Senior Manager, Program Management and Drug Substance Lead

Roles and Responsibilities

• Drive day-to-day program execution across drug substance activities.
• Develop and maintain integrated timelines, track deliverables, risks, and dependencies, and ensure alignment across CMC, Quality, Regulatory, Clinical, and Supply Chain teams.
• Support drug substance activities for biologics, including CHO cell line–based processes. Contribute to process development, tech transfer, scale-up, and manufacturing readiness.
• Partner with technical teams to ensure processes are robust, scalable, and aligned with program timelines.
• Coordinate activities across CDMOs and external partners. Track manufacturing progress, ensure deliverables meet expectations, and escalate risks or issues as needed. Support preparation for manufacturing campaigns and monitor execution.
• Partner with Supply Chain to align drug substance manufacturing with clinical and commercial demand. Support planning activities, including production scheduling, inventory tracking, and risk mitigation for supply continuity.
• Identify program and technical risks and support development of mitigation plans. Work cross-functionally to resolve manufacturing, process, or supply issues in a timely manner.
• Cross-functional Collaboration: Coordinate across Quality, Regulatory, Clinical, Commercial, and Finance teams to ensure alignment on priorities, timelines, and deliverables. Support regulatory documentation and ensure consistency of CMC information.
• Maintain program plans, trackers, and dashboards using tools such as Smartsheet. Ensure timelines, risks, and decisions are accurately captured and communicated through clear updates and reporting.

Skills and Competencies

• Strong ability to manage timelines, track deliverables, and drive execution in a fast-paced environment.
• Working knowledge of biologics drug substance development, including CHO cell culture, upstream and downstream processes.
• Ability to work effectively across teams and manage competing priorities.
• Strong analytical mindset with the ability to identify risks and support practical solutions.
• Clear and organized communicator, able to provide concise updates to stakeholders.

Education, Experience and Qualifications

• Bachelor’s degree in life sciences, engineering, or related field; advanced degree preferred.
• 6–10+ years of experience in biologics drug substance development, manufacturing, or CMC program management.
• Experience with CHO cell-based manufacturing systems required.
• Experience supporting tech transfer, scale-up, and manufacturing execution.
• Experience working with external manufacturing partners (CDMOs).
• Strong program management and data management skills; experience with tools such as Smartsheet preferred.