Associate Director, CMC Operations & PD — Manufacturing

Soufflé Therapeutics; Watertown (MA); On-site; USD 180,000 - 230,000; Full time

Job summary

Soufflé Therapeutics in Watertown, MA, is seeking an Associate Director of CMC Technical Operations to lead the development and manufacturing of our biologics pipeline. This role provides technical leadership and strategic direction, ensuring product quality and regulatory compliance across CDMO partnerships and internal programs.

You will oversee process development, tech transfer, and scale-up, collaborating with Research, Quality, Regulatory, and Program Management to advance programs from

Qualifications

• Experience in CDMO management and cGMP compliance in biologics.
• Strong biologics process development background including DoE and parameter refinement.
• Proven track record in tech transfer and scale-up of developed processes.
• Experience building internal lab capabilities and leading teams.
• Knowledge of PPQ, Process Validation, and regulatory submissions.
• Ability to lead cross-functional programs from development to readiness.

Responsibilities

• Oversee CDMO management and manufacturing planning/execution with partners.
• Provide technical oversight for development, scale-up, tech transfer, and regulatory readiness.
• Collaborate with Research, QA, Regulatory, and Program Management to advance programs.
• Communicate technical information clearly at project team meetings.

Skills

CDMO management

cGMP compliance

Biologics process development

Tech transfer

Process validation

Regulatory strategy

Education

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

MS in a related field with 10+ years of experience

BS in a related field with 12+ years of experience

Job description

Soufflé Therapeutics in Watertown, MA, is seeking an Associate Director of CMC Technical Operations to lead the development and manufacturing of our biologics pipeline. This role provides technical leadership and strategic direction, ensuring product quality and regulatory compliance across CDMO partnerships and internal programs.

You will oversee process development, tech transfer, and scale-up, collaborating with Research, Quality, Regulatory, and Program Management to advance programs from