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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Role Summary:

The position is responsible for process development, technology transfer, and management of external CDMO activities to ensure development of robust and reliable GMP manufacturing processes for antibody oligonucleotide conjugates and intermediates. The Senior Scientist will represent CMC Process Sciences as a technical leader and provide guidance to internal process development staff and external vendors on oligonucleotide conjugate development and manufacturing activities from pre-clinical to GMP production for clinical evaluation (Phase 1-3). This includes active oversight of process establishment, process development, scale-down model verification, and process characterization. This person will also have direct oversight of CDMO technology transfer and process development operations.

This position works closely with key stakeholders including Platform Research, External Manufacturing, Regulatory Affairs, and Project Management to meet the needs of Dyne’s complex clinical supply chain, supporting our preclinical and clinical programs.

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:

• Responsible for drug substance bioconjugation including process development, tech transfer, scale-up, and process characterization of oligonucleotide conjugates.
• Lead internal CMC Process Development activities via hands-on contribution in the laboratory.
• Work with CDMOs to manage external process development, optimization, and tech transfer of new programs in a stage appropriate manner to ensure key milestones and products are delivered on schedule.
• Partner with Research to support bioconjugation development activities and enhance the tech transfer process to external manufacturing partners.
• Represent bioconjugation Drug Substance process as a technical leader in internal cross-functional CMC teams.
• Establish clear expectations and priorities, set objectives, and effectively apply resources to deliver on program goals.
• Select, qualify and manage external contract development and manufacturing organizations.
• Drive continuous improvement opportunities, adapt to and solve challenges and lead the timely resolution of issues.
• Evaluate and implement emerging technologies/applications to improve conjugation processes and optimize purification methods.
• Partner with internal cross functional teams and serve as the liaison to define suitable, compliant, and defendable CMC strategies.
• Prepare technical source documents, publications, and oral presentations.
• Prepare and review relevant CMC and product related sections and documentation for global regulatory submission.
• Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and a minimum of 5+ years related experience working with bioconjugates including a deep understanding of conjugation chemistries, preparative chromatography, and TFF. 
• Experience in biopharmaceutical CMC management and/or Research & Development preferably in a clinical-stage biotechnology company.
• Familiarity working with oligonucleotides including but not limited to morpholino oligonucleotides, antisense oligonucleotides, and siRNA is desired.
• Hands on experience with analytical techniques for characterization of conjugates including HPLC/UPLC, SEC, SDS-PAGE, ion exchange chromatography, and UV/vis.
• Experience with oversight of external contract development and manufacturing (CDMO)
• Ability to problem solve emerging issues related to drug substance development.
• A strong understanding of biologics and small molecule manufacturing, analytical development, quality control, quality assurance, and regulatory functions.
• 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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Role Summary:

The Associate Director, Oligonucleotide Development will lead the chemical synthesis strategy for PMO and ASO payload molecules, managing execution both internally and across global CDMOs. This role spans the full development lifecycle - from preclinical process and analytical development through GMP manufacture for IND-enabling studies.  The role will ensure the delivery of robust, scalable, and cost-effective manufacturing processes, serve as the primary technical lead for external CDMOs, driving aggressive timelines while delivering well-characterized products optimized for our proprietary bioconjugation platform.  As a core member of multiple CMC teams, the Associate Director of Oligonucleotide Development will steer the development of preclinical assets and define CMC strategies within a matrixed environment. The role will play a critical role in global regulatory filings (IND, IMPD, etc.) by authoring and reviewing key Module 3 sections. 

