Assistant Manager/ Deputy Manager

DEVICE DEVELOPMENT SCIENTIST

• Robust Packaging Design for Drug Device Combination products (Complex Generics Injectable Products) for regulated markets.
• Literature research & identifying the right devices for Drug Device Combination Products.
• Innovator samples analysis / characterization of packaging components.
• Define strategy for Drug Device Combination Products (DDCP) & align all functions of organization.
• Coordinate with Manufacturer & develop and execute end to end packaging solutions across all formats of devices including Pen Injectors, Auto-Injector, Syringes and etc.
• Ensuring compliance of device regulations as per 21 CFR 820, ISO 11608, 14971, FMEAs, Risk Management/control.
• Develop, validate & Implement various packaging analytical laboratory testing equipments and method developments.
• Responsible for conducting Device Functionality Tests & generating the documents for regulatory submission of combination products.
• Internal procedures (SOP/STPs & etc.) should aligned as per current standards for Drug Device Combination Products.
• Responsible for generating DHF documents for Device products.
• Identify & responsible for conducting DVT studies at external labs for Device products.
• Responsible for identifying the external labs for Human Factor Studies.
• Responsible to provide scientific justification for packaging queries/deficiencies for regulatory authorities.
• Handling of troubleshooting for Device Developmental activities related to combination products.
• Responsible for Exhibit & other trial batches as per machine and material requirement.
• Preparation of Spec’s, STP’s, Trade Dress, BOM’s & necessary documents for device products.
• Coordination with all internal stack holders & align the strategy of Device products.
• Supporting to regulatory filings of Global markets for Device products.
• Technical support to all internal CFT’s for Device products.
• Coordination with vendors, design & develop the Device assembling m/c’s / procedures.
• Coordination with vendors, design & develop the Device functional test equipment’s.
• Timely completion of all internal activities related to Device & meet the project target time lines.