Global CMC Operations Lead, Clinical Supply

ModeX Therapeutics Inc.; Weston, Northern (MA, KY); Hybrid; USD 135,000 - 150,000; Full time

Job summary

ModeX Therapeutics in Weston, MA is seeking a Manager, Technical Operations to provide operational leadership for CMC development and clinical supply activities across global programs. The role owns key processes related to stability, supply chain, and outsourcing, ensuring quality and timely delivery.

The ideal candidate will oversee risk management, continuous improvement, and collaboration with internal teams and external partners.

Qualifications

• Advanced degree in life sciences with relevant clinical-stage CMC experience.
• Experience leading complex CMC operational activities in regulated settings.
• Knowledge of biologics development, clinical manufacturing, analytical testing, and stability.
• Experience with budget management, forecasting, and vendor partnerships.

Responsibilities

• Lead CMC operational activities across drug product, analytical, stability, packaging, and logistics.
• Plan and execute stability programs, data review, trend analysis, and risk assessments.
• Develop DP inventory plans and supply strategies for global clinical studies.
• Coordinate with CDMOs, CROs, and partners to ensure timelines and quality.
• Monitor performance, resolve issues, and support leadership reviews.
• Maintain CMC plans, dashboards, metrics, and risk registers for decision-making.
• Lead operational readiness for analytical testing and clinical supply production.

Skills

CMC operations leadership

Cross-functional coordination

Budget management and forecasting

Project management

Regulated environment experience

Education

MS or PhD in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Analytical Chemistry, or related discipline

BS in a related scientific discipline with 10+ years of industry experience

Job description

ModeX Therapeutics in Weston, MA is seeking a Manager, Technical Operations to provide operational leadership for CMC development and clinical supply activities across global programs. The role owns key processes related to stability, supply chain, and outsourcing, ensuring quality and timely delivery.

The ideal candidate will oversee risk management, continuous improvement, and collaboration with internal teams and external partners.