CMC Operations Leader, Global Clinical Supply

BioSpace; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

ModeX Therapeutics, an OPKO Health company, is seeking a Manager, Technical Operations to provide operational leadership for CMC development and clinical supply across global programs. This role serves as the functional owner for stability and supply chain processes, driving risk management, continuous improvement, and alignment among internal and external stakeholders.

Strong technical judgment and dedication to quality are essential.

Qualifications

• Demonstrated experience leading complex CMC operational activities within a regulated environment.
• Experience coordinating with CDMOs, CROs, and external partners to meet timelines and quality targets.
• Strong project management, organizational skills, and ability to influence cross-functional teams.

Responsibilities

• Lead CMC operational activities supporting global clinical development programs across drug product, analytical, stability, packaging/labeling, storage, logistics, and distribution functions.
• Lead planning and execution of stability programs and shelf-life extension activities with data review and risk mitigation.
• Develop and maintain DP inventory plans and supply strategies to ensure uninterrupted support of global clinical studies.
• Serve as the primary operational lead for testing, stability, and supply chain activities at external partners, ensuring alignment on timelines and quality.
• Collaborate with CMC leaders to maintain operational plans, dashboards, 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, and documentation practices.

Skills

CMC operations

Cross-functional leadership

Biopharmaceuticals

Project management

Regulated environment

Stability programs

Analytical thinking

Education

MS or PhD in Pharmaceutical Sciences or related

5+ years in biopharmaceutical clinical development (or BS +10 years)

Job description

ModeX Therapeutics, an OPKO Health company, is seeking a Manager, Technical Operations to provide operational leadership for CMC development and clinical supply across global programs. This role serves as the functional owner for stability and supply chain processes, driving risk management, continuous improvement, and alignment among internal and external stakeholders.

Strong technical judgment and dedication to quality are essential.