Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE^™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).

For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role Summary:

The Sr. Director, New Product Planning is responsible for establishing and leading the New Product Planning function at Dyne. The New Product Planning function is charged with developing commercialization insights, strategies and plans for Dyne’s preclinical and early-stage clinical programs, providing commercial assessments for potential external opportunities, assisting with market preparation for late-stage programs, and contributing to strategic initiatives as needed. The role reports to Dyne’s Chief Operating Officer.

The Sr. Director, New Product Planning will be passionate about developing and commercializing life-transforming therapies for patients with severe and life-threatening muscle diseases and will develop strong knowledge of the Dyne programs (scientific and clinical data, patient population, market environment, payor landscape, etc.). The Sr. Director will be adept at operating in and building strong teams, developing effective cross-functional relationships and being able to work in a high-paced, patient-focused environment.

Key Responsibilities:

Key responsibilities include providing strategic guidance, analysis, research, and commercial assessments for Dyne’s three leading programs, early-stage research projects and potential external opportunities. More specifically to:

• Establish the foundation for the New Product Planning function at Dyne and plan for growth
• Design and execute market research for each priority disease area
• Determine patient segmentation and identify target markets
• Establish Target Product Profiles and determine early product positioning
• Provide insights into the design of key clinical trials
• Collaborate with Medical Communication and advocacy groups regarding building insights on disease burden
• Develop product value propositions
• Inform access strategies in US, EU and ROW
• Support disease and brand communication strategy
• Develop product lifecycle strategies
• Develop and manage program forecasts and valuation models
• Appropriately engage with thought leaders/ key opinion leaders
• Work with the internal cross-functional teams to develop program commercial strategies that best address the needs of patients, payers and providers and position Dyne for optimized access globally
• Present findings to cross-functional teams and, periodically, to Dyne's executive leadership

Knowledge & Skills:

• Knowledge of pharmaceutical and biotech industry trends and issues
• Knowledge of product development and life cycle
• Knowledge of FDA regulations, regulatory requirements, and clinical methodology
• Strong facilitation skills and ability to influence and negotiate positive outcomes
• Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams
• Strong analytics
• Able to work both independently and in a team-oriented, collaborative environment
• Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
• Effective collaboration skills in an environment with cross functional teams, contractors, resources, and third-party vendors

Education & Experience:

• Bachelor’s Degree required preferably in business or scientific field
• MBA or Master’s Degree preferred
• 12-15 years of experience in new product commercial support in the biopharma/ pharmaceutical industry
• Experience in rare genetic diseases
• Experience working in cross-functional teams
• Experience in new product planning, market access, strategic marketing, R&D portfolio strategy, financial forecasting and valuation, market research/analytics, and/or business development/due diligence
• Proven track record of supporting the development of innovative products

Please send resumes, and any other supporting materials, to: Careers@dyne-tx.com

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE^™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).

For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role Summary:

The position will be responsible for analytical development, analytical technology transfer and validation, and overall management of CMC activities related to external QC testing/release and stability of antibody drug conjugates and intermediates. Depending on the product phase, the Associate Director will provide both guidance and active management of analytical development and QC activities in Phase 1 thru BLA and commercial production. This will include coordinating external activities related to analytical method development and QC activities with contract development and manufacturing organizations (CDMOs), contract test labs (CTLs) and other external suppliers. S/he will also have a matrix role for research and development activities related to analytical development.

This management role will report to the VP, CMC and will work closely with key stakeholders including Development, R&D, Clinical, Regulatory Affairs, Project Management, and corporate leadership to define and build the QC capabilities required to effectively manage Dyne’s complex clinical supply chain and support eventual launch and commercialization efforts.

