Associate Director, Analytical Development

Dyne Therapeutics, Inc.; Waltham (MA); On-site; USD 160,000 - 200,000; Full time

Job summary

Dyne Therapeutics, Inc. in Waltham, MA, is seeking an Associate Director, Analytical Development to lead analytical development and QC strategies for oligonucleotide and small-molecule intermediates across clinical development through commercialization.

This role partners with CMC, Quality, Regulatory Affairs, and external labs, providing strategic leadership and oversight of analytical programs. The position requires at least 8 years in analytical development/QA, advanced degree in biology or

Qualifications

• Minimum 8 years in Analytical Development and/or Quality Control.
• Degree in biology, biochemistry, chemistry or related field.
• Experience with cGMP and regulatory expectations.
• Knowledge of analytical techniques including LC/GC, NMR, Karl Fischer, CD, AEX, chiral separations, RP-HPLC and MS.

Responsibilities

• Lead analytical development and QC strategies from early clinical development through commercialization.
• Serve as analytical SME for internal and external activities related to analytical operations of linkers and oligonucleotide intermediates.
• Responsibilities include method development, validation, transfer, specifications, release and stability testing.
• Develop and implement QC strategy for small molecules and oligonucleotides per ICH framework.
• Oversee cGMP documents, change controls, deviations, CAPAs, batch release support, and stability programs.

Skills

Analytical Development

Quality Control

Regulatory Submissions

Team Collaboration

Education

Bachelor’s or Master’s in Biology/Chemistry/Biochemistry

Tools

LC/LC-MS

NMR

Karl Fischer

RP-HPLC

Chiral separations

CD

Job description

Associate Director, Analytical Development

Waltham, MA

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 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 https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

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
• Bachelor’s or master’s 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%)

MA Pay Range

$160,000 - $200,000 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.

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Dyne Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

• A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.
• A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
• An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
• An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.