Dyne Therapeutics
Director, Quality Control
Waltham, MA · Director
Sponsorship not specified$190k-$230kDetected 16 days ago
Data AnalysisProject ManagementNegotiationSupply ChainGMPFDA RegulatoryMass SpectrometryProtein AnalysisAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs
About the role
- Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases.
- The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease.
- Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Responsibilities
- Establishes organizational structure, capabilities, and processes to support growth and future commercialization
- Leads and develops QC personnel, including oversight of training, performance, and team development
- Defines, tracks, and trends laboratory performance metrics (e.g., quality, capacity, turnaround time, non-conformances) to drive partner accountability and continuous improvement
- Leads analytical troubleshooting efforts in collaboration with contract laboratories
- Ensures alignment of external partners with program timelines to enable product disposition
- Authors, reviews, and approves stability protocols and reports and supports assignment of product expiry
- Supports establishment of critical quality attributes (CQAs) and product specifications for Drug Substance (DS) and Drug Product (DP)
- Partners with QA to ensure effective oversight of cGMP QC activities, including change control, deviations, investigations, CAPAs, and batch disposition support
- Leads Out of Specification (OOS) and Out of Trend (OOT) investigations
- Collaborates closely with Quality Assurance, Manufacturing, CMC, Supply Chain, Regulatory Affairs, and Project Management to align quality and program objectives
Requirements
- 12+ years of experience in Analytical Development and/or Quality Control within a GMP-regulated environment
- Strong expertise in analytical techniques (e.g., SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA)
- Deep knowledge of cGMP regulations and global guidance (FDA, ICH, EU)
- Experience with compendial and product-specific analytical methods for biologics and/or small molecules
- Experience supporting CMC regulatory submissions from IND through BLA and commercialization
- Strong strategic thinking and problem-solving capabilities with the ability to translate strategy into execution
- Excellent interpersonal, communication, and negotiation skills with the ability to influence internal and external stakeholders
Nice to have
- Bachelor's degree in Biology, Biochemistry, Chemistry, or related discipline
- advanced degree (PhD) in Chemistry or Analytical Chemistry strongly preferred
- Experience with oligonucleotide therapeutics, mass spectrometry, or bioanalytical assays is a plus
Compensation
- $190,000 - $230,000 USD
Benefits
- Defines and executes the strategic vision for the Quality Control function to support clinical and commercial programs
- Prepares and reviews analytical CMC content for regulatory submissions (INDs, BLAs) and supports interactions with global health authorities
Company info
- We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease.
- At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.
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