Associate Director, Analytical Development

Dyne Therapeutics•Waltham, MA

3d•$160,000 - $200,000•Onsite

About The Position

The Associate Director, Analytical Development leads analytical development and supports quality control strategies for oligonucleotides and small-molecule intermediates across clinical development, registration, and commercialization. The 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 oversees CDMOs, contract testing laboratories, and other external partners to ensure analytical activities meet scientific, regulatory, quality, timeline, and business requirements. Working across CMC, Quality, Regulatory Affairs, Supply Chain, Research and Development, Clinical, and Project Management, the position establishes analytical priorities, resolves technical issues, manages program risks, and guides cross-functional decisions. 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 onsite in Waltham, Massachusetts, with no remote-work option. Onsite presence is expected 4–5 days per week, and travel may be required up to approximately 10%.

Requirements

At least 8 years of experience in Analytical Development and/or Quality Control.
Bachelor’s or master’s degree in biology, biochemistry, chemistry, or a similar related field.
Knowledge 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 relevant to small molecules and oligonucleotides.
Experience developing impurity control strategies, including novel approaches to impurity detection, identification, and characterization for oligonucleotides and small molecules.
Experience managing external vendors.
Experience with all phases of CMC regulatory submissions and interactions regarding CMC issues.
Strong knowledge of cGMP, ICH, FDA, and EU regulations.
Ability to challenge current processes, practices, and strategies and identify alternative approaches, solutions, or methods.
Excellent interpersonal, organizational, negotiation, and communication skills, with the ability to collaborate across functions.
Ability to travel up to approximately 10%.

Nice To Haves

Experience with monoclonal antibodies or ADCs (mab-conjugates) and relevant analytical techniques.
CMC regulatory experience that includes post-approval, international, and negotiation experience with regulatory authorities.

Responsibilities

Lead analytical development and quality control strategies for oligonucleotide and small-molecule intermediates from early clinical development through commercialization.
Serve as the analytical subject matter expert and strategic lead for internal and external analytical operations involving linkers and oligonucleotide intermediates.
Lead analytical development of drug substance intermediates, including method development, validation, characterization, technology transfer, specifications, release, and stability testing.
Help develop analytical and QC strategies for small molecules and oligonucleotides guided by the ICH framework.
Develop, review, and approve method transfer and validation protocols and validation approaches.
Support establishment of critical quality attributes and phase-appropriate specifications.
Advise on and plan extended characterization of drug substance intermediates to expand product understanding.
Partner with QC and QA to oversee cGMP activities and documents, including change controls, deviations, CAPAs, procedures, QC raw data review, batch release support, stability protocols and programs, and validation protocols.
Oversee the 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 analytically focused CMC documentation for biologic INDs and BLAs, and support FDA and EMEA interactions.
Work with partner organizations to meet timelines and milestones, deliver products on schedule, and ensure excursions, deviations, investigations, and CAPAs are initiated, addressed, and closed within target timeframes.
Work cross-functionally to establish analytical priorities, resolve technical issues, manage risks, and guide decision-making.
Mentor colleagues and strengthen analytical capabilities and practices across the organization.