Manager Outsourced Manufacturing, Formulations and Product Development

Manager Outsourced Manufacturing, Formulations and Product 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


Manager - Outsourced Manufacturing, Formulations and Product Development

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.

This role will work closely with development teams to lead the outsourcing of development and manufacturing at contract manufacturing organizations.

Main Responsibilities:

• Actively manage the outsourced development and GMP manufacturing of drug product at Contract Manufacturing Organizations (CMOs). Projects include parenteral products, solid oral dose forms, medical devices, and/or clinical packaging,
• Effectively negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
• Prepare, review and negotiate request for proposals
• Enter purchase requisitions to Gilead accounting system (Oracle)
• Ensure accurate and on-time payments to Gilead partners
• Monitor and verify implementation of Gilead's controlled documents at CMOs
• Write, revise and review Standard Operating Procedures
• Develop budgets and accurately report accruals to Finance
• Support business reviews with CMOs and external partners
• Effectively communicate issues to management and project teams
• Participate in Operational Excellence projects

Job Functions and Duties:

• Organize and participate in teleconferences and face-to-face meetings with CMOs; work closely with Gilead teams to manage deliverables
• Maintain outsourced project timelines and ensure progress against established dates
• Onboard CMOs including integration into Gilead systems
• Maintain oversight of financials and project deliverables associated with outsourced development and testing activities
• Proactively communicate issues, project changes to key stakeholders and facilitate timely discussion and resolution
• Maintain project documentation

Knowledge, Experience and Skills:

• Prior experience in outsourced development and manufacturing
• Experience in parenteral products is highly desirable
• Strong computer skills and experience with an ERP system and project management software
• Good understanding of activities related to the CMC development
• Knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)
• Ability to lead 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 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 5% domestic and international travel

Minimum Qualifications:

• 7+ years of experience in a 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.

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:
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