CMC Operations Manager: Stability & Global Clinical Supply

BioSpace; Weston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

ModeX Therapeutics, an OPKO Health company based in Weston, MA, seeks a Manager of Technical Operations to lead CMC development and clinical supply activities across global programs. You will own stability and supply strategies, manage external partners, and drive risk-based decision making to ensure uninterrupted clinical supply and regulatory readiness.

The role emphasizes strong leadership, data-driven planning, and collaboration with CMC, Quality, Regulatory, and Clinical Operations to

Qualifications

• MS or PhD in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Analytical Chemistry, or a related scientific discipline, with 5+ years of biopharmaceutical industry experience supporting clinical-stage development programs; or a BS in a related scientific discipline with 10+ years of relevant industry experience.

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, including data review, trend analysis, risk assessment, and recommendations to support program decisions.
• 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 CDMOs, CROs, and other external partners, ensuring alignment on timelines, deliverables, and quality expectations.

Skills

Project management

Cross-functional collaboration

Strategic planning

Data-driven decisions

Communication & presentation

Education

MS or PhD in Pharmaceutical Sciences / Biotechnology / Chemical Engineering / Analytical Chemistry

BS in a related field with 10+ years experience

Job description

ModeX Therapeutics, an OPKO Health company based in Weston, MA, seeks a Manager of Technical Operations to lead CMC development and clinical supply activities across global programs. You will own stability and supply strategies, manage external partners, and drive risk-based decision making to ensure uninterrupted clinical supply and regulatory readiness.

The role emphasizes strong leadership, data-driven planning, and collaboration with CMC, Quality, Regulatory, and Clinical Operations to