CMC Ops Lead, Biologics Process Development & Tech Transfer

Soufflé Therapeutics; Watertown (MA); On-site; USD 170,000 - 230,000; Full time

Job summary

Soufflé Therapeutics seeks an Associate Director of CMC Technical Operations to drive development and manufacturing of its pipeline. The role provides technical leadership in ligand/antibody development, scale-up, tech transfer, and regulatory readiness.

Collaboration with Research, Quality, and Regulatory is essential to deliver GMP-compliant processes. The ideal candidate has a strong biologics background, experience leading CDMO partnerships, and a track record of delivering late-stage

Qualifications

• PhD or equivalent with extensive CMC ops experience (6+ years) or MS/BS with relevant years.
• Strong track record in biologics development, manufacturing and scale-up.
• Experience authoring and reviewing technical regulatory documentation.
• Demonstrated capability to lead cross-functional teams and manage CDMOs.

Responsibilities

• Oversee CDMO management and manufacturing planning at partner sites.
• Provide technical oversight for development, scale-up, tech transfer, and readiness.
• Collaborate with Research, Quality, Regulatory, and Program Management to advance programs.
• Drive process optimization and scale-up at CDMO sites and support regulatory updates.
• Ensure GMP batch release after implementing process improvements and tech transfer.

Skills

Biologics process development

Tech transfer & scale-up

CDMO management

Team leadership

Regulatory documentation

Education

PhD in Chemistry / Chemical Engineering / Pharmaceutical Sciences (6+ yrs)

MS (10+ yrs)

BS (12+ yrs)

Job description

Soufflé Therapeutics seeks an Associate Director of CMC Technical Operations to drive development and manufacturing of its pipeline. The role provides technical leadership in ligand/antibody development, scale-up, tech transfer, and regulatory readiness.

Collaboration with Research, Quality, and Regulatory is essential to deliver GMP-compliant processes. The ideal candidate has a strong biologics background, experience leading CDMO partnerships, and a track record of delivering late-stage