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Job Position: Scientist -Formulation: 3 to 10 years in R&D experience,
Formulation development of Parenteral dosage forms like solutions, Lyophilized drug products and particularly complex dosage form injectable suspensions.
• Good exposure on handling of injectable suspensions.
• Good Exposure in scale up/exhibit batches of injectable suspensions/Lyophilized/solution drug products.
• Assist in the investigation of complaints/OOS/OOT’s raised for exhibit/commercial batches.
• Literature survey, formulation trials for development of drug products.
• Completion of project as per the timelines and trouble shoot the scientific aspects of the projects on need basis.
• Sourcing and materials qualification done for new raw material and packaging materials for new parenteral products.
• Identify and optimize suitable process parameters and components for manufacturing the Products.
• Review study protocols & reports.
• Closely monitored project’s progress/status.
• Reviewed filter validation protocols & reports.
• Prepared PDR & handled regulatory queries.
• Prepare/review Technology transfer documents (MFR, Stability protocol & other documents) for Pilot/Exhibit/commercial batches.
• Co-ordinate with various departments like vendor, purchase, IPR, production, QA-QC and regulatory for smooth development and execution of drug product.
• Involve in the preparation and revision of SOP’s.
• Prepare stability protocols, conducted stability studies and data interpretation as per ICH guidelines.
• Maintain and improve standards of Good Laboratory practice.
Location: Chennai only.
Salary is not the constraint for the right candidates.
|Experience||3 - 9 Years|
|Salary||3 Lac To 9 Lac P.A.|
|Industry||Pharma / R&D / Biotech|
|Qualification||Post Graduate Diploma, Ph.D/Doctorate|
|Key Skills||Research Scientist Pharmacovigilance Formulation Development Drug Regulatory Affairs Pharma HPLC Formulation Scientist|
|Contact Person||D. Mukherjee|
|Address||Flat-103/C, First Floor, Thakurbari Apt, Block-B, 8,Hem Pal Lane, P.O. Belur Math-711202|