Director External Supply Operations

Job Description

Cytokinetics, a cardiovascular biopharmaceutical company, is seeking a Director of External Supply Operations. This role is responsible for the operational execution of external manufacturing and related supply activities. The Director will collaborate with Supply Chain, Quality Assurance, Regulatory Affairs, and Finance to execute global supply plans for clinical and commercial supply.

• Build and maintain relationships with external contract manufacturers (CMO’s)
• Ensure timely execution of supply plans at assigned CMO’s
• Develop and manage production processes
• Support logistics, transportation, and import/export activities
• Lead all aspects of Supply Execution with assigned CMOs
• Act as supply chain representative for documentation review and approval
• Support product qualification activities
• Develop and execute manufacturing strategies for product launches
• Collaborate with the Supply Planning team
• Manage and track inventory
• Issue purchase orders, and track invoices and budgets
• Maintain production schedules
• Support negotiation of price tiers and terms across multiple sources of supply
• Oversee a continuous performance assessment and utilization of KPIs of contract manufacturing partners
• Oversee, review, and approve revisions to manufacturing cGMP and non GMP documentation
• Support the design, implementation, and monitoring of supply risk mitigation strategies
• Build and maintain strong partnerships and provide effective communications with all internal and external stakeholders
• Responsible for scheduling and maintaining routine business operations meetings with CMO’s.

• BS/BA Degree in Life Science, Biology, or Engineering discipline
• 15+ years combined experience in manufacturing, outsourced operations, technical operations and/or supply chain in regulated healthcare industry
• Technical background with knowledge of engineering and pharmaceutical manufacturing processes
• Ability to function in a fast-paced, high-growth, entrepreneurial environment
• Ability to travel domestically and internationally ~15%
• Strong working knowledge and understanding of regulations by government agencies affecting the pharmaceutical industry (CFR's)
• Timely and effective communication across multiple audiences, both verbally and in writing

• Opportunity to work for a late-stage biopharmaceutical company
• Chance to make a positive impact on patients' lives
• Collaborative and supportive work environment