Remote Senior Director, CMC Drug Substance & Process

Superluminalrx; Boston (MA); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

401(k) match

Massachusetts transportation subsidy

Equity

Unlimited paid time off

Job summary

Superluminal Medicines seeks a Director/Senior Director to lead early-stage CMC Drug Substance development in a virtual environment. The role focuses on route scouting, process development, solid-state strategies, and regulatory documentation to enable IND readiness.

The ideal candidate has extensive experience in impurity control, GMP manufacturing, and cross-functional leadership to drive late-stage development with speed and rigor.

Qualifications

• MS or PhD in Organic Chemistry or related field.
• Proven expertise in small molecule synthesis and process development.
• Experience managing CDMOs and regulatory documentation (INDs, IMPDs).
• Strong leadership, collaboration, and communication across disciplines.

Responsibilities

• Lead route scouting and select optimal synthetic routes for scale-up.
• Develop scalable purification and solid-state processes with robust controls.
• Oversee impurity management, toxicology batch scale-up, and regulatory readiness.
• Direct CDMO partnerships and ensure on-time delivery of campaigns.
• Author regulatory sections and contribute to regulatory strategy and responses.
• Guide cross-functional teams from Drug Substance to Clinical Supply.
• Set realistic timelines for R&D, manufacturing campaigns, and IND prep.
• Communicate business value of CMC development and DoE/QbD principles.

Skills

Organic Chemistry

CDMO Management

Regulatory Documentation

Process Development

Education

MS in Organic Chemistry or related field

Job description

Superluminal Medicines seeks a Director/Senior Director to lead early-stage CMC Drug Substance development in a virtual environment. The role focuses on route scouting, process development, solid-state strategies, and regulatory documentation to enable IND readiness.

The ideal candidate has extensive experience in impurity control, GMP manufacturing, and cross-functional leadership to drive late-stage development with speed and rigor.