Manager, Product Development
Core
Leading technology transfer of clinical and commercial radiopharmaceutical products from sponsors to a network of cGMP manufacturing facilities.
Role type
Manager, Product Development (Radiopharmaceuticals)
Builds
Radiopharmaceutical products for innovator partners
Domain
Pharmaceutical manufacturing / Radiopharmaceuticals / cGMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, technology transfer, process qualification, method validation, analytical instrumentation operation (HPLC/GC/TLC), regulatory guidelines (USP/EP/ISO/ICH/CFR), equipment selection, governance documentation, facility setup, process adaptation
Preferred skills
Radiopharmaceutical manufacturing experience, product research and development background, contract manufacturing experience, collaboration with business development
Technologies
HPLC, GC, TLC, chromatography data systems, production and laboratory equipment
Responsibilities
Plan and deploy resources for technology transfer and qualification of contracted products; Administer and report on manufacturing and testing activities for process qualification; Lead investigations and document deviations during technology transfer; Train facility personnel on new manufacturing and testing procedures; Provide technical support as a legacy owner of sponsor products; Partner with business development on CDMO opportunities
Seniority
Manager, hands-on leadership
