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t Abbott, Research Scientist Post. Career @ Abbott.postgraduate and Pharma candidates and Ph.D.candidates are invited for a job opening at Abbott. Intrested and Eligible candidates may apply for the post online. For details check below:Job Title: Research Scientist
Job Id: 30909733
Work Location: Mumbai
Eligibility: M. Pharm/Ph. D.
Experience: 5 to 8 years
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.
Core 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
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
Is able to plan and prioritize multiple project deadlines to meet product delivery goals
