Associate Director, CMC Operations - PD and 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 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.