Primary Responsibilities Include:

• Responsible for all aspects of analytical development and QC of all intermediates, drug substance, and drug product including analytical development, validation, characterization, tech transfer, analytical method qualification, specifications, release, and stability testing
• Assist with developing the analytical/QC strategy for complex biologics/bioconjugates guided by ICH frameworks
• Partner to identify and direct external cGMP laboratories conducting raw materials, intermediate and DS/DP product testing
• Develop review and approve method transfer/validation protocols
• Perform data analysis, and generate reports supporting product release and stability programs
• Support establishment of critical quality attributes, specifications, and trend stability data to establish expiry dating of DS and DP
• Help define product analytical validation approaches
• Partner with QA to provide oversight of cGMP QC-related 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
• Work closely with R&D to support analytical development activities and enhance the tech transfer process
• Support QA compliance with cGMPs, cGLPs and guidance for clinical trial materials
• Prepare and review CMC analytically focused documentation for biologic INDs and BLAs and support FDA and EMEA interactions
• Support the development of regulatory CMC documentation and partner due diligence
• 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 10 years in QC and/or Research & Development
• Degree in biology, biochemistry, chemistry, or similar related field required
• Strong quality and analytical background with experience in general, compendial and product-specific analytical tools and practices pertinent to monoclonal antibodies, small molecules, and their mab-conjugates
• Proven experience in processes and systems to support analytical development and QC activities
• Experience authoring and supporting regulatory filings and provide technical support for responses to regulatory bodies
• Experience with managing QC external vendors required
• Strong knowledge of biologics and small molecules analytical development, quality control, and QA compliance of analytical methods 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
• Team member who can work collaboratively with colleagues across all functions
• Results oriented, establishing clear expectations and priorities, sets objectives and effectively applies resources
• Ability to set clear goals and consistently delivers
• Flexible and creative problem-solving skills
• Ability to think strategically, to see the big picture, to consistently think ahead about ways to do things better
• Logical thinker to develop and evaluates options, identifying pros and cons
• Ability to challenge current processes, practices and strategy and uncover alternative approaches, solutions, or methods
• Excellent communication and interpersonal skills with success in working across organizational boundaries at all levels to bring together people of diverse backgrounds and skill sets to create, influence, and negotiate win-win solutions
• Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Excellent organizational skills

Please send resumes, and any other supporting materials, to: Careers@dyne-tx.com

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE^™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).

For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role Summary:

Dyne Therapeutics is looking for a strategic leader to define the IT architecture and systems as the organization moves into a rapid growth phase. The opportunity for the ideal candidate will be to shape the future of technology at Dyne while ensuring the organization is built for security and scale.

Dyne Therapeutics is seeking a Director of IT to support our business as it grows into a clinical stage biotech company and prepares for a transition to a commercialized business. The ideal candidate will have 10+ years of experience with a solid understanding of Information Technology and cGXP best practices with 5+ years of computer system validation (CSV) experience in an FDA regulated industry. Areas of focus will be implementation of validated computer systems, system design, IT Architecture, workflow development, project management and desktop support. This position will be responsible for implementing and maintaining ITGC and IT SOX controls and responsible for maintaining a stable, qualified, and highly available computing infrastructure and implementation and validated computer systems. Candidates should demonstrate initiative and ability to navigate ambiguity and a willingness to grow as the company scales in size.

This is a full-time position based in Waltham, MA and reports directly to the VP, Finance.

Primary Responsibilities Include:

• Refine the current IT design and improve for scale
• Lead the design and implementation of IT infrastructure at Dyne’s new offices
• Create a scalable architecture including cloud and on-premise solutions

• Implement and manage security and compliance controls including strong vendor management
• Build and implement a multi-year scalable IT strategy and vision for the company across functions
• Provide thought leadership in architecting business applications and define an enterprise-wide integration vision and strategy for all business applications
• Partner with the Finance organization to facilitate the department’s forecasting process and ensure conformance to IT operating expense budget
• Partner with Quality Assurance and business system owners across the organization to ensure GxP computerized systems are operating effectively, efficiently, and in compliance US GxP regulations and EU guidelines
• Educate, coach, mentor and train the IT stakeholders and cost center owners on best practices and methodologies
• Be autonomous in decision making, but collaborate when needing to escalate to senior leadership team
• Serve as the single point of contact for all implemented software across the company

• Responsible for managing relationships with specific vendors and serving as the IT organization's point of contact
• Review vendor contracts and analyze proposals and quotes; review and process vendor Statements of Work and assist with creation of capital asset requests
• Support the facilitation of strategic vendor business reviews; research, interview and negotiate with vendors to obtain prices and specifications
• Conduct periodic review of software/hardware maintenance contract renewals and proactively contact vendors for quotes and submit purchase requisitions
• Proactively identify process improvements and help find efficient solutions

