Director, Drug Substance Development & CDMO Partnerships

Treeline; Watertown (MA); On-site; USD 180,000 - 240,000; Full time

Job summary

Treeline seeks a Director, Chemical Development to lead development and manufacturing activities for drug substance and starting materials within a 100% outsourced model. The role covers process development, scale-up, PPQ, and collaboration with CDMOs to ensure supply continuity and regulatory readiness for IND/IMPD submissions.

The candidate will oversee cross-functional teams, drive technical transfer, ensure QA and regulatory interface, author technical documents, and travel 20% to CDMO sites

Qualifications

• Ph.D. in Organic Chemistry or related discipline with 12+ years in chemical development of small-molecule pharmaceuticals.
• Demonstrated success leading pharmaceutical CMC drug substance development in outsourced environments.
• Strong vendor/CDMO management and cross-functional collaboration skills.
• Expertise in authoring development reports and regulatory submissions.

Responsibilities

• Lead cross-functional teams engaged in external cGMP manufacturing of drug substance and starting materials.
• Collaborate with medicinal chemistry to support candidate selection and developability assessments.
• Provide technical and functional project leadership on drug substance process development and CDMO partner management.
• Oversee tech transfer and ensure supply continuity.
• Author and review technical documents for IND/IMPD and global filings.
• Stay current with global regulations and industry standards.
• Represent Drug Substance Development in regulatory interactions and with FDA/EMA.
• May supervise one or more process chemists.

Skills

Leadership

CDMO management

Regulatory writing

Cross-functional collaboration

Project leadership

Vendor management

Education

Ph.D. in Organic Chemistry (12+ yrs)

M.S. in Chemistry (15+ yrs)

Tools

JMP

MS Word

Excel

PowerPoint

MS Project

Job description

Treeline seeks a Director, Chemical Development to lead development and manufacturing activities for drug substance and starting materials within a 100% outsourced model. The role covers process development, scale-up, PPQ, and collaboration with CDMOs to ensure supply continuity and regulatory readiness for IND/IMPD submissions.

The candidate will oversee cross-functional teams, drive technical transfer, ensure QA and regulatory interface, author technical documents, and travel 20% to CDMO sites