Director, Outsourced Manufacturing

Location
Foster City, CA
Posted
Apr 27, 2022
Ref
2729114
Required Education
Bachelors Degree
Position Type
Full time
Director, Outsourced Manufacturing
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


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.

The Director of Outsourced manufacturing will play a critical role within the Chemical Development and Manufacturing (CDM) organization to drive multiple projects at both clinical development and commercial manufacturing stages. The Associate Director will ensure delivery of clinical and/or commercial materials (API drug substance and their intermediates) on time, in good quality and in full compliance. The Director will have the opportunities to work with colleagues across Gilead (Process Chemistry, Regulatory, Formulations, Analytical, Quality, Supply Chain, etc), as well as multiple CRO and CMO organizations. Strong technical skills (chemistry/engineering, GMP regulation and drug development, etc) and business skills (contract negotiation, project management and financial analysis, etc) will be called upon and excelled at this position.

Role and Responsibilities:

  • Creates and implements supply chain strategies across the global supply chain for Gilead's drug substances at all stages of the product lifecycle
  • Accountable for risk-based review of the supply chain in order to determine appropriate inventory levels of API
  • Collaborates in vendor and supplier selection, as well as suitable volume determination, based on the risk-minimization analysis
  • Ensures suitable quality, supply chain security, and optimal economics
  • Prepares strategic multi-year manufacturing plans to appropriately balance production across the core CMO network
  • Publishes metrics and maintains documentation to reflect the effectiveness and efficiency of department activities
  • Interacts collaboratively with cross-functional peer groups to deliver on Gilead's manufacturing goals.
  • Implements enterprise-level risk-mitigation planning for supply chain management for drug substance manufacturing.

    Education, Knowledge, Experience and Skills:

  • 12+ years of progressively responsible experience in a pharmaceutical/biotech organization and a BA or BS degree in chemistry or other relevant area of science.
  • An MBA degree can be substituted for 2 years of relevant experience, a Ph.D. degree can be substituted for 4 years of relevant experience.

  • Demonstrated track record in drug substance manufacturing and supply chain execution and oversight in the pharmaceutical industry (Small Molecule experience strongly preferred)
  • Expertise in supply chain risk management. Possesses in-depth knowledge of industry and system best practices.
  • Work experience in a regulated industrial setting. Solid knowledge of worldwide regulatory requirements, including pharmaceutical GMPs and ICH guidance
  • Experience and/or working understanding and application of manufacturing principles governed by current Good Manufacturing Practices (cGMP).
  • Solid understanding of the Contract Manufacturing Organization (CMO) landscape. Knowledge of CMO capabilities and limitations for worldwide drug substance manufacturing is a plus.
  • Strong communication, collaboration, and interpersonal skills a must. Experience in developing high-performing teams.
  • Ability to travel internationally, including overnight up to 10% of the time is required
  • Exceptional verbal and written communication skills, including ability to interact effectively with executive management

    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.

    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.

    Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since 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 a reasonable accommodation.​

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

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