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Research Scientist

7.00 to 10.00 Years   Mumbai City   17 Dec, 2019
Abbott Healthcare
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryRetail
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

Job Title : Research Scientist FormulationJob Function : Innovation & DevelopmentLocation : MumbaiReporting to : Group Leader FormulationPurpose:Deliver formulations in defined timeframe to meet product delivery goals for I&DDevelopment 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 DevelopmentSchedule and follow all the steps to deliver the drug as per QTPPSelect the suitable polymers / excipients based on either properties or scientific rationaleEvaluation of CQA of drug / excipients and estimate its implications for product developmentDesigns the process which is reproducible and scalable with higher yield, cost effective, and environment friendlyPlan and executes the trial to identify Critical Process Parameters (CPP) and design the control strategyOvercomes the limitations / problems and effectively resolves the sameDesign of ExperimentsPlans and executes the experiments as per DOE to optimize product and processApplies basic principles of experimentationPharmaceutical Development Report (PDR)Prepares PDR as per Common Technical Document (CTD) module 3 requirementsComplies with regulatory requirements as defined in QTPPProject ManagementIs able to plan and prioritize multiple project deadlines to meet product delivery goalsEducation & experience:
  • M. Pharm/Ph. D.
  • 7 - 10 yrs
JOB FAMILY:Product DevelopmentDIVISION:EPD Established PharmaLOCATION:India > Mumbai : Mumbai Development Center - EPDADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 15 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),

Keyskills :
researchhplc chemistryvalidation apicommon technical document continuous improvement facilitationcost effective

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