The role provides strategic and technical leadership across Technical Operations, Quality, Regulatory CMC, and external partners to support development, technical transfers, process validation, regulatory submissions, clinical bulk supply readiness, commercial preparedness, and lifecycle management. Drug Product, Medical Device, and Combination Product Development within CMC Activities:
- Lead analytical strategy for drug products, devices, and combination products, including methods, characterization, stability, extractables and leachables, and peptide-specific support.