CMC Operations Lead: Clinical Supply & Stability

ModeX Therapeutics Inc; Boston (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

ModeX Therapeutics Inc. in Boston is seeking a Manager, Technical Operations to lead CMC operational activities across global clinical development.

You will own stability programs, clinical supply strategies, and inventory plans, ensuring alignment with regulatory timelines and product development milestones. You will partner with CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners, driving risk assessments, data review, and continuous improvement while maintaining

Qualifications

• MS or PhD in Pharmaceutical Sciences, Biotechnology, Chemical Engineering, Analytical Chemistry, or a related field.
• 5+ years of biopharmaceutical industry experience supporting clinical-stage development (or BS with 10+ years).
• Demonstrated experience leading complex CMC operational activities within a regulated environment.
• Understanding of biologics development, clinical manufacturing, analytical testing, stability programs, and clinical supply operations.
• Experience supporting clinical supply planning, inventory management, batch disposition, and working with external partners.
• Proven ability to manage multiple programs and external partners while driving execution.
• Excellent communication and presentation skills for senior leadership.

Responsibilities

• Lead CMC operational activities supporting global clinical development programs across drug product, analytical, stability, packaging/labeling, storage, logistics, and distribution.
• Plan and execute stability programs and shelf-life extension activities with data review, trend analysis, and risk assessments.
• Develop and maintain DP inventory plans and supply strategies for uninterrupted global studies.
• Serve as primary operational lead for testing, stability, and supply chain activities with CDMOs and CROs; ensure alignment on timelines and quality.
• Evaluate analytical and stability data to identify trends and risks; develop mitigation strategies.
• Collaborate with CMC leaders to maintain plans, timelines, dashboards, metrics, and risk registers.

Skills

CMC operations

Regulated environment

Biologics development

Clinical supply planning

Inventory management

Documentation & change controls

Project management / leadership

Education

MS in Pharmaceutical Sciences / Biotechnology / Chemical Engineering / Analytical Chemistry or related field

PhD in Pharmaceutical Sciences / Biotechnology / Chemical Engineering / Analytical Chemistry or related field

Job description

ModeX Therapeutics Inc. in Boston is seeking a Manager, Technical Operations to lead CMC operational activities across global clinical development.

You will own stability programs, clinical supply strategies, and inventory plans, ensuring alignment with regulatory timelines and product development milestones. You will partner with CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners, driving risk assessments, data review, and continuous improvement while maintaining