What are the responsibilities and job description for the Senior Director, Quality Control position at Soufflé Therapeutics?
Soufflé Therapeutics | Senior Director, Quality Control | 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 Senior Director, QC provides scientific and operational leadership for all QC activities supporting a pipeline spanning monoclonal antibodies (mAbs), RNA therapeutics (mRNA, siRNA, ASOs), and oligo‑antibody conjugates. In a virtual operating model where testing, development, and manufacturing are outsourced, this leader will establish governance with CDMOs/CROs, oversees analytical strategy, and manages method lifecycle requirements.
Key Responsibilities
- Lead QC strategy across antibodies, RNA, and conjugate modalities.
- Drive modality‑specific analytical approaches including glycan profiling, potency assays, RNA integrity/capping analysis, and DAR characterization.
- External QC Oversight
- Provide governance of QC testing at CDMOs/CROs.
- Review partner QC deliverables including CoAs, OOS/OOT investigations, and stability data.
- Drive external CDMO/CRO schedules to achieve overall project schedules
- Method Lifecycle Management
- Oversee transfer, qualification, validation, and maintenance of analytical methods across all modalities.
- Regulatory Compliance
- Ensure QC activities align with cGMP, ICH, FDA, EMA expectations.
- Support QC sections of regulatory submissions.
- Product Quality & Release
- Oversee external testing and release of mAb, RNA, and conjugated DS/DP.
- Stability Program Oversight
- Manage outsourced stability programs for biologics and RNA products.
- Drive external CDMO/CRO schedules to achieve overall project schedules
- Organizational Leadership
- Build and manage a lean QC function optimized for a virtual environment.
Qualifications
- 12 years QC/analytical experience across biologics and/or RNA
- 3 years’ experience overseeing outsourced QC and CDMO partners.
- Experience with SiRNA and mBA analysis is an advantage
- Experience with commercial Quality Control is a must
Additional Information
- Travel: ~15–30% to partner sites.
At Soufflé Therapeutics, we are intentional about building an equitable culture.
This is an onsite position in Watertown, MA with flexibility as needed for collaboration and external engagements. We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.