CMC Operations Lead — Global Clinical Supply

ModeX Therapeutics Inc; Weston (MA); On-site; USD 150,000 - 230,000; Full time

Job summary

ModeX Therapeutics is seeking a Manager, Technical Operations to lead CMC operational activities supporting global clinical development programs. You will partner with internal and external partners to drive stability, supply, and testing initiatives with a focus on risk management, quality, and operational excellence.

The role emphasizes ownership, data-driven decision making, and collaboration across Regulatory, Clinical Operations, and Finance to ensure uninterrupted clinical supply and

Qualifications

• 5+ years leading CMC operations in biopharma or related field.
• Experience with regulated environments and external partners.
• Strong analytical, risk management, and project management skills.

Responsibilities

• Lead CMC operations for global clinical programs across DP, analytical, stability, packaging/labeling, storage, logistics, and distribution.
• Lead planning and execution of stability programs and shelf-life extension activities, including data review, trend analysis, risk assessment, and recommendations
• Develop and maintain DP inventory plans and supply strategies to ensure uninterrupted support of global clinical studies.
• Primary operational lead for testing, stability, and supply chain activities at CDMOs, CROs, and external partners, ensuring alignment on timelines, deliverables and quality expectations.
• Evaluate analytical and stability data to identify trends, assess operational and technical risks, and develop mitigation strategies.
• Collaborate with CMC leaders to maintain CMC operational plans, timelines, dashboards, metrics, risk registers, and management reporting.
• Lead operational readiness activities for analytical testing, clinical supply production, and distribution activities.
• Drive continuous improvement initiatives focused on operational efficiency, data management, business processes, and documentation practices.
• Lead CMC budget tracking, forecasting, PO management, and expenditure reporting, providing financial visibility to leadership.
• Identify, assess, and proactively manage supply chain challenges and operational issues that may impact timelines or availability.
• Collaborate with CMC, Clinical Operations, Program Management, Finance, and external partners to track deliverables and escalate issues to leadership.
• Support CMC activities by preparing program updates, risk assessments, mitigation plans, and decision-support materials for leadership and cross-functional teams.

Skills

CMC operations

Cross-functional leadership

Project management

Regulated environment

Education

MS/PhD in relevant field

BS with 10+ years experience

Job description

ModeX Therapeutics is seeking a Manager, Technical Operations to lead CMC operational activities supporting global clinical development programs. You will partner with internal and external partners to drive stability, supply, and testing initiatives with a focus on risk management, quality, and operational excellence.

The role emphasizes ownership, data-driven decision making, and collaboration across Regulatory, Clinical Operations, and Finance to ensure uninterrupted clinical supply and