- Location
- Waltham, MA · Waltham, Massachusetts, United States
- Workplace
- Onsite
- Department
- 1320GL - Quality
- Seniority
- Director
- Experience
- 12+ years
- Education
- PhD
- Source
- Greenhouse
Description
Company Overview:
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. 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. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
Role Summary:
This is an onsite role based in Waltham, MA.
Primary Responsibilities Include:
- 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
- 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
- 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
- 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
Education and Skills Requirements:
-
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
#LI-Onsite
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
