Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, iversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post : Research Scientist Formulation
Job Description
Purpose:
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.
Job Responsibilities
• Development of formulation using scientific rationale in use of excipients 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.
• Development of the patent non-infringing strategy for product development.
• Preparation of regulatory documents for PK study and marketing approval from DCG (I).
• Preparation of Pharmaceutical Development report for Quality module of CTD.
Key Deliverables :
• Literature/Patent search to create drug profile
• Prototype development with rationale use of excipients
• Pre-formulation study as may be required for formulation development
• Conduct 6 months accelerated stability studies to ensure stable formulation
• Proof of concept studies to demonstrate BE or comparative PK as the case may be
• Scale up studies at 1/10th scale or engineering batch
• Technology transfer and manufacturing of Bio/Clinical batch
Critical Success Factors:
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
• Plan and executes the trial to identify Critical Process Parameters (CPP) and design the control strategy
• Overcomes the limitations / problems and effectively resolves the same
• Design of Experiments
• Plans and executes the experiments as per DOE to optimize product and process
• Applies basic principles of experimentation
• 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
Additional Information
Qualification : M.Pharm / Ph.D
Experience : 7 - 10 yrs
Location : Mumbai, Maharashtra
Industry Type : Pharma
Functional Area : Innovation & Development
End Date : 10th November, 2019
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