Teams at AbCellera

Leads drug product Manufacturing Sciences and Technology strategy for biologics, overseeing external fill-finish manufacturing, technology transfers, process performance, batch documentation, validation, sampling plans, equipment qualification, investigations, CAPA, vendor management, and regulatory filings. Serves as the senior technical authority for CDMOs and drives process improvements, risk management, and cross-functional alignment across development, procurement, quality, and regulatory teams.

Develops pharmaceutical combination products, including prefilled syringes and autoinjectors, through design controls, risk management, verification and validation, human factors, packaging and distribution studies, scale-up, and regulatory submissions. The role oversees external device suppliers and CDMOs, supports quality systems and supplier controls, and collaborates with Quality, Regulatory, Formulation, and Drug Product teams to advance products toward clinical and commercial readiness.

Leads device development strategy for drug-device combination products, including prefilled syringes and autoinjectors, from clinical development through commercialization. Oversees design controls, risk management, human factors, regulatory documentation, quality systems, supplier governance, technical transfers, packaging, and distribution strategies. Manages engineers and external partners while coordinating with Clinical, Quality, Regulatory, Manufacturing, Formulation, Drug Product, Commercial, and Supply Chain teams. Requires extensive combination-product engineering experience and expertise in applicable FDA regulations and international standards.