Manager, Clinical Supply Operations
Core
Manage clinical supply requirements by overseeing cGMP operations at CDMOs for finished drug products.
Role type
Manager, Clinical Supply Operations
Builds
Clinical drug supply chain and packaging/distribution services
Domain
Biotechnology / Oncology / Clinical Supply Chain
Required skills
Supplier relationship management, cGMP clinical packaging and labeling operations oversight, Virtual Management Team leadership, clinical trial design and demand analysis, inventory and batch production planning, technical review of batch records and change controls, global logistics coordination, budget monitoring and cost variance analysis, CDMO performance monitoring via KPIs, sourcing and audit qualification of new CDMOs, technology transfer and process validation support, supply risk assessment and mitigation
Preferred skills
APICS certification, experience with highly potent products, IRT/RTSM systems expertise, enterprise ERP systems familiarity, cGMP deviation investigations and corrective actions
Technologies
IRT/RTSM systems, Enterprise ERP systems
Responsibilities
Serve as primary liaison between CDMO and Immunome; Lead Virtual Management Teams to ensure deliverables stay on track; Conduct meetings with CDMOs to monitor progress on label development, production, and logistics; Partner with Supply Chain Planning to analyze inventory and plan batch production; Support technical reviews of batch records, specifications, and change requests; Work with Global Logistics to ensure on-time shipments; Collaborate with Legal on service agreements; Monitor and track spending against budget; Monitor CDMO performance through KPIs; Support sourcing, audit, and qualification of new CDMOs; Support technology transfers, process validations, and regulatory submission reviews; Support network risk assessments and supply risk mitigation measures
