Miltenyi Biotec Benefits Overview

Leads regulatory CMC strategy and execution for cell and gene therapy programs across global regions. Oversees CMC content for INDs, CTAs, BLAs, and MAAs; supports health authority interactions, process changes, comparability, validation, change control, risk mitigation, and post-approval lifecycle management. Partners with development, manufacturing, regulatory operations, and external consultants to deliver submission-ready documentation and support clinical development, marketing authorization, and commercial launch activities.

Leads global CMC Regulatory Affairs strategy for a Cell and Gene Therapy portfolio across development, registration, commercialization, and lifecycle management. Oversees regulatory submissions, manufacturing change assessments, process and analytical strategies, health authority interactions, risk mitigation, and compliance with global requirements. Manages and mentors CMC Regulatory Affairs leaders while collaborating with process development, manufacturing, quality, supply chain, and clinical development teams.

Develop and optimize spatial biology, multiomics sequencing, and in situ sequencing workflows for commercial platforms. Design and analyze experiments, prepare samples and libraries, run sequencing assays, validate performance, develop reagent panels, troubleshoot technical issues, and support technology transfer and commercialization. Collaborate with scientists, engineers, and product teams; document procedures, maintain laboratory operations, present findings, and mentor junior staff while following safety and regulatory requirements.