Full-Time
Director of Quality Control
Dyne Therapeutics
201-500 employees
Develops muscle-disease therapies using FORCE platform
Compensation Overview
$190k - $230k/yr
Waltham, MA, USA
In Person
On-site role based in Waltham, Massachusetts.
 Biology & Biotech (1) |
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- Bachelor’s degree in Biology, Biochemistry, Chemistry, or related discipline; advanced degree (PhD) in Chemistry or Analytical Chemistry strongly preferred
- 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
- Demonstrated experience managing external QC laboratories and vendor performance
- Experience supporting CMC regulatory submissions from IND through BLA and commercialization
- Experience with oligonucleotide therapeutics, mass spectrometry, or bioanalytical assays is a plus
- Proven leadership experience, including building and developing teams and driving organizational effectiveness
- 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
- Highly collaborative leader who fosters cross-functional alignment and drives results in a fast-paced environment
- Quality Control Strategy & Functional Leadership Defines and executes the strategic vision for the Quality Control function to support clinical and commercial programs
- Establishes organizational structure, capabilities, and processes to support growth and future commercialization
- Participates in Pharmaceutical Quality leadership team activities, contributing to functional goals, priorities, and budgets
- Leads and develops QC personnel, including oversight of training, performance, and team development
- External Laboratory Oversight & Analytical Operations Oversees external QC laboratories, including testing execution, data analysis, and issuance of Certificates of Analysis
- 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
- Quality Systems, Compliance & Technical Execution Reviews and approves analytical method qualification and validation protocols and reports
- 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
- Authors, reviews, and approves QC standard operating procedures
- Regulatory, Inspection Readiness & Cross-Functional Collaboration Prepares and reviews analytical CMC content for regulatory submissions (INDs, BLAs) and supports interactions with global health authorities
- Participates in regulatory inspections and ensures inspection readiness across QC activities
- Collaborates closely with Quality Assurance, Manufacturing, CMC, Supply Chain, Regulatory Affairs, and Project Management to align quality and program objectives
- Oversees stability and reference standard programs to ensure compliance with regulatory expectations
Dyne Therapeutics develops therapies for serious muscle diseases using its FORCE™ platform, which helps deliver oligonucleotide medicines to muscle tissue. Through a portfolio of experimental therapies, the company advances them in clinical trials (ACHIEVE and DELIVER) with the aim of treating rare muscle diseases. The product works by enhancing targeted delivery of oligonucleotides to muscle, enabling existing genetic medicines to reach affected tissues more effectively. Dyne differentiates itself by its proprietary FORCE™ technology and its focus on rare muscle diseases, positioning itself for growth as trials progress toward potential commercialization. The company’s goal is to bring effective treatments to patients and families affected by serious muscle diseases, expanding options as its therapies advance through development and, potentially, regulatory approval.
Company Size
201-500
Company Stage
IPO
Headquarters
Waltham, Massachusetts
Founded
2017
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Simplify's Take
What believers are saying
- Preclinical data shows sustained dystrophin expression and muscle function improvement after single low dose[1].
- ACHIEVE trial shows dose-dependent splicing correction and functional improvement in DM1 patients[3].
- Dyne secured $400M debt facility to support US launches of DMD and DM1 therapies within two years[3]
What critics are saying
- Sarepta's upadacersen dominates DMD market with 80% adoption, blocking Dyne's switch opportunities in 12–18 months
- FDA rejection risk for accelerated approval due to inadequate Phase 1/2 data persists in 6–12 months
- Dyne faces insolvency within 12 months if FDA denies approval due to $200M debt and equity dilution
What makes Dyne Therapeutics unique
- Dyne's FORCE™ platform targets TfR-1 for precise oligonucleotide delivery to muscle and CNS[1][2].
- Dyne pioneers low-dose, infrequent therapy for DM1 using FORCE™ platform validation[4][6].
- Dyne advances clinical programs for DMD and DM1 with fast track and orphan drug designations[3].
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Growth & Insights and Company News
6 month growth
↓ -4%1 year growth
↑ 0%2 year growth
↓ -3%(Nasdaq: DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced the pricing of an upsized underwritten public offering of 18,980,478 shares of its common stock at a public offering price of $18.44 per share.