Lead laboratory activities and characterization studies
Evaluate and select raw materials for inhalation products
Independently designs and conducts experiments including preformulation, formulation and process development studies for pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI) products
Job Summary
Independently designs and conducts experiments including preformulation, formulation and process development studies for pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI) products.
Leads and supervises standard and advanced laboratory activities including characterization studies for pMDI and DPI products.
Writes protocols, methods, reports, standard operation procedures, batch manufacturing records, and regulatory submission documents to support submission and product approval when required.
Matching Summary
Independently designs and conducts experiments including preformulation, formulation and process development studies for pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI) products.
Skills & Requirements
Must-have
Design and conduct experiments for pMDIs and DPIs
Lead laboratory activities and characterization studies
Evaluate and select raw materials for inhalation products
Adhere to cGMP, EH&S guidelines
Lead investigations and manage quality events
Nice-to-have
Develop new formulation technologies
Act as subject matter expert
Communicate effectively across global sites
Establish and maintain effective relationships
Key Requirements
PhD in Pharmaceutical Sciences/Technology/Chemistry/Chemical Engineering with 8+ years experience
MS in related field with 12+ years experience
In-depth knowledge of pMDI and DPI formulation/process development
Knowledge of aerosol and material characterization methodologies
Understanding of regulatory requirements for OINDPs