Mahendrasingh Chavan
Manager (R&D) at Vitane Pharmaceutical Pvt. Ltd.- Claim this Profile
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English Professional working proficiency
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Hindi Native or bilingual proficiency
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Marathi Native or bilingual proficiency
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Bio
Harish Bhatt
Mahendra is smart formulator understanding the timely completion of activity.
Harish Bhatt
Mahendra is smart formulator understanding the timely completion of activity.
Harish Bhatt
Mahendra is smart formulator understanding the timely completion of activity.
Harish Bhatt
Mahendra is smart formulator understanding the timely completion of activity.
Credentials
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Six Sigma Green Belt
Board of Regents of the University System of GeorgiaJun, 2021- Nov, 2024 -
eLearning Foundations of GMP: Medicinal Products
USP PQMMay, 2021- Nov, 2024 -
eLearning: Foundations of GMP: Qualification
USP PQMMay, 2021- Nov, 2024 -
USP Excipients Workshop: Impact of Excipient Grade (Q1/Q2) on Bioequivalence of Generic Drug Products
USPApr, 2021- Nov, 2024 -
Certificate Programme In Project Management
Indian Institute of Management, Indore
Experience
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Vitane Pharmaceutical Pvt. Ltd.
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Health, Wellness & Fitness
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1 - 100 Employee
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Manager (R&D)
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May 2022 - Present
•Develop robust formulations and processes for tablet, capsule, liquids, injectables dosage forms(Generics) and neutraceuticals. •Scale-up and optimization of manufacturing process; execution of pre-exhibit and exhibit batches; scale up and technology transfer from R&D to production to meet timelines. •Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports). •Author technical documents including Product Development Report, Quality Overall Summary and other relevant documents for regulatory filing purpose. •Interaction with API manufacturers, CROs and CMOs as needed. •Work proactively with other cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs and protocols. •Create and review SOPs, as well as review appropriate documentation and test results for accuracy and completeness and compliance with SOPs/GMP requirement. •Coordinate with RA for filing ANDAs and addressing deficiencies; provide relevant documents to •Regulatory Affairs in a timely manner for ANDA filings and Supplements filing. •Review of batch records, process characterization reports, validation reports and investigation reports. •Troubleshooting in existing formulations. •Formulation Development of new trial batches •Support entire drug product development process starting with first pre-formulation studies up to the manufacturing process transfer to production and the provision of the required documentation to •Regulatory affairs to allow registration. •Preparation of Bill of Materials, Master Formula Record, Product Development Report, Stability Study Protocol. •Communicate and address problems, perform safety and literature searches under guidance from more experienced •Provide technical inputs for preparation of batch manufacturing documents (BMR/Protocol/Sampling plan) Show less
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Biocon
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India
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Biotechnology Research
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700 & Above Employee
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Principal Scientist
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Aug 2020 - May 2022
•Provides technical leadership for manufacturing. Responsibilities included process and product investigations, continuous process improvement, lifecycle management, technology transfer, and process validation. • Focused on developing QbD risk assessment methodology in collaboration with process development, technical services, and quality assurance. • Collaborates on late-stage/ commercial projects towards establishing risk-based control strategy for process validation, process transfer, and process changes. • Assess formulation development reports. Prepare and execute studies planned to define processing ranges. • Assists in alternate vendor development to validate vendor in defined processing windows. • Leads the technical process evaluation for Technical Transfer projects. Review the existing processes/equipment used and prepare studies to revise the process to align with plant capabilities/equipment/processes and maintain all product attributes. • Leads/ supports cross-functional activities related to development, deployment, and continuous improvement of the QbD approach. • Supports regulatory inspections and filings as an author and reviewer. • Executes laboratory work with moderate direction from senior laboratory personnel. • Familiar with CMC-related activities, including formulation development, process development, and container/closure. • Supports GLP/GMP manufacturing, including the provision of process instructions, batch record review, and acting as a hands-on resource. • Follows all relevant SOP’s and provides cross-functional support as needed. • Perform all work in accordance with cGMP requirements. • Project tracking and updates, as requested for assigned projects. Show less
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Torrent Pharmaceuticals Ltd
