Teams at Amylyx

Provide CMC quality oversight for sterile and finished drug product manufacturing, packaging, labeling, distribution and related quality systems. Review and approve validation, batch, QC, stability, change control, CAPA, and regulatory submission (NDA CMC) documents. Support inspections and act as QA SME with internal teams and external contract manufacturers to ensure GMP/GDP compliance.

Lead enterprise commercial training and readiness for customer-facing teams. Design scalable curricula across disease, product, engagement, compliance, and launch readiness; manage vendors and cross-functional partners; measure training impact; establish training infrastructure, governance, and continuous improvement to support a 2027 product launch and future growth.

Lead design and execution of a comprehensive healthcare compliance program for a clinical-stage biotech nearing commercialization. Build policies, training, auditing, investigations, third-party due diligence, transparency and FMV processes, board reporting, risk assessments, and compliance operations. Advise commercial and medical teams, drive compliance committee activities, partner on enterprise risk management, and recruit/mentor a high-performing compliance organization.