• Provide on-site expertise and technical knowledge of laptops, printers, and mobile computing devices
• Arrange end user on-boarding, off-boarding, provisioning, and de-provisioning
• Provide support for conference rooms

Knowledge & Skills:

• Knowledge of regulatory compliance including SEC, SOX, CFR Pt.11, EU Annex 11, cGxP, HIPAA, PDMA, GDPR and support to commercialization
• Experience supporting all levels including C-suite executives, partnering with senior leaders to identify needs and implement scalable capabilities to support their functional goals, as well as global regulatory filings
• Solid knowledge of vendor management and technology business management processes and methodologies
• Experience with software development life cycle in regulated environment
• Strong facilitation skills and ability to influence and negotiate positive outcomes
• Excellent communication skills (verbal, written, presentation) and ability to communicate well with all stakeholders and teams in person, over the phone and via email
• Able to work both independently and in a team-oriented, collaborative environment
• Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
• Effective influencing and negotiating skills in an environment with cross functional teams, contractors, resources, and third-party vendors
• Understanding of Identity based security solutions
• Cybersecurity certification preferred
• Experience with cloud technologies such as AWS, Azure
• Experience with Microsoft 365, cloud support, and experience in transitioning and implementing MS SharePoint

Education & Experience:

• Bachelor's degree or equivalent experience in technology or related field
• Ten plus (10+) years related experience
• Experience in biotech highly desirable
• Three (3) years of Budget and Vendor management domain experience preferred
• Expertise in both PC and MAC environments
• Working knowledge of HIPAA, Sarbanes-Oxley, FDA, GDPR compliance
• Experience working in a SOX environment and working with external auditors

Please send resumes, and any other supporting materials, to: Careers@dyne-tx.com

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role Summary:

Dyne is seeking a highly motivated Senior Research Associate/Research Associate in the Mechanistic Biology team based in Waltham, MA. This team member will support the DM1 program and collaborate closely with cross-functional groups to execute biological assays using a variety of readout technologies. The successful candidate will be an ambitious, motivated, energetic self-starter who enjoys working in a collaborative and fast-paced laboratory setting.

Primary Responsibilities Include:

• Provide technical support to in vitro and in vivo IND-enabling studies aimed at characterizing mechanisms of action and PK/PD profile of therapeutic candidates in relevant biological systems
• Support development of new assays to answer key muscle disease questions to ensure programs successfully progress the clinic
• Execute assays to drive optimization of the FORCE™ platform
• Communicate findings to team members and management
• Contribute to building a positive culture of teamwork and scientific excellence
• Document research efforts and maintain proper records

Education and Skill Requirements:

• BS/MS or equivalent in a biological discipline and 1-3 years of hands-on biotech/biopharma or academic experience
• Experience conducting in vivo studies with small rodents, including:
• Dosing by several routes of administration
• Tissue collection and processing for downstream assays
• Proficiency with molecular biology techniques including:
• Nucleic acid extraction and gene expression analysis by qPCR or digital PCR
• Western blots and ELISA
• Hands-on experience with standard histological protocols such as tissue-fixation, embedding, sectioning, immunofluorescence, immunohistochemistry, and in situ hybridization would be desirable
• Excellent organizational skills and ability to work in a team
• Ability to effectively communicate ideas and document research
• Experienced in the use of software applications such as Prism, Excel, and PowerPoint

Please send resumes, and any other supporting materials, to Careers@dyne-tx.com

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role Summary:

We are seeking a talented and highly motivated Scientist to join Dyne’s Mechanistic Biology group in Waltham, MA. In this position, the candidate will plan and execute studies to evaluate the efficacy, pharmacodynamics, pharmacokinetics, and mechanisms of action of antibody-drug conjugates. The successful candidate will be able to work independently and provide scientific insight in support of drug discovery efforts. The ideal candidate has an innovative mindset and enjoys working in a collaborative and fast-paced laboratory setting.

