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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.
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Worksite address
watertown, MA, 02472, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.