Job for Jr. Research Scientist / Research Scientist at Abbott India Limited
Post : Jr. Research Scientist / Research Scientist
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Purpose of Job: Deliver formulations in defined timeframe to meet product delivery goals for I&D Development of different formulations either as generic or differentiated generics. To demonstrate successful stability and scale up at manufacturing site.
Key Accountabilities, Responsibilities and Deliverables:
• Development of formulation using scientific rationale in use of additives to create a reproducible prototype formulation.
• Ensure Proper documentation of every trial in the log note books and then using the information for creation of the Product Development Report for use in dossier for filing.
• Use of QbD wherever required for Product and process optimization.
• Ensure proper upkeep, maintenance and calibration of the equipment.
• Ensure scale up of the developed formulation works at engineering batch level.
Key Deliverables:
• Literature/Patent search to create drug profile
• Prototype development with rationale use of additives
• Preformulation study as may be required for formulation development
• Conduct 6 months accelerated stability studies to ensure stable formulation
• Scale up studies at 1/10th scale or engineering batch
• Technology transfer and manufacturing of Bio/Clinical batch
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Functional / Technical:
• Formulation and Product Development
• Schedule and follow all the steps to deliver the drug as per QTPP
• Select the suitable polymers / excipients based on either properties or scientific rationale
• Evaluation of CQA of drug / excipients and estimate its implications for product development
• Designs the process which is reproducible and scalable with higher yield, cost effective, and environment friendly
• Design of Experiments
• Executes the experiments as per DOE to optimize product and process
• Pharmaceutical Development Report (PDR)
• Prepares PDR as per Common Technical Document (CTD) module 3 requirements
• Complies with regulatory requirements as defined in QTPP
• Project Management
• Is able to plan and prioritize multiple project deadlines to meet product delivery goals
Additional Information:
Location: Mumbai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: R&D
Job ID: 30879258
End Date: 12th April, 2018
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