Job description

JOB DESCRIPTION:

Job Title : Research Scientist Formulation

Job Function : Innovation & Development

Location : Mumbai

Reporting to : Group Leader Formulation

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

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

Is able to plan and prioritize multiple project deadlines to meet product delivery goals

Education & experience:

• M. Pharm/Ph. D.
• 7 - 10 yrs

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