Science & Research Jobs in Waltham, MA (Now Hiring) — 309 open — Page 6

Role Summary:

The Director, Biologics Development leads the strategy and execution of biologics development activities to advance Dyne’s therapeutic programs from early-stage development through clinical and commercial readiness. This role shapes development strategies, ensures alignment across cross-functional teams, and drives technical excellence in biologics development. The Director applies deep scientific and industry expertise to solve complex challenges, influence decision-making, and enable successful program delivery that supports Dyne’s mission of delivering meaningful outcomes for patients.

The role will ensure the delivery of robust, scalable, and cost-effective second-generation 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 CMC team member, the Director of Biologics 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 and requires regular onsite presence, typically four to five days per week.

Primary Responsibilities Include:

Technical Leadership & Strategy

• Drive Process Excellence: Lead the design, optimization, and execution of process development for biologics, ensuring scalability for clinical and commercial supply.
• Innovate & Improve: Proactively identify and implement emerging technologies and continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Define Dyne’s strategy for implementation of new technologies to lower cost-of-goods

Cross-Functional Liaison: 

• Act as the primary CMC representative for Technical Development to internal teams, defining and defending compliant, phase-appropriate CMC strategies in a matrixed environment. Prepare technical source documents, publications, and oral presentations
• Function as liaison with Research and Platform Innovation teams, to prepare new biologics assets for Candidate Nomination, steer Developability and Manufacturability Assessments, and ensure a seamless transition into Technical Development

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 biologics processes 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:

• Bachelor’s degree in Biology, Biochemistry, Pharmaceutical Sciences, or related discipline; advanced degree preferred
• 10+ years of biopharmaceutical industry experience with demonstrated progression in biologics development
• Experience leading teams or cross-functional initiatives in a matrixed environment
• Proven track record advancing biologics programs from early development through clinical cGMP manufacturing
• Deep expertise in protein expression, purification, and biologics process development
• Experience defining and executing CMC strategies from pre-IND through clinical development
• Strong track record managing CDMOs, including oversight and technology transfer
• Working knowledge of FDA, EMA, and ICH guidelines, with experience contributing to Module 3 regulatory filings
• Experience in analytical development, including impurity control, viral safety, and physicochemical characterization
• Demonstrated ability to lead complex programs and influence cross-functional teams and external partners
• Strong strategic thinking, problem-solving, and decision-making skills in a fast-paced environment
• Excellent communication skills, with the ability to clearly convey complex technical concepts
• Effective project management capabilities, balancing competing priorities and timelines

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