Director, Biologics Drug Product Development
Core
Spearhead technical development and optimization of biologics drug products, guiding them from pre-clinical stages through commercial manufacturing.
Role type
Director, Biologics Drug Product Development
Builds
Scalable and cost-effective commercial manufacturing processes for biologics
Domain
Biopharmaceuticals / Biologics
Required skills
Biologics drug product development, Liquid and lyophilized formulation development, Subcutaneous product development, Global regulatory requirements for injectables, Aseptic process scale-up, CDMO partner management, Process development and stability modeling, Team leadership, Cross-functional collaboration
Preferred skills
Strategic vision, Predictive modeling for molecule developability, Experience with combination drug-device products
Technologies
None explicitly listed
Responsibilities
Lead design and development of parenteral dosage formulations from pre-clinical to commercial launch, Partner with tech transfer teams to progress fill-finish development, Provide leadership to scientists managing workload and fostering innovation, Oversee staff performance and career development, Drive innovation in technologies for challenging subcutaneous and combination drug-device products, Interact with drug substance, analytical development, and regulatory CMC activities
Seniority
Director, Management level
