Associate Director, CMC Operations - PD and Manufacturing

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 is a biotech company focusing on the cell-type specific delivery of genetic medicines. It's team of driven scientists is making a mark in delivery of oligonucleotides to extrahepatic tissues. We thrive in a purpose-building lab and office space in Watertown. Come and join us in our quest!

Position Summary:

The Associate Director of CMC Technical operations will play a key part in driving the development and manufacture of Souffle’s pipeline – serving as a technical expert and strategic leader in ligand/antibody development and manufacturing, while ensuring product quality and regulatory compliance.

Key Responsibilities:

Manufacturing Management

• Manage relationships and oversee process development and manufacturing planning and execution activities at our CDMO partner sites
• Work collaboratively to troubleshoot technical issues during development and manufacture – including deviations, CAPAs and change controls
• Author and/or review of technical documentation in support of development and manufacturing initiatives

Technical Leadership

• Provide technical oversight for development, scale-up, tech transfer, and commercial readiness activities
• Possess ability to assess and prioritize critical deliverables across multiple projects
• Serve as CMC technical lead for specific programs and cross-functional initiatives

Cross-Functional Collaboration

• Partner with Research, Preclinical, Quality, Regulatory, Program Management and other core functions to help advance program objectives
• Communicate technical information succinctly and efficiently at project team meetings

What Success Looks Like:

• In 3 months: Assess current CDMO processes and site capabilities, propose a path forward for optimization, and become the primary CMC interface for protein manufacturing and supply planning
• In 6 months: Independently drive process optimization and scale-up implementation at the CDMO site, support late-stage manufacturing partner assessment, and author for regulatory section updates
• In 12 months: Oversee completion and release of GMP batches incorporating process improvements and implementing commercial platform vision and plans. Drive late-stage tech transfer and process characterization activities

Qualifications:

• CDMO management/cGMP compliance (incl. direct owner and point for site operations, not just technical contributor)
• Strong biologics process development background (incl. media/resin screening, DoE principles, and parameter refinement to arrive at complete process) to develop processes while interacting closely with Analytical Development
• Strong manufacturing experience (incl. Tech transfer and scale up of developed processes with upstream and downstream management with breath of experience (more than a singular occurrence or pre-established process management). Downstream expertise preferred
• Experience building out internal lab capabilities and managing teams
• Experience and knowledge of Process Validation principles including qualified scale down model development, process characterization, and PPQ execution
• CMC-Reg strategy/authoring of Module 3 sections

Qualifications — Preferred:

• Experience leading programs from early stage through late-stage development, including process characterization and PPQ
• Experience building out internal lab capabilities and managing teams

Education:

• PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field with 6+ years’ experience, OR MS with 10+ years’ experience, OR BS with 12+ years’ experience

At Soufflé Therapeutics, we are intentional about building an equitable culture. How we treat our people is reflective of this focus. We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

This is an onsite position in Watertown, MA (US) with flexibility as needed for collaboration and external engagements.