Associate Director, Strategic Sourcing & Supplier Management, Sterile Drug Product and Biologics

About the role

The Associate Director, Strategic Sourcing & Supplier Management, Sterile Drug Product and Biologics is responsible for owning the strategic business relationship with multiple contract development and commercial manufacturing organizations (CDMOs). This includes strategy, selection, risk, and performance management of CDMOs providing small molecule sterile drug product, biologics drug substance and drug product, and antibody drug conjugates to Gilead.

Responsibilities

• Serve as the point of contact for strategic business discussions, long range supply and capacity planning, and business development
• Manage supplier performance (monthly/annually)
• Lead annual business review meetings (BRMs)
• Lead the assessment and mitigation of supplier risks through regular supplier risk management processes
• Prepare, review, challenge, and track RFPs/RFQs/RFIs for new business with external suppliers and in consultation with functional stakeholders
• Lead and/or support site assessment teams (SATs) in the assessment and selection of suppliers
• Negotiate Confidentiality Agreements, Master Services Agreements and Work Orders
• Support make vs. buy analysis
• Coordinate/lead meetings internally and with CMO’s and publish meeting minutes
• Provide leadership and training to other department personnel
• Develop budgets and accurately report accruals to Finance if/as needed
• Communicate issues to line manager and project teams in a timely manner
• Support product team (PDM subteam and/or CMC) needs for the selection of external service and/or material suppliers to provide required services and/or supplies from development through commercialization
• Stay informed and knowledgeable of relevant development and commercial CDMO supplier capabilities, offerings, capacities, etc. as they relate to potential or known Gilead pipeline needs
• Collaborate and establish regular meetings with key stakeholders and partners to ensure outsourced needs are met
• Organize and participate in teleconferences and face-to-face meetings with global CMOs; work closely with Gilead teams to establish agenda and keep track of key decisions

Qualifications

• 10+ Years with BS/BA OR 8+ Years with MS/MA or MBA
• Prior experience leading outsourced development and manufacturing service providers and/or direct material suppliers
• Understanding of activities related to the CMC development of biopharmaceuticals
• Knowledge of GMPs and associated regulations (21CFR parts 11, 210, 211, 820)
• Strong people management skills
• Ability to lead cross functional teams
• Strong verbal and written communication skills
• Ability to manage multiple programs/projects; sound organizational and time management skills
• Ability to develop concise presentations to convey issues to senior management
• Ability to work under uncertainty and to resolve conflict in a constructive manner
• Ability to solve complex problems through ingenuity and collaboration with subject matter experts and other key stakeholders
• Experience negotiating supply agreements
• Experience in a pharmaceutical/biotech organization or relevant manufacturing environment

Benefits

The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For Additional Benefits Information, Visit here.