Associate Director, Analytical Development

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:

The Associate Director Analytical Development Oligonucleotides leads analytical development and supports quality control strategies for oligonucleotide and small-molecule intermediates across clinical development registration and commercialization. This role provides strategic and technical leadership for analytical method development validation technology transfer specifications release testing stability programs impurity control and product characterization.

The Associate Director independently leads multiple analytical workstreams and makes decisions that influence program strategy product quality regulatory submissions and clinical supply. The role provides oversight of CDMOs contract testing laboratories and other external partners to ensure analytical activities meet scientific regulatory quality timeline and business requirements.

Working closely with CMC Quality Regulatory Affairs Supply Chain Research and Development Clinical and Project Management this position establishes analytical priorities resolves complex technical issues manages program risks and guides cross-functional decision-making. The Associate Director also serves as an analytical subject matter expert mentors colleagues and strengthens analytical capabilities and practices across the organization.

This is a full-time position based in Waltham MA without the possibility of being remote. Physical presence onsite is expected on 4-5 days/week.

Primary Responsibilities Include:

• Lead analytical development and quality control strategies for oligonucleotide and small-molecule intermediates from early clinical development through commercialization
• Serve as the analytical SME and strategic lead for internal and external activities related to analytical operations of linkers and oligonucleotide intermediates
• Responsibilities will include aspects of analytical development of drug substance intermediates including method development validation characterization tech transfer specifications release and stability testing
• Assist with developing the analytical/QC strategy for small molecules and oligonucleotides guided by ICH framework
• Develop review and approve method transfer/validation protocols and validation approaches
• Support establishment of critical quality attributes and phase-appropriate specifications
• Advise and plan extended characterization of drug substance intermediates to expand product understanding
• Partner with QC and QA to provide oversight of cGMP activities and documents (change controls deviations CAPAs procedures QC raw data review batch release support stability protocols and programs validation protocols etc.)
• Oversee Reference Standard program including establishing and maintaining reference standards approving qualification protocols and reports and coordinating release testing at external laboratories as appropriate
• Lead author approve or provide strategic direction for CMC analytically focused documentation for biologic INDs and BLAs and support FDA and EMEA interactions
• Work with partner organizations as necessary to ensure that timelines are met milestones and products are delivered on schedule and any excursions deviations investigations and CAPAs are initiated addressed and closed within target timeframes

Education and Skills Requirements:

• A minimum of 8 years in Analytical Development and/or Quality Control
• Bachelors or masters degree in biology biochemistry chemistry or similar related field required
• Knowledge of a variety of analytical techniques including liquid and gas chromatography NMR Karl Fischer CD AEX chiral separations RP-HPLC and mass spectroscopy
• Strong quality and analytical background with experience in general compendial and product-specific analytical tools and practices pertinent to small molecules and oligonucleotides.
• Experience with monoclonal antibodies or ADCs (mab-conjugates) and relevant analytical techniques a plus
• Experience with impurity control strategy including novel approaches for impurity detection impurity ID and characterization for oligonucleotides/ small molecules
• Experience with managing external vendors required
• Experience in all phases of CMC regulatory submissions and interactions regarding CMC issues ideally including post-approval experience international experience and negotiation experience with regulatory authorities
• Strong knowledge of cGMP/ICH/FDA/EU regulations
• Ability to challenge current processes practices and strategy and uncover alternative approaches solutions or methods
• Excellent interpersonal organizational negotiation and communication skills; a team member than can work collaboratively with colleagues across functions
• Ability to travel (up to 10%)

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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.