Primary Responsibilities Include:

• Execute and analyze in vitro and in vivo IND-enabling studies to characterize mechanisms of action and PK/PD profile of therapeutic candidates in relevant biological systems
• Develop new assays to answer key muscle disease questions to ensure programs successfully progress the clinic
• Contribute to the design and execution of assays to drive optimization of the FORCE™ platform
• Work effectively with the bioconjugation and preclinical/exploratory safety teams to build the strongest possible data package for the nomination of clinical development candidates
• Contribute to critical discussion of experimental design and assay development
• Present results in a clear and concise manner to senior management
• Contribute to building a positive culture of teamwork and scientific excellence
• Document research efforts and maintain proper records

Education and Skill Requirements:

• PhD in molecular biology, or related life sciences with 1-2 years of hands-on biotech/biopharma experience. BSc/MSc with 5 or more years of relevant experience will also be considered
• Ability to execute in vivo pharmacology studies with small rodents, including:
• Dosing by several routes of administration
• Tissue collection and processing for downstream assays
• Hands-on experience with in vivo assays of skeletal muscle and neuromuscular function is highly desirable
• Strong hands-on experience with standard molecular biology and histological techniques for the analysis of RNA and protein expression, including:
• Nucleic acid extraction and gene expression analysis by qPCR or digital PCR
• Protein isolation, subcellular fractionation, western blots, and ELISA
• In-situ hybridization, immunohistochemistry, and immunofluorescence
• Hands-on experience with standard histological protocols such as tissue-fixation, embedding and sectioning would be highly desirable
• Experience working with CROs would be desirable
• Effective written and oral communication skills, and ability to work efficiently in a fluid cross-functional research environment with limited supervision
• Solid research track record with relevant publications and presentations
• Proficiency in the use of software applications such as Prism, Excel, and PowerPoint

Please send resumes, and any other supporting materials, to Careers@dyne-tx.com

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role Summary:

Dyne is seeking an experienced and highly motivated scientific investigator to join Dyne’s Mechanistic Biology group based in Waltham, MA. The Principal/Senior Scientist will be accountable for the progress of carefully designed in vitro and in vivo studies to evaluate efficacy, pharmacodynamics, pharmacokinetics, and mechanism of action of antibody-drug conjugates. The successful candidate will be able to provide biological insights on new targets and therapeutic hypotheses to guide drug discovery efforts. The ideal candidate has an innovative attitude and is an ambitious self-starter who also enjoys working in a collaborative environment.

Primary Responsibilities Include:

• Independently design, execute, and analyze in vitro and in vivo IND-enabling studies to characterize mechanisms of action and PK/PD profile of therapeutic candidates in relevant biological systems
• Design, evaluate, and develop new assays to answer key muscle disease questions to ensure programs successfully progress the clinic
• Guide development of in vitro assays to drive optimization of the FORCE™ platform
• Work effectively with the bioconjugation and preclinical/exploratory safety teams to build a strong data package for the nomination of clinical development candidates
• Present results in an autonomous and effective manner to senior leadership
• Foster a positive culture of teamwork and scientific excellence
• Accountable for proper documentation of internal and external research efforts

Education and Skill Requirements:

• PhD in a modern field of biology with 2 - 3 years (Senior Scientist) or 4 - 6 years (Principal Scientist) of post-doctoral experience in a biotech/biopharma laboratory. Exceptional candidates with substantial academic experience as scientific investigators will be considered.
• Ability to design, manage, and execute in vivo pharmacology studies with small rodents and non-human primates
• Robust theoretical understanding of, and hands-on experience with, mouse models of muscle or CNS diseases is highly desirable
• Experience working with in vitro disease models using molecular biology and histological techniques including RNA and protein extraction, immunohistochemistry, immunofluorescence, in-situ hybridization, western blot, subcellular fractionation, qPCR, and ELISA
• Ability to work independently and manage multiple shifting priorities
• Experience in effectively managing CROs
• Facilitate interactions with laboratories of academic collaborators
• Strong written and oral communication skills, exceptional organizational abilities, and aptitude for collaborative work in a fluid cross-functional research environment
• Strong track record of research accomplishments with relevant publications, presentations, and/or patents
• High proficiency in the use of software applications such as Prism, Excel, and PowerPoint

Please send resumes, and any other supporting materials, to Careers@dyne-tx.com

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role Summary:

