Rakeshkumar Dhanwani

•Spearheading a dynamic team of Development and Technology Transfer Scientists, technicians, Analysts and DQA •Facilitating Product Designing, Development & manufacturing of Registration/Exhibit/Commercial launch batches •Assisting product ideation and selection activities with technical due diligence on feasibility within IP constraints •Defining New Projects proposals /Costing /Pre-requisites/Deliverables/Plans for each product in consultation with BD, SCM, IP, RA and Clients •Support laying down various legal and commercial agreements with Partners such as confidentiality disclosure agreement, master service agreement, pricing agreements, cost change orders •R&D Set up, Procurement of Equipments, their qualifications, Implementation of quality systems & SOP’s in Departments •Supportive Application for licenses (Import License/Test License/NOC/Mfg) •Lay down milestone wise timelines for the allocated programs during the lifecycle of a project •Leading teams for product development, risk evaluation & mitigation strategies, approval of submission batch documents •Procurement of RM, PM, RLD, Toolings, Columns, Impurities, Reference standards and change parts etc. •Reviewing Development strategies, Monitoring of Key milestones, developmental trials and Evaluation of Analytical data •Monitor budgetary spends with the help of finance team •Monitoring Formula optimization and Process Optimization trials •Monitoring Analytical method Development and Validations •Approval of scale up and tech transfer documents like MFR, BMR, Specifications, SSP, HSP •Approval of Bio study protocols, Review of Pilot and Pivotal Bio studies •Trouble shooting activities for improving quality/cost/productivity •Resources Management; Project Management; Time Management and Cost Management •Support to Plant QA/Production team during MOH and Client Audits •Response to the regulatory and customer queries within the timelines

•Led a dynamic and young team of 10 scientists •Preparation of Concept Note and Statement of work; and establishing Proof of Concepts for all CDMO projects •Lay down milestone wise timelines for the allocated programs in consultation with cross functional teams. Identify and communicate various decision-making milestones during the lifecycle of a product •Manage the formulation development budget and allocate resources effectively to ensure that projects are completed on time and within budget •Formulation Development of Non-Infringing formulations for Europe and Canada markets •Risk Analysis and mitigation at various stages of development •Monitor product development activities and ensure that the activities are carried out in compliance with various quality, regulatory and EHS norms. •Monitoring of developmental and Optimization trials and Evaluation of Analytical data •Review and Approval of scale up and tech transfer documents like MFR, BMR, specifications, SSP, HSP and various protocols/ reports/ justifications as required •Monitoring of process development batches (e.g., Feasibility batches, optimization batches, scale up batches, stability batches, exhibit batches, registration batches and process validation batches •Product Lifecycle Management - Support trouble shooting activities for quality improvement /cost reduction/ improvement in productivity •Supporting QA/QC for preparations of OOS/OOT & R&D investigation reports •Participate and assist RA team for regulatory query/deficiency response preparation •Support to Plant QA/Productions during Audits (EUGMP, WHO, DCGI) •Review of Quality notifications like Change Control/CAPA/Investigation and Deviations •Providing technical training to trainees and assisting juniors in developing formulation skills •Actively supported in setting up of New R&D Centre with procurement of new Equipments, their qualifications and preparations of their SOP’s

•Led a dynamic and young team of scientists •Manage the formulation development and allocate resources effectively to ensure that projects are completed on time •Formulation Development of Non-Infringing formulations for Export markets •Monitor product development activities and ensure that the activities are carried out in compliance with various quality, regulatory and EHS norms. •Monitoring of developmental and Optimization trials and Evaluation of Analytical data •Review and Approval of scale up and tech transfer documents like MFR, BMR, specifications, SSP, HSP and various protocols/ reports/ justifications as required •Monitoring of process development batches •Product Lifecycle Management - Support trouble shooting activities for quality improvement /cost reduction/ improvement in productivity •Participate and assist RA team for regulatory query/deficiency response preparation •Support to Plant QA/Productions during Audits (EUGMP, WHO, DCGI) •Providing technical training to trainees and assisting juniors in developing formulation skills •Actively supported in setting up of New R&D Centre with procurement of new Equipments, their qualifications and preparations of their SOP’s

•Formulation development of stable and bioequivalent dosage forms for generic markets •Implementation of Quality by design (QbD) principles like DoE, FMEA and Assessment of risk associated with CPP and CMA during formula and process optimization and finalization of Control Strategy within the design space •Designing and execution of Formula and Process Optimization trials •Monitoring and facilitating the progress of projects using CONCERTO Software •Finalization of batch size, area and Equipments for scale up and Exhibit batches •Planning and Procurement of RM, PM, RLD, Toolings and change parts up to Pivotal stage •Analysis and review of Bio study protocols & Reports, Invitro and Invivo data and their correlations •Coordination and supervision of manufacturing of Bio batches •Preparation and Review of documents like MFR, BMR, PVP, PVR, PDR, HSP & various protocols/ reports/ justifications/ updates at every stage of Product Development •Review and approval of Developmental reports and data for dossier compilation •SAP modules related to procurement of RM & PM, BOM & Recipe, Quality notifications like Change Control and Incidents •Support to regulatory queries & deficiencies •Work closely with cross functional teams like ADL/RA/DQA/IPM/Packaging/COE-Bio/CPPK/SCM •Technically contributed in the installation, qualification and training of tri-layered tablet compression machine •Resolved several machine related problems during scale up and exhibit batches

•Formulation development of stable and bioequivalent dosage forms for generic markets •Implementation of Quality by design (QbD) principles like DoE, FMEA and Assessment of risk associated with CPP and CMA during formula and process optimization and finalization of Control Strategy within the design space •Designing and execution of Formula and Process Optimization trials •Preparation of documents like MFR, BMR, PVP, PVR, PDR, HSP & various protocols/ reports/ justifications/ updates at every stage of Product Development •Support to regulatory queries & deficiencies •Work closely with cross functional teams like ADL/RA/DQA/IPM/Packaging/COE-Bio/CPPK/SCM •Technically contributed in the installation, qualification and training of tri-layered tablet compression machine •Resolved several machine related problems during scale up and exhibit batches

•Literature search, Pre-formulation studies, Innovator Characterization, Selection of excipients and process •Formulation development of stable and bioequivalent dosage forms for US market •Planning and execution of R&D trials, Optimization, Scale-up and Exhibit batches •Stability studies in different packing systems as per ICH guidelines, Stability data compilation and review •Documentation related to application for licenses (Import, BENOC, Test and Mfg. License) •Preparation and Review of master documents like MFR, BMR, PVP, PVR, PDR •Preparation and Review of Strategy Development Notes, Presentations and Tech reviews •Co-ordination with ADL, IPM, DRA, DQA, QC, SCM, QA, Packing and Marketing teams

•Literature search, Pre-formulation studies, Innovator Characterization, Selection of excipients •Formulation development of stable topical dosage forms •Preparation of strategies for Formulation Development •Planning and execution of R&D trials, Optimization and Scale-up batches •Literature search, Pre-formulation studies, Innovator Characterization, Selection of excipients •Formulation development of stable topical dosage forms •Preparation of strategies for Formulation Development •Planning and execution of R&D trials, Optimization and Scale-up batches •Stability studies in different packing systems as per ICH guidelines •Application for licenses (Test License and Mfg. License) and preparation of documents like MFR & BMR

Overall responsibility of managing Medical Store Dispensing prescribed medicines and selling over-the-counter (OTC) drugs Inventory Management: Receiving, storing, tracking, and managing stock efficiently