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Gilead

Director, Outsourced Manufacturing

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Director – Analytical and Biologics Outsourcing

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 on-going 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.

Gilead Biologics is experiencing a period of rapid growth and investment and the Outsourced Manufacturing group is currently seeking a Director to lead the Oceanside, CA team. This role will work closely with the development teams to lead the outsourcing of development, manufacturing and analytical testing of biologic products. 

Main Responsibilities:

  • Actively manage large molecule outsourced development, manufacturing and analytical testing to Contract Manufacturing Organizations (CMOs) and Contract Testing Laboratories (CTLs)
  • Negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
  • Prepare, review and challenge request for proposals
  • Ensure accurate and on-time payments to our partners
  • Lead and participate in Operational Excellence projects
  • Monitor and verify implementation of Gilead’s controlled documents at CMOs and CTLs with Gilead’s Contractor Manuals (CMs) system
  • Coordinate/lead meetings internally and with CMOs/CTLs, publishes meeting minutes
  • Write, revise and review Standard Operating Procedures
  • Provide training and guidance to other department personnel
  • Develop budgets and accurately report accruals to Finance
  • Lead/support business reviews for assigned partners
  • Participates in solving issues of high complexity
  • Communicates issues to line manager and project teams in a timely manner

Job Functions and Duties:

  • Collaborate and establish regular meetings with key stakeholders to ensure outsourced needs are met; Lead Business Reviews with CMOs and CTLs.
  • Evaluate and onboard CMOs and CTLs s including site visits, contract negotiating, initiating GMP audits, applicable Work Orders and Purchase Orders
  • Maintain outsourced project timelines and evaluate progress against established dates
  • Collaborate with key stakeholders to prioritize activities according to project needs
  • Maintain oversight of financials and project deliverables associated with outsourced development activities
  • Organize and participate in teleconferences and face-to-face meetings with CXOs/CTLs; work closely with Gilead teams to establish agenda and keep track of key decisions
  • Proactively communicate issues, project changes to key stakeholders and facilitates timely discussion and resolution
  • Maintains and updates documentation and timelines to accurately reflect the status of the outsourced activities
  • Manage outsourcing staff including training, coaching and doing performance assessments

Knowledge, Experience and Skills:

  • 12+ years of experience in a pharmaceutical/biotech organization or relevant manufacturing environment and a BA or BS degree; an MA/MBA degree may be considered as 2 years of relevant experience and Ph.D. may be consider as 4 years’ experience.
  • Prior experience leading biologics outsourced development, manufacturing and testing
  • Strong computer skills and experience with an ERP system and project management software
  • Extensive understanding of activities related to the CMC development of biopharmaceuticals
  • Advanced knowledge of GMPs and associated regulations
  • Ability to collaborate with cross functional teams
  • Strong people management skills
  • Strong negotiation, verbal and written communication skills
  • Ability to manage multiple programs/projects; sound organizational and time management skills is essential
  • Ability to work under uncertainty and to resolve conflict in a constructive manner
  • Ability to solve highly complex problems through ingenuity and collaboration with subject matter experts and other key stakeholders
  • Ability to work in a fast-paced environment is essential
  • Project management experience and/or certification are a plus
  • This position may require up to 25% domestic and international travel


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.

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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:

Please log onto your Internal Career Site to apply for this job.

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