Reporting to the Vice President, Head of Preclinical Development (PCD), the Associate Director, Nonclinical Out-Sourcing will be responsible for continuing and enhancing Dyne’s partnerships with contract research organizations (CROs) and identifying areas for strategically enhancing PCD operations. The incumbent will also support multiple preclinical programs and be responsible for establishing and maintaining effective sourcing of nonclinical studies by setting clear expectations, establishing proactive and regular channels of communication, and in-person study monitoring, leading to timely delivery of high-quality study reports from CROs. The candidate should possess an in-depth understanding of Good Laboratory Practices (GLP) as they pertain to the execution and finalization of non-GLP and GLP compliant studies in support of preclinical programs. The ideal candidate should have experience as a study director/monitor on GLP compliant studies and have direct experience in working with CROs. The ability to work collaboratively with cross-functional teams is critical for this position.

Primary Responsibilities Include:

Vendor Management and Out-Sourcing Strategy

• Play a lead role in defining and expanding the scope of preclinical operations and implementing processes to gain efficiencies
• Meet with new CRO reps to assess capabilities in relation to Dyne’s needs, and build a supporting relationship between Dyne and its vendors
• Meet with CRO Business Development reps to secure pricing discounts and preferred provider status benefits
• Remain updated on CRO environment and anticipate industry trends to position Dyne as a preferred partner with CROs
• Establish quality processes for all aspects of out-sourced studies including partnering with Dyne QA to establish phase-appropriate processes for initiation of FIH-enabling studies
• Perform vendor and study staff qualification by review of facility SOPs, EIRs, and staff training records
• Lead resolution discussions between Dyne and CROs as issues arise
• Maintain metrics on study costs, discounts received, deliverable timeliness, and records of errors on outsourced studies, for communication to executive leadership
• Attend conferences to remain up to date on latest CRO capabilities and regulatory expectations

Study Coordinator/Monitor

• Align with PCD colleagues on the design and timing of studies needed to support key clinical milestones
• Obtain initial pricing for individual studies or programs from CROs and schedule studies to meet program timelines
• Work closely with relevant Dyne colleagues and CROs to coordinate and track all study-related documentation, specimen shipment, reporting timelines and archiving by maintaining appropriate file management and document control for assigned programs including timely delivery of final reports and SEND datasets
• Enable effective communication channels between CRO study directors, and other study personnel, and program toxicologists
• Travel to CROs to monitor procedures on active studies as needed and as coordinated with program toxicologists

Education and Skill Requirements:

• B.S. / M.S. or equivalent in biology, biochemistry, toxicology or a related field
• 8 or more years of experience in a biopharmaceutical company
• Experience as a study director and/or study monitor in a preclinical toxicology group
• Experience in out-sourcing of bioanalytical method development, validation and analyses is a plus
• Demonstrated understanding of GLP requirements for the conduct on toxicology studies
• Experience qualifying and/or auditing CROs for selection of executing nonclinical toxicology studies
• Experience in setting and managing budget to enable timely project execution
• Excellent communication and interpersonal skills including superior understanding of Microsoft Office products
• Willingness to travel to CROs
• Excellent organizational skills that enable the ability to manage multiple projects with attention to detail
• Capacity to complete tasks independently in a highly regulated environment
• Flexibility to function well within a team environment and within condensed timelines
• Ability to verbalize complex study issues and demonstrated problem-solving ability

Please send resumes, and any other supporting materials, to: Careers@dyne-tx.com

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.

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role:

Dyne is seeking a talented and highly motivated Research Associate/Sr. Research Associate Scientist in biology/chemistry/biochemistry to help generate and advance our therapeutics research and support our drug discovery programs. This team member will collaborate closely with in vitro/in vivo biology colleagues to generate and characterize research materials and will also have an opportunity to help establish and contribute to the operations of our laboratories.

The ideal candidate is a highly motivated individual with exceptional communication and collaboration skills. The qualified candidate will have the opportunity to build, contribute to, and expand our innovative platform technology and advance Dyne's mission of pioneering life-transforming therapies for patients with serious muscle diseases.

