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An experienced Pharmaceutical Scientist with about 12+ years of research experience of Pharmaceutical MNCs with a track record of success. Developed many innovative but cost-effective, stable and quality CMC formulations in niche therapeutic segments.My strengths are in developing intellectual property with patent non-infringing processes development, Novel Drug Delivery Systems and applying new technology to improve the existing formulations. I have a proven track record of developing ANDAs (Generic Formulations) for highly regulated global markets. Formulation Development Expertise: • Experience on Paragraph- 4 filing of formulations and project managements. • Development of ANDAs, for highly regulated markets for all forms of Oral solid Dosage formulations. • Taste masking, Bio-enhancement and Stability improvement of pharmaceutical formulations. • Preparations and Review of Product Development Reports, Validation Protocols, Bio-Study protocols and other technical reports. • Planning and monitoring Bio-availability and Bio-Equivalnce studies and coordinating for protocol development and execution of studies. • Identifying and liaisoning with CRO/CMO for effective project management. • Setting-up new formulation R&D centre (CRO) and design of laboratories, equipment requirements and budgetary requirements etc. Specialties - Setting-up formulation R&D. - Managing multidisciplinary team of scientists. - Complete Project management-from conceptualization through product development, regulatory filling to commercialization. - Patent Drafting. - Validation Protocols, Bio-study protocols and other technical reports. - Identifying CRO/CMO. - Coordinating with Drug authorities.


Current Experience

  • Head R&D

    Since October 2012
    Change Control
    • Heading R&D team for CMC formulation development of new innovative cost effective products for Solid, Liquid, Semi-Solid and Injectable dosage forms for markets such as USA/ANDA, Europe, Malaysia, Hong Kong, China, and other ASEAN Countries markets.
    • Outsourcing of Products consisting of Finished Products, Semi-finish Products consisting of Resourcing, Drafting and negotiating of Confidential Agreement/Contracts which includes Raw Material and Finish Good Transfer, Service/Consultancy Agreement, Work Purchase Order, Cost Analysis and Plant Audit with support from Legal Department, whereever applicable.
    • Third party manufacturing QA related activity like Change control, Deviation management, Product Complaint management, batch release, OOS/OOT, CAPA, Document review/control, over all quality system management.
    • Responsible for preparation of Information Requisition and Project Proposal Request as well as the proposal evaluation process, Price negotiating structures and attending site visits to existing and new partners.
    • Managing and coordinating communication between internal functions and external partners.
    • Gather information for new potential service providers and keeping in mind overview as one of the company’s growth strategy.
    • Target and KPI Setting up for optimization of relationship with partner’s in order to focus on delivery within agreed timeline to avoid government penalty and delay in supply.
    • Working to continuously improve Partnership Management practices
    • Clinical and Bio-Equivalence Study of Developed formulations.
    • Total Quality Managing of current ongoing products by monitoring raw materials, process flow, deviation, change control review, planned/unplanned deviation report review
    • Act as Internal Quality auditor.
    • Managing Stability Study cell for Current Products and new Products.
    • Identification and Risk Assessment with tool of CMC, CPP, CQA, CMA from Formulation Development to Product commercialization and mitigate the same to achieve the Quality Targeted Product Profile (QTPP).
    • Organization’s development plan and strategy preparation by considering Regulatory, Quality and Marketing by effective utilization and execution of their respective functional goals.
    • Support to daily operations of Production Unit for effective run of existing product.
    • Responsible for preparation of Department Annual plan of Action for Product Pipeline for upcoming years and Departmental budget plan along with Costing.
    • Responsible for support on Existing Marketed Product in case of Regulatory or Production related problem and renovation of registration license and cost reduction approach using alternate formulation strategies such as different sources of API and equivalent grades of Excipients.
    • D last year for Thesis submission for Project Compilation and study conclusion.

