Syncromune

Lead the implementation and administration of the Pharmaceutical Quality System (PQS) and electronic Quality Management System (eQMS) to support growth from startup to commercial operations. Manage internal audits, regulatory inspections, and ensure alignment between internal quality requirements and external CDMO activities.

Provide strategic and operational leadership for analytical development and quality control activities supporting late-phase drug substance and product development. Oversee method development, validation, and lifecycle management while managing internal teams and external partners like CROs and CMOs.

Oversee the analytical strategy for drug substance and drug product development from clinical phases through commercialization. Lead method development, validation, and transfer while managing external CDMO and CTL resources.

Oversee the installation, maintenance, and functioning of combination product medical devices at oncology clinical trial sites. Provide technical guidance and training to site staff while troubleshooting equipment issues to ensure seamless trial operations.