Primary Responsibilities Include:

• Execute research plans for the generation of research therapeutic candidates for in vitro and in vivo studies
• Analyze the stability, potency, efficacy, and purity of therapeutic materials
• Identify and screen novel targets to expand our platform to multiple therapeutic areas
• Contribute to critical discussions of therapeutic structure, function and targets

Education and Skills Requirements:

• BS or equivalent in biology/chemistry/biochemistry and 2-5 years of hands on industry experience in drug discovery and development
• Skills with chromatographic separation are a plus (e.g., SEC, HIC, IEX, LC-MS).
• Experience in cell culture and in vitro cell-based assays (multi-color flow cytometry, ELISA, reporter systems)
• Experience with high-throughput screening of candidate biologics or small molecules
• Skills with chromatographic separation are a plus (e.g., SEC, HIC, IEX, LC-MS).
• Strong organizational skills and attention to detail.
• Ability to effectively communicate ideas and document research
• Experienced in software applications (Prism, Excel, PowerPoint)
• Must be authorized to work in the United States
• Position is based in Waltham, MA - no relocation package available

Please send resumes, and any other supporting materials, to: Careers@dyne-tx.com

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role:

The Associate Director of Oligonucleotide Synthesis will report to the Head of Platform Development and is responsible for leading oligo design, manufacturing and purification at Dyne. S/he will manage internal and external oligo synthesis, analytics, and characterization of ASO and siRNA chemistries. Candidate will be a subject matter expert in the understanding of testing, scale-up and cGMP manufacturing of nucleic acid drugs with a comprehensive understanding of oligo delivery and formulations. S/he will collaborate closely with additional chemistry, biology, and research teams, supporting all stages of preclinical therapeutic development. Candidate will use creative and proactive problem-solving strategies to progress oligo design and development in support of Dyne’s therapeutic pipeline. S/he will act as an effective technical expert and work in a collaborative, constructive and mission-oriented focus for improving the lives of patients.

Education and Skills Requirements:

• PhD in Chemistry, Biochemistry, or related discipline; with 8-10 years of relevant experience in drug discovery and development.
• Strong practical knowledge of design, synthesis, and purification of nucleic acids.
• Experience in scale-up manufacturing.
• Excellent project, time management, and problem-solving skills.
• Proven leadership and interpersonal skills, including ability to work across functional lines.
• Ability to select and manage third-party vendors and collaborators, communicate technical information and work with all levels and functions within the Company.
• Excellent written and verbal communication skills, including making effective and compelling presentations in both large and small groups and communicating complex scientific and nonscientific issues to program teams.
• Ability to critically evaluate, summarize, interpret data.
• Understand published scientific literature outside of his/her immediate area of expertise and appropriately apply this understanding to company aspects
• Prepare manuscripts and other documents for publication and/or regulatory submission.

Please send resumes, and any other supporting materials, to: Careers@dyne-tx.com

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.

Company Overview:

Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. We are utilizing our proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including lead programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.

Role:

The Associate Director of Platform Expansion will report to the Head of Platform Development and is responsible for leading target discovery and expanding delivery technologies. Specifically, this person will drive the discovery, validation and prioritization of targets through internal and contract research organizations for the muscle specific delivery of therapeutic payloads. S/he will manage internal and external collaborations and generate preclinical data for the development of novel targeting modalities. Candidate will use creative and proactive problem-solving strategies to progress platform design and development to support Dyne’s therapeutic pipeline. S/he will act as an effective technical and subject matter expert and work in a collaborative, constructive and mission-oriented focus to improve the lives of patients.

Education and Skills Requirements:

• PhD in Biology, Biochemistry, or related discipline; with 8-10 years of relevant experience in drug discovery and development.
• Strong practical knowledge of target discovery and translational biology.
• Experience working with complex datasets and bioinformatic tools.
• Excellent project, time management, and problem-solving skills.
• Proven leadership and interpersonal skills, including ability to work cross-functionally.
• Ability to select and manage third-party vendors and collaborators, communicate technical information and work with all levels and functions within the Company.
• Excellent written and verbal communication skills, including making effective and compelling presentations in both large and small groups and communicating complex scientific and nonscientific issues to program teams.
• Ability to critically evaluate, summarize, interpret data.
• Understand published scientific literature outside of his/her immediate area of expertise and appropriately apply this understanding to company aspects
• Prepare manuscripts and other documents for publication and/or regulatory submission.

Please send resumes, and any other supporting materials, to: Careers@dyne-tx.com

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.