Principal Scientist, Analytical Development

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:

The position will support and oversee analytical method development, method transfer and qualification, and overall management of CMC activities related to internal and external analytical testing and stability of antibody drug conjugates and intermediates. The Principal Scientist will lead analytical development for several preclinical programs, and direct method qualification for use in GMP production of clinical materials (Phase 1-3) with guidance from analytical leadership. This includes identification, selection, and setup of a central testing lab (CTL), and coordinating external activities related to analytical method development at the CTL and at various manufacturing organizations (CDMOs). This role works closely with key stakeholders within Technical Operations as well as across the company including Platform Research, Regulatory, and Project Management.

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

Primary Responsibilities Include:

• Oversight of all analytical aspects for bioconjugate drug substance and drug product as well as support for PMO and ASO oligonucleotides and small molecule intermediates including analytical method development, product quality characterization, technology and method transfer, analytical method qualification, in-process and release testing, and stability programs.
• Assist with developing the analytical strategy for complex biologics/bioconjugates guided by ICH frameworks.
• Identify and direct external cGMP laboratories conducting raw materials, intermediate and DS/DP product testing.
• Work with partner organizations and internal quality as necessary to ensure that timelines are met, milestones and products are delivered on schedule, and any excursions, deviations, OOS/OOT investigations, and CAPAs are initiated, addressed, and closed within target timeframes.
• Develop, review and approve method transfer/validation protocols and validation approaches.
• Author and review change controls, risk assessments and product specifications.
• Manage external CMOs and CTLs for the transfer and validation of analytical methods, product characterization testing and product release/stability testing.
• Advise and plan extended characterization of intermediates and drug substance to expand product understanding and impurity characterization.
• Support establishment of critical quality attributes, specifications, and overall control strategy.
• Partner with QA to provide oversight of cGMP-related activities and documents (change controls, deviations, CAPAs, procedures, batch release support, stability protocols and programs etc.)
• Support Reference Standard program including establishing and maintaining reference standards, approving qualification protocols and reports, and coordinating release testing at external laboratories as appropriate.
• Support the development of regulatory CMC documentation including INDs, IMPDs and BLA as well as RTQs.
• Support internal analytical wet lab work as needed and the development and expansion of the internal AD/CMC lab.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline.
• Minimum of 8 years of experience in Analytical Chemistry preferably in a clinical-stage biotechnology company.
• Knowledge and hands-on experience with a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, GC, and mass spectroscopy.
• Strong experience with bioconjugates/ADCs a plus.
• Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment.
• Excellent interpersonal, organizational, negotiation, and communication skills; a team member that can work collaboratively with colleagues across functions.

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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.