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:

Technical Leadership & Strategy

• Drive Process Excellence: Lead the design, optimization, and execution of process development for PMO and ASO payload molecules, ensuring scalability for clinical and commercial supply.
• Define Analytical Strategy: Set the vision for analytical development, focusing on robust impurity control strategies, raw material specifications, and comprehensive physicochemical characterization for both payloads and conjugated drug substances.
• Innovate & Improve: Proactively identify and implement emerging technologies and "continuous improvement" initiatives to enhance product quality and manufacturing efficiency.
• Cross-Functional Liaison: Act as the primary CMC representative to internal teams, defining and defending compliant, phase-appropriate CMC strategies in a matrixed environment. Prepare technical source documents, publications, and oral presentations.
• Prepare and review relevant CMC and product related sections and documentation for global regulatory submission.
• Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports.

External Partner & Project Management

• CDMO Governance: Lead the selection, qualification, and strategic management of external CDMOs to ensure alignment with corporate goals and aggressive timelines.
• Technology Transfer: Spearhead the seamless transfer of processes and analytical assays to external partners, ensuring technical success and data integrity.
• Issue Resolution: Serve as the technical lead for resolving complex manufacturing or analytical challenges, driving timely and data-driven solutions.

Regulatory & Quality Compliance

• Regulatory Authoring: Lead the preparation and technical review of global regulatory filings (IND, IMPD, etc.), ensuring high-quality, submission-ready Module 3 content.
• GMP Oversight: Review and approve critical development and cGMP documentation, including Tech Transfer protocols, Master Batch Records (MBRs), and Campaign Summary Reports.
• Knowledge Dissemination: Oversee the creation of technical source documents, publications, and high-level presentations for internal stakeholders and external forums.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience. 
• Oligonucleotide Expertise: Proven track record in the process chemistry and development of PMO and ASO oligonucleotides, including deep technical knowledge of synthesis and purification.
• CMC Lifecycle Mastery: Extensive experience defining and implementing CMC strategies from pre-IND/concept phases through clinical cGMP manufacturing.
• External Management: Direct experience in the selection, qualification, and oversight of CDMOs, including managing technology transfers and cGMP manufacturing campaigns.
• Regulatory Authority: Expert knowledge of FDA, EMA, and ICH guidelines with a successful track record of authoring and reviewing Module 3 sections for global regulatory submissions (IND, IMPD, etc.).
• Analytical Depth: Technical proficiency in analytical development, including impurity control strategies and physicochemical characterization of payload and conjugated drug substances.
• Strategic Problem Solving: Ability to navigate shifting priorities and evolving timelines using robust analytical and risk-mitigation capabilities.
• Collaborative Influence: Exceptional interpersonal and communication skills, with a proven ability to lead and influence cross-functional teams, contractors, and third-party vendors.
• Project Leadership: Strong project management skills, with the ability to independently drive complex CMC programs to completion within aggressive timelines.

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Role Summary:

The Associate Director, Formulation and Drug Product Development will be accountable for all internal and external activities related to successful formulation development for Dyne’s bioconjugate drug products to ensure favorable manufacturability, product quality, and long-term stability. This role will partner closely with colleagues in Research, Pharmaceutical Quality, and Manufacturing to define Dyne’s strategy for bringing best-in-class medicines to patients in need, including high-concentration formulations for subcutaneous administration and lyophilized drug products to ensure seamless supply of all drug products for clinical trials.

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:

• Act as the subject matter expert for drug product development within the Technical Development group, including formulation development, selection of container closure systems, and sterile fill finish clinical manufacturing.
• Act as main point of contact for CDMO(s) for external formulation development activities, and liaise with the Research group to define, streamline and execute early-stage formulation development efforts.
• Build and enhance internal capabilities for formulation development in the laboratory.
• Responsible for development, tech transfer, and scale-up of drug product processes, and cGMP manufacturing of clinical grade drug product (Phase 1-3).
• Key contributor to drug product sections of early-stage clinical filings (INDs/IMPDs/Health Canada).
• Collaborate with Technical Development, Manufacturing, Quality Control, Quality Assurance, and Regulatory Affairs to ensure continuity of drug supply for early clinical evaluation.
• Responsible for driving execution of the formulation development plan at CDMO (PO through delivery).
• Champion a strong winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration.

