PSC Operations Management Director

Duties/Responsibilities

• Lead with Agility: Drive end-to-end execution of CMC development and manufacturing activities from early development through commercial readiness, adapting to evolving priorities and challenges.
• Ownership of Operational Delivery: Translate strategic program goals into actionable operational plans; take full accountability for day-to-day execution of CMC deliverables.
• Foster Collaboration and Engagement: Build partnership across internal stakeholders and external CDMOs to ensure readiness for each phase of development and manufacturing.
• Solve Problems and Minimize Risk: Proactively identify technical, operational, and supply risks; develop and implement mitigation strategies and resolve issues before escalation.
• Ensure Excellence in External Partnership: Monitor CDMO performance, ensure alignment with quality and regulatory standards, and drive accountability for results.
• Champion Strategic Initiatives: Drive or support PSC-wide initiatives focused on cost optimization, reliability, and patient-centric improvements.
• Demonstrate Executive Presence: Promote consistency, best practices, and continuous improvement across business operations in PSC. Influence decision making and drive alignment across key stakeholders.

Additional Responsibilities

• Provide meeting management support, including meeting planning, scheduling, facilitation, documentation (development of meeting agenda and minutes), and follow-up/follow-through on action items.
• Develop tools and dashboards to monitor key deliverables, decision points, risks, and critical path activities to drive delivery.
• Oversee material movement, inventory management, and liaise between internal contract/outsourcing team, technical teams, and CDMOs to coordinate contract related workstreams to ensure operational continuity.

Education

• BS/BA in a relevant drug or biological development discipline and thirteen years of related experience; or, MS/MS in a relevant drug or biological development discipline and eleven years of related experience; or, PhD in a relevant drug or biological development discipline and eight years of related experience; or, Equivalent combination of education and training.
• Advanced degree (MBA, PhD) preferred.
• Requires at least five years of CMC development or project management experience in pharmaceutical or biotech field.
• Experience managing a portfolio of multiple products, and prioritization of activities and resources.
• Experience and prior knowledge of drug development for small and large molecules.