Director, Outsourced Manufacturing
Director, Outsourced Manufacturing
United States - California - Foster CityUnited 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
Director, Outsourced Manufacturing
Location: Foster City, CA (Morris Plains, NJ is an acceptable alternate location)
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 position is responsible for the supplier relationship and performance management of assigned commercial drug product contract manufacturing organizations (CMOs). This position coordinates between all relevant Gilead functions and CMO functions to ensure strategies and supply plans are executed and achieved as planned. This includes driving performance of the strategic relationship under the direction of the department Exec. Director and in conjunction with Commercial Manufacturing, Analytical Operations, Quality, Development and other Gilead functions, as needed. This position will lead the respective CMO Management Teams for assigned CMOs and support implementation and execution of CMO initiatives as part of the larger Gilead CMO governance model. This person will work with CMO management to measure and drive results and initiatives, and to develop and maintain collaborative relationships. This position will also serve as the production champion for assigned CMOs and will lead the resolution of supply issues and risk mitigation at respective CMOs. This person will support Gilead Supply Chain Management in the development of supply mitigation plans with CMOs in response to critical supply issues.
Essential Duties and Job Functions:
- Serve as the primary day to day contact to support the relationship between Gilead and assigned CMOs
- Serve as the production champion/point of contact (POC) with assigned CMOs to manage and mitigate issues and drive robust supply of product through coordination across commercial functions.
- Manage external manufacturing activities and relationships. Serve as the day to day internal representative for CMO management at assigned CMOs.
- Execute strategies that drive effective operational performance and service levels at CMOs. Strong alignment with Supply Chain, Commercial Manufacturing, and Quality is required.
- Lead initiatives that drive a collaborative and robust relationship and drive alignment between CMOs and Gilead including but not limited to: Business reviews, Performance Metrics, Continuous Improvement projects, and Risk Management.
- Support and effectively execute CMO Management initiatives and cross functional efforts, processes and strategies to ensure supply performance is achieved, both at the CMO and within Gilead.
- Utilize analytical tools to identify, quantify, and minimize risks at assigned CMOs
- Negotiate and manage key CMO agreements (MSAs, SOWs, Supply Agreements, Pricing, etc.)
- Implement and manage joint operating procedures between Gilead and the supplier/CMO to ensure effective execution.
- Report metrics and lead supplier specific performance improvement initiatives
- Understand the CMO market and capabilities that are consistent with Gilead's manufacturing requirements. Develop relationships with potential CMOs that support Gilead's future CMO needs
- Coordinate interdepartmental activities with Quality Assurance, Manufacturing, Development and other functions that support commercial supply.
- Work closely with department management to establish standards and policies that support key CMO/supplier partnerships.
Knowledge, Experience, and Skills:
- Ability to influence and work well with others in a proactive and constructive manner.
- Strong communication skills, both verbal and written, with all levels of an organization
- An independent self-starter with the ability to resolve supplier performance challenges and implement process and/or system improvements
- Ability to develop, analyze, and leverage key metrics to improve overall business performance
- Proven ability to problem solve, build strong relationships, and to organize effectively
- Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions
- Expertise in domestic and international cGMPs
- Demonstrated ability to multi-task and to work across multiple multi-national sites and diverse cultures
- Prior experience working with large molecule/biologic CMOs and/or manufacturing processes highly desired.
- Prior experience working with parenteral and/or solid dose CMOs and/or manufacturing also a plus.
- BS degree in related field required. Advanced degree including MBA or MS preferred
- Familiarity with ERP and supply chain systems a plus
- Prior experience managing contract manufacturing highly desirable
- Prior experience in pharmaceutical operations and cGMP environment(s) highly desirable
- BA/BS with 12+ years of relevant experience in a related field or MBA/MS plus 10+ years of relevant experience in a related field
- Travel required - up to 25%
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 email@example.com for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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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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