Past Experience

  • Team Leader

    February 2011 --- October 2012
    Change Control

  • BASF Pharma Application Lab

    January 2009 --- February 2011
    Drug Delivery

  • Reseach Scientist

    January 2007 --- January 2009

  • Research Trainee

    January 2006 --- January 2007


Self Assessment :
CuriosityOrientationEfficiencyTrustCollaborationService orientedApproachabilityProblem solvingAdaptabilityIndependenceInterest in knowledgeIndividualityInterest in knowledgeOrientationTrustCuriosityService orientedIndividualityProblem solvingIndependenceSelf-confidenceEfficiencyAnalytical thinkingCoordinationAttention to detailStrategic thinkingProactivityOrganizationCreative thinkingSelf-disciplineInnovative thinkingSelf-disciplineInnovative thinkingCollaborationCoordinationApproachabilityStrategic thinkingAdaptabilityOrganizationSelf-confidenceAnalytical thinking


Self Assessment :
Microsoft OfficeMicrosoft ExcelMicroscopySOPStrategic PlanningClinical Study DesignRegulatory submissionsQualificationQuality Assurance (QA)Search literature on clinical trialsSupervising CRAsVerificationWriting Study Procedures and SOPsRegistration of the productRegulatory RequirementsoncologyPhases of clinical development (phase I to IV)Pilot scale batchesValidationData Analysis Lab scale batchesFormulationCMC Understanding of regulatory guidelinesTeam LeadershipRegulatory affairsR&DProject ManagementProblem-solving methods and troubleshootingpatentClinical trial managementContract negotiationDrug development processDrug regulatory authoritiesGMPGood Laboratory Practice (GLP)Good Manufacturing Practice (GMP)HPLCPharmaceutical IndustryClinical DevelopmentInterpret clinical trial resultsClinical researchPre-clinical researchPrinciples and ethics of clinical researchManaging Clinical Trial SuppliesClinical trial audits and inspectionsTechnical reportsClinical study reportsProcess improvementEnglishIn VitroIn VivoLaboratory study designPowerPointProduct designCAPABioavailabilityNew Drug Application (NDA)Clinical trial budgetingexhibitClinical monitoring Medical devices R&D Scientific writingProduct launchProtocolClinical trial designClinical trialsEarly development stage21 CFR Part 11Analytical methodsFormulationsDrug DevelopmentApplicationsAseptic ProcessingBiological Drug DevelopmentCancer ResearchChemistry, Manufacturing, and Controls (CMC)CMCCROCross-functional team leadershipCurrent Good Manufacturing Practice (CGMP)Drug DeliveryGood Clinical Practice (GCP)grant writing and designICH guidelinesInnovation ManagementManufacturingOperations ManagementOutsourcingPatentsPharmaceutical DevelopmentPharmaceutical managementPharmaceutical ManufacturingPharmaceutical ResearchPharmaceuticalsPhase IIIPhase IIPhase IPhase IVResearchSterile drug productsTechnological InnovationTechnical SupportTechnology transferTechnology Development
LinkedIn Assessment :
Patent DraftingFormulation developmentTechnology transferANDARegulatory affairsPharma Project ManagementAPI resourceingValidationFormulationInformaticsPatentsPharmaceuticsPharmaceutical IndustryProduct developmentCROGeneric ProgrammingRPharmacokinetics

Skills and Expertise

Self Assessment :
Formulation developmentpatent draftingproduct development Technology researchtechnologyGenerate regulatory submissions ANDARegulatory submissions Create SOPs Develop protocols Guide students Lab scale batches Search literature on clinical trialsArchive documentationAssess site feasibilityAttend investigator meetingbudgeting of R&D activitiesBuild trial master file (TMF)Build CMC development planCalculate trial timelinesChemistry Manufacturing and Controls (CMC) activitiesCollaborate with project teamCoordinate CMC-activitiesCreate SOPsData validationDevelop ICH/GCP compliant processesDevelop study budgetDevelop study timelinesDirect co-workersFollow-up of internal auditsFollow-up of external auditsForecasting of drug productManage contractors Manage trial master file (TMF)Manufacture of GMP batchesPilot scale batchesPrepare CMC source documents Regulatory documentationResearch at universitiesSolve problemsTrain on site staff


  • Doctor of Philosophy (PhD) in Pharmaceutical Sciences from KU AP India in 2019
  • PG Diploma in Regulatory Affairs in Regulatory Affairs from SICR in 2012
  • Masters of Pharmacy in Pharmaceutical Sciences from Rajiv Gandhi University of Health Sciences in 2007

Training and Certification

  • Patents Art Search in 2015 Certification
  • Cost saving in manufacturing in 2014 Certification


BrightOwl Assessment:
Self Assessment:
Full Proficiency
Full Proficiency
Elementary Proficiency

Work Preferences

  • Notice Period:
    12 weeks
  • Work From Home:
  • Work Regime:
    Permanent position
  • International:


    Expert has 1 publications (Will be avalible with full profile)

Area / Region



Driving License
  • Yes

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