Teams at CRISPR Therapeutics

Develops and scales downstream purification processes for mRNA drug substance from bench through pilot scale, then transfers them to external CDMOs for engineering and GMP campaigns. Responsibilities include chromatography, filtration, impurity clearance, scale-up modeling, mass balance, technology transfer, partner-site troubleshooting, campaign support, deviation investigations, and process improvement. Collaborates with upstream, analytical, formulation, supply chain, quality, and commercial teams.

Leads cross-functional biotechnology R&D programs from discovery through early clinical development. Develops integrated strategies, plans, timelines, milestones, and risk mitigations; drives alignment across preclinical, CMC, manufacturing, regulatory, clinical, commercial, and finance teams. Represents programs to senior management, facilitates issue resolution and decision-making, manages stakeholder and alliance communications, and improves program execution processes. Requires strong knowledge of gene editing, cell and gene therapies, biologics development, and early clinical and regulatory activities.

Develop, validate, and modify SAS programs to analyze clinical trial data; create and validate CDISC-compliant SDTM and ADaM datasets; implement edit checks and produce high-quality tables, figures, and listings; collaborate with Clinical Operations, Data Management, and Biostatisticians for timely FDA submissions.