Education and Skills Requirements:

• PhD or equivalent experience in a scientific discipline and a minimum of 8+ years related experience. 
• Proven experience in clinical drug product formulation development including liquid fill finish, lyophilization, subcutaneous formulations, and other injectables.
• Expertise in sterile fill-finish early clinical manufacturing as well as understanding of analytical techniques that support manufacturing activities.
• Demonstrated understanding of the principles and applications associated with external manufacturing operations from development to clinical manufacturing.
• Strong experience and knowledge of cGMP manufacturing requirements.
• Strategic thinker with a sense of urgency to deliver quality results on time and in a highly ethical and professional manner.
• Experience managing complex schedules and priorities in a dynamic biotech environment.
• Ability to work, influence, and gain consensus across multiple functions (Technical Operations, Quality and Regulatory Affairs).
• Collaborative work style to be part of a team to identify process gaps and constructively develop solutions.
• Excellent interpersonal, verbal, and written communication skills with the ability to establish strong cross-functional relationships.
• Resilient and able to work in a demanding, fast-paced environment and capable of supporting multiple programs and vendors.

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Role Summary:

The Principal Engineer, Technical Development serves as a technical engineering lead and driver for strategy, conception, optimization, and implementation of innovative manufacturing technologies within the Technical Development organization. This leader blends deep engineering expertise with cross-functional influence to implement innovative manufacturing systems for bioprocess and bioconjugation at clinical and commercial scales and accelerates time to market. The role is ideal for someone who thrives at the intersection of innovation, operations, and process development strategy.

This is a full-time position based in Waltham, MA with no option for remote work.

Primary Responsibilities:

Technical Leadership

• Design, optimize and implement engineering for manufacturing processes for new and existing products under current Good Manufacturing Practices (cGMP)
• Lead engineering technology selection, process modeling, equipment specification, and system integration and provide guidance and oversight of outsourced activities at CDMOs.
• Develop and validate process control strategies, including PAT, automation, and real time monitoring.
• Serve as the subject matter expert for engineering across manufacturing, operations, and R&D.

Strategic Impact

• Build and execute the long-term engineering roadmap for manufacturing capabilities across all relevant modalities (biologics, oligonucleotides, and bioconjugates).
• Identify opportunities to transition batch processes to innovative platforms, improving throughput and cost-of-goods, while preserving product quality.
• Partner with senior leadership to align manufacturing strategy with business goals and regulatory expectations.

Cross Functional Collaboration

• Work closely with Quality, Supply Chain, and Manufacturing Operations to ensure seamless technology transfer and scaleup.
• Guide technical teams through engineering design reviews, process risk assessments, and regulatory submissions, fostering a culture of innovation and technical excellence.

Operational Excellence

• Drive continuous improvement initiatives using Lean, Six Sigma, and advanced process analytics.
• Troubleshoot complex manufacturing challenges and implement robust, sustainable solutions.
• Ensure compliance with cGMP, safety standards, and global regulatory requirements.

Education, Experience, and Skills Requirements:

• Bachelor’s degree in chemical or similar engineering discipline with minimum of 7 years relevant experience; advanced degree MS or PhD preferred
• Proven track record designing, implementing, and scaling manufacturing systems
• Hands-on approach for operation of and troubleshooting manufacturing skids
• Development and implementation of PAT technologies
• Experience overseeing outsourced activities at CDMOs
• Expertise in process modeling, control systems, automation, and PAT.
• Experience in Biologics Downstream Purification Process Development and/or Bioconjugation Development preferred
• Familiar with the concepts of Scale-Down Model Qualification (SDMQ), Process Characterization, and defining Process Control Strategy (PCS)
• Strong understanding of current Good Manufacturing Practices (cGMP) and regulatory frameworks (FDA, EMA, ICH) relevant to continuous manufacturing of biologics.
• Attention to detail, exceptional communication skills, and the ability to influence all levels of the organization.