Scientist, Analytical Development & Quality Control

Company Overview:

Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.

Role Summary:

The Scientist, Analytical Development & Quality Control is responsible for analytical development, feasibility, method qualification, routine, and stability testing of antibody drug conjugates and intermediates. The person is this role will lead daily lab operations while supporting CMC process development. This role works closely with key stakeholders including CMC, Supply Chain, Development, R&D, Clinical, Regulatory Affairs and Project Management to define the analytical capabilities required to effectively manage Dyne's complex clinical supply chain and support eventual launch and commercialization efforts.

This role is based Waltham, MA without the possibility of being a remote role. Applicants must be able to relocate to the area.

Primary Responsibilities Include:

• Development, optimization, qualification, transfer, validation, and routine execution of analytical methods for proteins, mAbs, drug conjugates using techniques pertinent to LC (SEC, RP, IEX), LCMS, ELISA, CE-SDS, icIEF, and other wet chemistry techniques.

• Lead and manage daily lab operations for analytical testing and support CMC process development

• Execute and test development and non-GMP stability samples in-house

• Partner with research to support early-stage development and adapt methodology to be suitable for GMP testing

• Preparation and review of analytical test methods, standard wok instructions, technical documents, protocols, reports, etc.

• Documentation of work in laboratory notebooks (paper based) and logbooks according to organizational GDP policies

• Maintenance, cleaning, calibration, troubleshooting and repair of analytical instruments and equipment

• Management of work carried out by third-party analytical and metrology service providers

• Adhere to organizational EHS policies and maintain work areas in a safe and clean environment

• Peer review of analytical data

Education and Skills Requirements:

• Bachelor's or master's degree in biology, biochemistry, chemistry, or similar related field required

• A minimum of 3-5 years in Analytical Development and/or Quality Control preferably in a clinical stage biopharmaceutical company

• Hands-on experience and knowledge of a variety of analytical techniques including SEC, AEX, RP-HPLC, CE-SDS, icIEF, ELISA, and mass spectroscopy

• Strong chemistry and analytical background with experience in general, compendial and product-specific analytical tools and practices pertinent to one or more of monoclonal antibodies, small molecules, oligonucleotides and/or mab-conjugates

• Experience working with CDMOs and external QC vendors

• Familiarity with 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

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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.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

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.