Jobs at AdvanCell

Leads CMC strategy and radiopharmaceutical process development for ²¹²Pb-based APIs and products. Oversees process characterization, scale-up, technology transfer, manufacturing readiness, GMP compliance, regulatory authoring, lifecycle management, and health authority responses. Partners with Technical Development, MSAT, Quality, Engineering, Operations, and CDMOs on investigations, change controls, facility readiness, and process optimization. Establishes specifications and control strategies while mentoring CMC staff and supporting reliable clinical and commercial supply.

Oversee clinical trial operations, budgets, CRO and vendor relationships, contracts, invoices, change orders, purchase orders, and TMF quality. Partner with Finance, Legal, CMC, and preclinical teams to ensure trials meet timelines, budgets, GCP requirements, and quality standards. Monitor vendor performance, identify operational and financial risks, support inspection readiness, and train new team members on internal processes.

Leads development, optimization, scale-up, GMP manufacturing, lifecycle management, and regulatory documentation for radiopharmaceutical precursor molecules and reference standards. Provides expertise in synthetic and process chemistry, analytical development, impurity control, CDMO management, technology transfer, quality investigations, and regulatory submissions. Mentors CMC staff and supports supply chain planning, risk mitigation, and continuous improvement.

Provides strategic and technical leadership for analytical CMC development of lead-based APIs and radiopharmaceutical products. Oversees analytical strategies, methods, validation, specifications, release and stability programs, GMP manufacturing support, regulatory submissions, CDMO activities, investigations, and continuous improvement. Partners with Process Development, MSAT, Quality, Regulatory Affairs, Engineering, and external manufacturers while mentoring Analytical Development staff.