Research Scientist

Pupose: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.

Key Deliverables:

• Literature/Patent search to create drug profile
• Prototype development with rationale use of excipients
• Preformulation 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

Job Title: Jr Research Scientist Formulation
Job Function: Innovation & Development Location: Mumbai (Andheri MIDC) Reporting to:Sr Group Leader Formulation Critical Success Factors: Functional/ Technical: Functional / Technical: 1. Formulation and Product Development a. Schedule and follow all the steps to deliver the drug as per QTPP b. Select the suitable polymers / excipients based on either properties or scientific rationale c. Evaluation of CQA of drug / excipients and estimate its implications for product development d. Designs the process which is reproducible and scalable with higher yield, cost effective, and environment friendly 2. Design of Experiments a. Executes the experiments as per DOE to optimize product and process 3. Pharmaceutical Development Report (PDR) a. Prepares PDR as per Common Technical Document (CTD) module 3 requirements b. Complies with regulatory requirements as defined in QTPP 4. Project Management a. Is able to plan and prioritize multiple project deadlines to meet product delivery goals Education & experience:

• M. Pharm/Ph. D.
• 5 to 7 yrs