Sr. Director - mRNA Process Development

Role Summary

Senior Director of mRNA Process Development to lead internal and external efforts in advancing an mRNA-based therapeutic production platform from early phase clinical to commercialization. Provide strategic and technical leadership in mRNA manufacturing process development — including plasmid DNA production, in vitro transcription (IVT), purification, and product characterization. Manage matrix teams and partnerships across CDMOs, CROs, and internal stakeholders.

Responsibilities

• Provide technical and strategic leadership for the end-to-end development of robust, scalable, and regulatory-compliant mRNA manufacturing processes.
• Guide microbial fermentation and plasmid DNA production.
• Establish optimized and scalable IVT platforms.
• Drive purification and impurity removal strategies to ensure high product quality and reproducibility.
• Partner with Analytical Development to define CQAs and develop characterization assays.
• Provide scientific oversight, coordinate and manage technology transfer, and troubleshooting for external manufacturing partners.
• Collaborate with cross-functional teams (e.g. Research, Analytical, Drug Product, Clinical and Regulatory) to align process development with clinical and regulatory strategies.
• Lead or support regulatory submissions.
• Support due diligence efforts in business development activities. Mentor and develop a high-performing matrix technical team capable of delivering on program and organizational goals.
• Foster a collaborative environment that promotes innovation, scientific excellence, and continuous improvement.

Qualifications

• Ph.D. in Chemical Engineering, Biotechnology, Biochemistry, or a related field with 8-10 years of experience in process development for mRNA-based therapeutics or biologics in the biopharmaceutical industry.
• Proven track record and hands-on experience in process development for plasmid DNA production, IVT, purification, and characterization of nucleic acid products.
• Deep knowledge of mRNA CQAs, impurity profiles and strategies for removal.
• Experience with efficient experiment designs for process optimization, scale up, tech transfer and manufacturing support.
• Proven track record of defining robust control strategy for clinical and commercial manufacturing, successful process validation and regulatory submission (IND, IMPD, BLA, MAA etc.).
• Strong leadership and people management skills; experience overseeing both internal teams and external CDMO/CRO collaborations.
• Excellent communication, ability to effectively lead a cross-functional team, prioritize activities to meet program goals and schedule.

Skills

• Deep purification and engineering background
• Familiarity with LNP formulation and drug product considerations
• Strong regulatory interaction experience (FDA, EMA, other health authorities)