Director, Quality Control
Job Location:
Waltham, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) Pompe disease and multiple DMD mutations. At Dyne we are on a mission to deliver functional improvement for individuals families and communities. Learn more at and follow us onXLinkedInandFacebook.
Role Summary:
This is an onsite role based in Waltham MA.
Primary ResponsibilitiesInclude:
- 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:
- Bachelors 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
MA Pay Range
$190000 - $230000 USD
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.
Required Experience:
Director
About Company
Repairing muscle, reclaiming now. Life-transforming therapies for inherited muscle diseases.
