GenEdit is a rapidly-growing, early-stage company that is developing a proprietary and novel delivery platform with the potential to transform genetic medicine. Our interdisciplinary team works together across chemistry, payload design, formulation, and screening and preclinical groups to develop the next generation of gene therapies. GenEdit fosters an exciting and dynamic environment where we value impactful data and creative solutions to accelerate our progression from a platform technology to a pipeline of therapeutic candidates.
Summary
GenEdit is seeking a highly motivated professional with expertise in CMC and non-clinical development of nanoparticle (NP)–based mRNA therapeutics. The role will support the transition of mRNA drug candidates from discovery through IND-enabling activities, with primary responsibility for formulation development, characterization, process development, and non-clinical readiness. This position will be responsible for selection and management of CDMOs and requires strong cross-functional collaboration between Manufacturing and Analytical teams and Discovery, Non-Clinical (PK/ADME and Toxicology), Regulatory, and Quality.
Responsibilities
CMC Strategy & Leadership
• Define and execute the CMC strategy for GenEdit’s hydrophilic polymeric nanoparticle-(HNP)-based mRNA therapeutics from early development through commercialization.
• Serve as the CMC SME for mRNA drug substance, nanoparticle formulation, and drug product manufacturing.
• Lead and mentor a multidisciplinary CMC team, fostering technical excellence, accountability, and cross-functional collaboration. Represent CMC at program teams, governance committees, and executive leadership reviews.
Process & Product Development
• Oversee development, optimization, and scale-up of mRNA synthesis, purification, and formulation into HNP.
• Ensure robust control of critical quality attributes (CQAs) and critical process parameters (CPPs) for nanoparticle-based mRNA products.
• Guide formulation, fill-finish, and container closure development, including stability strategies for mRNA therapeutics.
• Drive platform approaches to enable efficient lifecycle management and pipeline expansion.
Manufacturing & External Partnerships
• Provide strategic oversight of internal and external manufacturing activities, including CDMO selection, tech transfer, and ongoing operational performance.
• Lead manufacturing readiness for clinical and commercial supply, including capacity planning and risk mitigation.
• Ensure compliance with cGMP requirements across all manufacturing operations.
Regulatory, Compliance, and Quality
• Lead CMC contributions to global regulatory submissions (IND/CTA, BLA/MAA, and amendments), with specific expertise in nanoparticle-based mRNA products.
• Interface with regulatory authorities on CMC-related topics, including comparability, process validation, and lifecycle changes.
• Partner with Quality to establish and maintain compliant quality systems supporting mRNA and nanoparticle manufacturing.
• Drive continuous improvement initiatives to enhance product robustness, cost of goods, and supply reliability.
Qualifications
Education
• PhD in Synthetic Biology, mRNA and Nanoparticle Sciences, Pharmaceutical Sciences, Biopolymer Engineering, or a related discipline
Experience
• Minimum of 10+ years experience with 5+ years of industry experience leading CMC activities in biopharmaceutical development, with significant leadership experience at the director or senior manager level.
• Demonstrated expertise in mRNA therapeutics and nanoparticle delivery systems (e.g., lipid nanoparticles, polymeric nanoparticles).
• Proven experience supporting clinical and/or commercial regulatory submissions for complex biologics or advanced modalities.
• Strong background in process development, scale-up, and GMP manufacturing of biologics.
Skills & Competencies
• Deep technical knowledge of mRNA synthesis, nanoparticle formulation, analytical characterization, and stability.
• Experience with key analytical techniques: UV spectroscopy, gel electrophoresis, capillary electrophoresis, HPLC, qRT-PCR, MS, DLS, PALS, MALS, and TFF.,
• Strategic thinker with the ability to translate scientific innovation into executable CMC plans.
• Strong leadership, communication, and stakeholder management skills.
• Experience managing external partners and global, cross-functional teams in a fast-paced environment