Senior Director, External Manufacturing & Supply Operations (South San Francisco OR Radnor, PA)

We are looking for an expert Senior Director of External Manufacturing & Supply Operations to lead all outsourced manufacturing activities across Cytokinetics global supply chain network as we continue expand our clinical pipeline and prepare for the launch of Cytokinetics first commercial product. As our Senior Director, you will report to the Senior Vice President of Global Supply Chain & Technical Operations, and will be responsible for implementation and management of the company's overall Contract Manufacturing Organization (CMO) network. This includes relevant processes, procedures, metrics, team structure, and governance/business reviews with key supply partners supporting Clinical and Commercial manufacturing and supply. They will be a shown leader with extensive, hands-on outsourced manufacturing experience and will be responsible for recruiting, developing, and leading a team with primary accountability for overseeing Cytokinetics Drug Substance (DS), Drug Product (DP) and Labeling/Packaging CMOs. You will play a significant leadership role in CMO sourcing, supplier selection, contract negotiations and supply execution, all requiring proven hands-on experience.

Responsibilities

• Development & Continuous Improvement: Implement and lead Cytokinetics’s External Supply Operations Team. Scale and evolve the approved Operating Model, including the team structure, processes, metrics, and governance vital to ensure oversight of External Supply Operations.
• Development & Continuous Improvement: Develop processes by working directly with heads of Planning & Analytics, Technical Operations, Clinical Supply Operations, Quality and Finance to ensure that long term global manufacturing and supply needs are met. This includes input on existing site performance and capabilities, capacity expansion options/costs/lead times, participation in supplier selection and site establishment, and input on strategic imperatives required to improve functional capabilities to achieve competitive advantage.
• Development & Continuous Improvement: Identify and recommend appropriate actions, activities, and projects for continuous year over year, improvement.
• Collaboration: Directly engage and establish relationships with CMO senior leadership to ensure ongoing successful manufacture and issue resolution across the external manufacturing network.
• Collaboration: Develop collaborative relationships with internal stakeholders to understand organizational needs. Work with Planning & Analytics Team and Logistics to ensure execution of required all supply plans. Work with internal stakeholders (e.g., Clinical Operations, Development, Regulatory, Quality, Operations, Finance, etc.) to understand organizational needs. Support global regulatory filings and quality audits/inspections as the need arises.
• Collaboration: Communicate efficiently and build coordinated and supportive working collaborations teams, sites, and cross-functional departments.
• Collaboration: Work in a collaborative fashion with internal stakeholders and our CMOs to identify and drive performance improvements (COGS, cycle time, quality, etc.) to ensure efficient, reliable supply of all clinical and commercial products. Identify risks (business, performance, quality, regulatory, external, etc.) to ensure supply and work with site leaders, CMOs and internal stakeholders to develop effective mitigation plans.
• Team Leadership: Recruit, onboard, develop and lead a team of exceptional manufacturing and supply operations professionals to directly lead cross-functional teams responsible for ensuring successful partnership and execution with CMO’s.
• Team Leadership: Lead, coach, mentor, train and develop the External Supply Operations Team. Inspire the Team to achieve their productivity, efficiency, accuracy, and effectiveness goals.
• Budget & Financial: Budgetary responsibility for your span of control. Tracking and management of performance to budget.
• Project Management: Coordinate or be responsible for project activities within span of control.
• Metrics: Develop and maintain KPIs and data to measure effective operation of your team and span of control. Measure and report to senior leadership on overall performance of our CMO network.
• Role Specific: Plan, coordinate and facilitate all senior leadership site business reviews and visits including participation from senior leadership from Cytokinetics and our CMO partners.
• Role Specific: Provide input on CMO related risks to inform our overall supply chain and corporate risk management programs.

Qualifications

• BA or BS degree in Engineering, Chemistry or another relevant field.
• 12+ combined years of experience in Manufacturing, Contract Manufacturing, Technical Operations, Supply Chain or Quality.
• Direct experience in small molecule Drug Substance, Drug Product and Finish Pack manufacturing supporting both clinical and commercial products.
• International CMO management experience.
• Strong, proven hands-on people management experience and team development.
• Excellent written and oral communication and presentation skills. Strong problem solving, decision making, planning, analytical and project management skills.
• Excellent hands-on Organizational Change experience proven through strong cross functional collaboration and partnership.
• Ability to travel approximately 25%.
• Solid understanding of pharmaceutical development, manufacturing, packaging, and labeling.
• Demonstrated strong communication and collaboration skills with team members across functions including but not limited to clinical operations, manufacturing, commercial, finance, procurement, IT
• Ability to interact and communicate across multiple audiences, verbally and in writing.
• Experience using Excel including creating spreadsheets from scratch, moderate programming, and data sorting. Pivot Table experience a plus.
• Experience using Power Point to create presentations from scratch, ensuring consistent formatting, use of graphics and image, and balancing appropriate level of detail with clear and crisp messaging.