Director, Quality Control

Responsibilities

• Define and execute the strategic vision for the Quality Control function to support clinical and commercial programs
• Establish organizational structure, capabilities, and processes to support growth and future commercialization
• Oversee external QC laboratories, including testing execution, data analysis, and issuance of Certificates of Analysis
• Define, track, and trend laboratory performance metrics to drive partner accountability
• Lead analytical troubleshooting efforts in collaboration with contract laboratories
• Review and approve analytical method qualification and validation protocols and reports
• Author, review, and approve stability protocols, reports, and QC standard operating procedures
• Partner with QA to ensure effective oversight of cGMP QC activities, including change control, deviations, and CAPAs
• Lead Out of Specification (OOS) and Out of Trend (OOT) investigations
• Prepare and review analytical CMC content for regulatory submissions (INDs, BLAs)
• Participate in regulatory inspections and ensure inspection readiness

Requirements

• Bachelor’s degree in Biology, Biochemistry, Chemistry, or related discipline (PhD strongly preferred)
• 12+ years of experience in Analytical Development and/or Quality Control within a GMP-regulated environment
• Strong expertise in analytical techniques such as SEC, AEX, RP-HPLC, CE-SDS, icIEF, and ELISA
• Deep knowledge of cGMP regulations and global guidance (FDA, ICH, EU)
• Experience managing external QC laboratories and vendor performance
• Experience supporting CMC regulatory submissions from IND through BLA and commercialization
• Proven leadership experience in building and developing teams

Preferred Qualifications

• Experience with oligonucleotide therapeutics, mass spectrometry, or bioanalytical assays

About the Company

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases by developing therapeutics that target muscle and the central nervous system (CNS).