An experienced Pharmaceutical Scientist with about 9+ years of research experience of Pharmaceutical MNCs with a track record of success. Developed many innovative but cost-effective, stable and quality 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.
Since October 2012
- Heading R&D team for 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.
February 2011 --- October 2012
- To conduct Research and Development of new products includes Generic Pharmaceutical Products Over-The-Counter (OTC) products, Nutritional Health Supplements.
- Third party manufacturing QA related activity like Change control, Deviation management, Product Complaint management, batch release, OOS/OOT, CAPA, Document review/control, overall quality system management.
- API resourcing to obtain API of the pure quality.
- To undertake laboratory trials for Solid and Liquid Pharmaceutical formulation and complete Technology Transfer at Production Level.
- To participate “Exhibit batches” and responsible for successful completion of initial production batches along with stability study as per ICH guidelines.
- To assist in clinical study protocol preparation and monitor the study for assigned projects.
- To prepare Product Development Report (PDR) according to ICH Q8.
BASF Pharma Application Lab
January 2009 --- February 2011
- Worked as a key formulator for solid, liquid and semi-solid dosage forms
- Handled NCE (New Chemical Entity) and New Excipient Entity (NEE) for global projects.
- Actively involved in developing various modified release and immediate release film coatings for tablets and pellets.
- Worked on NDDS (Novel Drug Delivery System) formulation like Hot Melt Extrusion, MUPS
- Provided technical solution for global projects such as dissolution matching, patent infringement, SR,DR coatings.
- Technical support for scale-up of developmental products from lab to production scale.
- Actively involved in formulation development of solid dosage formulation using different pharmaceutical excipients in cost effective ways
January 2007 --- January 2009
- Handled Para III, Para IV
- Successfully done first two ANDA of company from Initial development, Successful BE Study, exhibit batch and successful transfer to Production Unit.
- To write investigational reports, project summaries, project updates, as required.
- Develops and writes laboratory SOP’s, test methods and operating instructions for equipment and processes.
- To reviews scientific literature, attends appropriate training, seminars and presentations to maintain expertise in formulation development, manufacturing equipment and processes, raw materials, pharmaceutical technologies and related areas.
January 2006 --- January 2007
CuriosityOrientationEfficiencyTrustCollaborationService orientedApproachabilityProblem solvingAdaptabilityIndependenceInterest in knowledgeIndividualityInterest in knowledgeOrientationTrustCuriosityService orientedIndividualityProblem solvingIndependenceSelf-confidenceEfficiencyAnalytical thinkingCoordinationAttention to detailStrategic thinkingProactivityOrganizationCreative thinkingSelf-disciplineInnovative thinkingSelf-disciplineInnovative thinkingCollaborationCoordinationApproachabilityStrategic thinkingAdaptabilityOrganizationSelf-confidenceAnalytical thinking
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
Skills and Expertise
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
PG Diploma in Regulatory Affairs in Regulatory Affairs from SICR in 2012
Doctor of Philosophy (PhD) in Pharmaceutical Sciences from KU AP India in 0
Masters of Pharmacy in Pharmaceutical Sciences from Rajiv Gandhi University of Health Sciences in 0
Training and Certification
Patents Art Search in 2015 Certification
Cost saving in manufacturing in 2014 Certification
Expert has 1 publications (Will be avalible with full profile)