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Pharmaceutical Manufacturing
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700 & Above Employee
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scientist II
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May 2017 - Dec 2019
•Design and conduct pre-formulation, formulation, process, stability, and container closure development studies for drug products • Apply scientific fundamentals to solve formulation, stability and manufacturing issues • Represent the formulations function in cross-functional project teams. Develop working relationships with internal colleagues. • Prepare professional technical reports, presentations, and documents for regulatory submissions. • Evaluate functional activities for projects and provide appropriate timelines/resource requirements; executes plans, and coordinate activities in functional area; keep functional activities on schedule. • Conduct research in the areas of formulation modifications and potential new product development. • Develop new applications or customize existing applications to meet specific scientific project needs. • Lead and manage cross-functional efforts to transfer technology from the discovery phase into the development pipeline. • Work with the team to support in-vitro and in-vivo studies. • Makes decisions affecting project directions and maintains project timelines. • Identify functional components and processes to optimize drug product performance. Show less
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Enaltec Labs Pvt Ltd
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India
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Research Officer
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Mar 2015 - May 2017
CMO/CDMO • This position will perform formulation development activities to support early-stage drug product development. • Self-prioritize project work to optimize productivity. This position will perform formulation development activities to support early-stage drug product development. • Proficient knowledge of Microsoft Office Suite and applicable software systems. • Work in a fast-paced, dynamic, entrepreneurial environment. • Designs and executes formulation protocols. • Enabling the delivery of the technical aspects of product development of various oral dosage forms. (Solids: Pellets, tablets; Liquids: oral solutions) • Technology transfer and manufacture of scale-up batches, exhibit batches. • Collaborating with 3rd parties and the broader cross-functional teams to ensure chosen projects are completed on time and with the end consumer goal in mind. • Travel to contract research and manufacturing organizations, as required, to support drug development activities. • Acts as the technical personnel for Client development projects communicates project status and effectively provides technical explanation/rationalization. • Compiling relevant sections of the product dossiers to the agreed timelines. • The development and coaching of direct report(s) to deliver results whilst supporting their personal career and progression needs. • Formulation development skills including understanding of solubility, degradation mechanisms, and kinetics impacting shelf life. Physicochemical properties of a molecule that can impact interactions with packaging, contact parts during manufacture. • Communicate to the project team about the project status and provide technical explanation/rationalization. Show less
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Kopran Ltd
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India
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Research officer in Formulation development
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Sep 2012 - Mar 2015
•Collaborates with and supports all Pharmaceutical Sciences staff to provide material and information in support of product development and manufacturing. • Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes, and equipment. • Execute manufacturing protocols accurately and with limited supervision • Perform multi-step product development process. • Critically review processes and provide input to supervisor. • Perform duties within the GMP, GDP Standards. • Summarize and communicate data results to the team and recommend suggestions to improve operations of product development. • Document all work products in a clear and logical manner using standard scientific reports. • Consult with others to effectively utilize all resources available to achieve results. • Provides leadership by example regarding safe work practices • Utilizes a logical and analytical scientific approach to execute research projects. • Complete assignments in a timely manner, documenting all work accurately and completely. Show less
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Education
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2023 - 2025
Indira Gandhi National University
Master of Business Administration - MBA, Operations management -
2022 - 2023
Indian Institute of Management, Indore
Certificate Programme in Project Management, Project Management -
2009 - 2011
Rashtrasant Tukadoji Maharaj Nagpur University
Master's degree, Pharmaceutics and Drug Design -
2006 - 2009
Rashtrasant Tukadoji Maharaj Nagpur University
Bachelor of Pharmacy - BPharm, Ist class -
2004 - 2006
Directorate of Technical Education
Diploma in Pharmacy, Distinction -
Aadarsh college, Hingoli
High School Diploma, Science -
Nutan vidya mandir, parbhani
Secondary school certificate, Ist class
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