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.
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.
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills.
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.
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.
Top Skills
Dyne Therapeutics Waltham, Massachusetts, USA Office
1560 Trapelo Rd, Waltham, MA, United States, 02451
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