Sr. Director/Director, Supply Chain

SUMMARY:

The individual will oversee and direct all third party manufacturing and supply and provide business oversight for all CMC contract research and development services in support early development, clinical development and commercialization.   In collaboration with the senior management team, this individual will establish and communicate a supply chain strategy and independently lead the implementation.  He/she will establish and implement rigorous supplier relationship and performance management programs and supply planning and execution processes.  This individual will work cross-functionally and provide guidance and support to internal groups such as business development, marketing, FP&A, CMC development functions, regulatory and quality as well as to outside groups such as contract manufacturing organizations to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP, GMP, DSCSA).  He/she will select, develop and evaluate personnel to ensure the efficient operation of the supply chain function.

RESPONSIBILITIES:

• Develop and recommend outsourcing, manufacturing and supply strategies for clinical and commercial supplies
• Lead technical execution of defined strategies for manufacturing and supply chain
• Establish and implement supplier relationship and performance management program (KPI measurements, reporting and periodic reviews, oversight of improvement programs)
• Identify and manage appropriate suppliers for key starting materials and intermediates
• Evaluate and select CROs, CDMOs, and CMOs using rigorous processes with defined criteria
• Negotiate and maintain external CMO manufacturing contracts
• Develop, establish, document and implement Supply policy at all points along the supply chain
• Establish supply planning processes for raw materials through clinical and commercial product
• Oversee supply chain planning and inventory management to ensure materials are available to support development and commercial demand
• Responsible for accurate commercial inventory balances (99% or greater) with our Contract Service Providers (CSP’s), performance of physical inventory, and reconciliation as required
• Coordinate technology transfer from development to international or domestic CMOs
• Coordination of external CMOs towards successful execution of manufacturing campaigns
• Execution of phase III and commercial manufacturing strategies including process validation, PAI and launch
• Responsible for development and implementation of supply chain function and organization
• Primary day-to-day contact and business manager for suppliers and OUS Partners (as appropriate)
• Works closely with leadership team on key aspects and strategy for Mirati Operating Plans
• Represent Supply Chain at internal meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program
• Maintain up-to-date Technical and Operational knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive process design, data analysis and strategy development
• Monitor and enforce GLP and GMP regulations
• Provides recommendations and input on departmental policies, new product opportunities, product developmental strategies, procedures, resourcing, budgets, goals and objectives. Assist and advise the Technical Operations Leadership as required.

REQUIREMENTS:

• Masters or bachelor’s degree in life sciences or business plus 18+ years of relevant industrial experience in bulk drug substance and dosage form manufacturing and supply
• Extensive management experience (12+ years) with GLP and cGMPs, worldwide regulatory requirements and current industry practices
• Successful history building and managing supply chain functions
• Advanced degree or certification in business, supply chain management (APICS) preferred
• Ideal candidates will have significant experience with clinical and commercial supply chains and GMP manufacturing combined with exceptional project leadership, 3^rd party business development, organizational, and communication skills
• Must have worked with and possess a strong knowledge of MRP/ERP systems and procedures
• Ability to effectively organize and prioritize tasks to achieve established deadlines
• Ability to multi-task and adapt rapidly to changing business requirements in a dynamic environment
• Ability to travel up to 30% domestically and internationally
• Exceptional written and verbal communication skills
• Exemplary integrity, code of conduct and ethics