible for mAb upstream process, downstream process, conjugation, drug product process, and analytical operations. As the leader of all the MS&T functions for Biologics, this position represents a single point of CMC accountability for advancing Gilead's Biologics commercial portfolio. In addition, the ED will be a member of the Biologics Leadership Team, which is responsible for providing leadership and decisions to the Biologics and ADC commercialization strategies and operation at the Morris Plains, NJ site.
- Build a MS&T organization and wet lab capabilities in support of growing Biologics and ADC commercial portfolio
- Provide leadership and direction to the Biologics MS&T organization
- Advance Biologics commercial support for Trodelvy and Ph2/3 assets by providing overall CMC oversight, direction, and decisions.
- Provide strategic directions to all Biologics programs to assess facility fit and long-term manufacturing footprint
- Serve as a senior member of the Biologics Leadership Team responsible for establishing commercial Biologics strategy and direct support to internal and external operations
- Partner with Biologics Process Development to ensure successful commercialization of the Biologics development portfolio
- Execution of process robustness assessments, product characterization studies and scale-down models, and continuous improvement programs
- In partnership with Process Development, execute mAb, DS, and DP PPQ studies across Gilead's global manufacturing network
- Drive process and analytical method tech transfers, implementation of CPV program, and projects to improve project execution and data management
- Lead collaborations and complex investigations with Gilead Biologics functions such as Quality Assurance, Process Development, Biologics Business Support Organization, and Outsourcing
- Form and guide Biologics commercial (CMC) teams consisting of representatives from various functions, in support of BLA and global filings.
- Develop and motivate a team of highly capable, experienced SMEs to support objectives of the role in addition to prioritizing available resources, balancing urgent and the important activities, such that supply continuity is ensured by reducing process, technical or executional risks.
- Support regulatory agency interactions and product-related inspections
- Provide technical support to internal and external cGMP manufacturing operations
- Develop and manage department budget
- Masters or 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/technical operations, focusing on process optimization utilizing mammalian/murine cell lines
- Experience leading cross-functional Biologics CMC teams consisting of representatives from multiple functions such as Upstream Process, Downstream Process, Drug Product Process Development, and Analytical Operations.
- Conjugation experience with ADCs strongly preferred.
- Experience supporting multiple regulatory filings including BLA/MAA 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
- In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of Biologics and/or ADCs
- 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 email@example.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 firstname.lastname@example.org 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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