Principal Engineer, Technical Development

Dyne Therapeutics•Waltham, MA

4h•$147,000 - $180,000•Onsite

About The Position

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. 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.

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.
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.

Nice To Haves

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)

Responsibilities

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.
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.
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.
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.