Chief CMC & Technical Operations Lead

Contraline, Inc.; Charlottesville (VA); On-site; USD 250,000 - 420,000; Full time

Job summary

Contraline, Inc. seeks a Vice President / Senior Director, CMC & Technical Operations to own sponsor-side CMC strategy from Phase 3 through commercial launch.

You will lead manufacturing strategy, regulatory CMC decisions, and lifecycle management, coordinating across development, analytical, regulatory, quality, and supply functions. You will maintain IND readiness, drive submission materials, and interact with health authorities while building a robust CMC roadmap for future launches and

Qualifications

• PhD or advanced degree in a relevant scientific discipline; directly relevant experience valued.

Responsibilities

• Own sponsor-side CMC strategy from Phase 3 through commercial launch.
• Lead manufacturing strategy decisions balancing technical, regulatory, timeline, and business factors.
• Translate CMC gaps into actionable plans with priorities, timelines, owners, and decision points.
• Serve as hands-on CMC leader coordinating across development, manufacturing, analytical, regulatory, quality, supply, and commercialization activities.
• Manage sponsor-side CMC regulatory strategy including IND maintenance, health authority interactions, and submission readiness.
• Prepare, review, and maintain clear CMC source documents and submission-ready materials.
• Develop CMC strategies for regulatory meetings and phase-transition decisions.
• Own manufacturing and control strategy across drug substance, drug product, analytical methods, stability, and lifecycle management.
• Lead external manufacturers, laboratories, suppliers, and CMC consultants.
• Lead technology transfer, manufacturing campaigns, process validation, supply planning, and readiness.
• Build a CMC roadmap covering validation, stability commitments, inspection readiness, and lifecycle management.
• Translate complex CMC issues into clear executive recommendations and maintain sponsor accountability across partners.
• Assess CMC aspects of BD assets or acquisitions as needed.

Skills

CMC Strategy

Regulatory Submissions

Cross-functional Leadership

Sponsor-side Lead

External Manufacturing

Regulatory Interactions

Communication Skills

Education

PhD in Pharmaceutical Sciences or related

Job description

Contraline, Inc. seeks a Vice President / Senior Director, CMC & Technical Operations to own sponsor-side CMC strategy from Phase 3 through commercial launch.

You will lead manufacturing strategy, regulatory CMC decisions, and lifecycle management, coordinating across development, analytical, regulatory, quality, and supply functions. You will maintain IND readiness, drive submission materials, and interact with health authorities while building a robust CMC roadmap for future launches and