Associate Director, External Manufacturing, Biologics

Senior Manager, External Manufacturing, Biologics

The Senior Manager level position in Gilead's External Manufacturing organization will be responsible for managing manufacturing and analytical testing activities outsourced to contract manufacturing organizations (CMOs) and third-party contract laboratories (CTLs). We are seeking candidates with working experience collaborating with CMOs and outsourced testing laboratories with prior experience in clinical and/or commercial biologics in an external manufacturing and/or business development setting. This individual will be a key point of contact between Gilead and one or more external partners, responsible for supplier relationship inclusive of the bidding, selection and lifecycle and performance management of one or more biologics programs.

Specific Responsibilities

• Manages outsourced activities for biologics bulk drug substance, drug products, and analytical testing
• Serves as the primary day to day contact to support the relationship between Gilead and assigned contract organizations
• Develops strategy for management of outsourced testing needs, considering timelines, risk mitigation and business priorities
• Develops, executes and ensures compliance to procedures for outsourced manufacturing and testing oversight
• Develops effective strategies for the evaluation and selection of contract organizations.
• Coordinates with legal, the technical and development teams and quality assurance/control groups to establish confidentiality/nondisclosure agreements, service terms and conditions, and quality agreements
• Reviews and facilitates approval of proposals, work orders, and changes of scope.
• Assists in transfer of new programs to various contract organizations
• Coordinates manufacturing and testing schedules based on program requirements
• Monitors and troubleshoots key outsourced activities via email, teleconferences, site visits and annual business review meetings
• Executes strategies that drive effective operational performance and service levels at contract organizations
• Communicates risks and delays to management and technical leads on a timely basis
• Develops metric parameters to evaluate and monitor the performance of contract service providers
• Participates in site visits as required
• Supports strategic business and quality compliance processes and changes
• Provides input for budgeting based on outsourced manufacturing and analytical testing needs
• Negotiate and manage key agreements (MSAs, Statements of Work, Change Orders, Pricing, etc.)
• Effectively communicate project, performance, and resource issues to management and project teams
• Ability to travel domestically and internationally 5-10% of the time

Knowledge & Skills:

• Able 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.
• 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.
• Demonstrated ability to multi-task and to work across multiple multi-national sites and diverse cultures.

Education & Experience

• A Bachelor's Degree and a minimum of eight (8) years of experience, OR a Master's Degree with a minimum of six (6) years of experience.
• Experience with drug substance manufacturing and analytical/QC testing for large molecules/biologics.

Preferred/Desired Experience

• Direct experience managing CMO and supplier relationships and contracts.
• Experience with large scale biologics operations
• Strong understanding of the GMPs.

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.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg

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.

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