Senior Director Manufacturing

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.

Overview

Reporting to the SVP, US Manufacturing Operations, the Senior Director, Manufacturing Operations will coordinate, plan, and oversee execution of all commercial production activities, including near-term and long-term production planning, strategic growth planning, and proactive assessment and mitigation of operational risks. The Senior Director, Manufacturing Operations will lead the commercial production team and ensure key performance indicators are achieved while maintaining the highest standard of quality and program budgets.

KEY ACCOUNTABILITIES

People Leadership

• Actively contribute to senior leadership team decisions, working collaboratively with leaders responsible for indirect production and support activities to deliver operational and financial outcomes, and strategic production priorities
• Provide leadership and direction in the management and delivery of production systems and products, ensuring required policies, standards, performance expectations, and service levels are established and maintained
• Lead by example, consistently demonstrating alignment with organizational values, policies and goals
• Identify and implement initiatives to attract and retain top talent and take an active role in ensuring new employee onboarding is a success
• Drive engagement and create a culture where employees are motivated to do their best

Production Execution

• Develop business strategies and plans to ensure alignment with POINT’s short and long-term objectives
• Oversee the maintenance of performance metrics and production systems for cross-functional operations teams
• Deploy operational strategy and produce finished product in accordance with customer demand
• Ensure that all activities and operations are performed in compliance with health regulators, radiation safety, local, state, federal regulations, and laws governing business operations
• Engage with Supply Chain representatives to ensure adequate material inventory levels and appropriate vendor risk management
• Maintain production schedules ensuring batch fulfillment for both clinical and commercial operations
• Foster and maintain a strong production quality culture, focused on cGMP compliance
• Work closely with production team to troubleshoot processes and equipment problems, while minimizing downtime and impact to patients
• Initiate new programs at the Indianapolis facility and work closely with project managers and cross-functional stakeholders to meet program timelines and objectives
• Effectively communicate results of departmental work through reports and dashboards to a broad audience, including cross-functional departments, executive leadership, and external stakeholders
• Oversee daily activities for the clinical and commercial production department to ensure quality results and team member performance aligns with goals and expectations

Risk Assessment and Contingency Planning

• Lead continuous risks assessment and failure mode analysis, and develop short -term and long-term mitigation strategies and contingency plans for all programs and processes
• Proactively identify continuous improvement strategies across all programs and processes
• Lead failure mode and effects analyses for all programs
• Analyze variances in operational and financial targets, develop and execute corrective action plans as required

Requirements

Education and Experience:

• Engineering, science, or technical degree
• 10+ years of relevant experience in a GMP drug product manufacturing environment, preferably in a commerci