Prabhakara Prabhu

Experience

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  Srinivas Colege of Pharmacy

  Jul 2006 - Mar 2008

  Lecturer

  Teaching the graduate (B. Pharm) students on the subjects related to Pharmaceutics (1st year through 4th year).Engaging students in various non-curricular activities for their overall growth.

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  Strides

  Apr 2008 - Mar 2010

  Executive - Technology Transfer (Injectables).

  Technology Transfer, Scale-Up, Process Validation:Responsible for execution of the Scale-up, Technology Transfer and Process Validation of Sterile dosage formulations (liquid injections, Lyophilised products, Dry Powder products) being a team member.Responsible for having the required documentations in place for execution of scale-up, exhibit and process validation batches.Responsible for troubleshooting the various manufacturing process related issues/problems and analytical variance occurred during Exhibit/Optimization/validation Batches manufacturing at the manufacturing location being a team member. Show less

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  Lupin

  Mar 2010 - Mar 2013

  Process Development, Scale-Up, Process Validation:Responsible for managing the Scale-up, Technology Transfer and Process Validation of Sterile dosage formulations (ophthalmic and otic). Responsible for end to end execution of activities related to Scale-up, Technology Transfer and Process Validation in coordination with various cross functional teams. Ensuring the Process Development is successful by implementing the elements of QbD. Responsible for ensuring Quality management System activities (change controls, deviation/incidents, training) related to Process Development as per the approved corporate SOPs.Responsible for having the required documentations in place for execution of scale-up, exhibit and process validation batches.Responsible for troubleshooting the various manufacturing process related issues/problems and analytical variance occurred during Exhibit/Optimization/validation Batches manufacturing at the manufacturing location.Identifying the training need of the Process Development personnel and managing the QMS related activities of the Process Development department. Show less Process Development, Scale-Up, Process Validation:Responsible for managing the Scale-up, Technology Transfer and Process Validation of Sterile dosage formulations (ophthalmic and otic). Responsible for end to end execution of activities related to Scale-up, Technology Transfer and Process Validation in coordination with various cross functional teams. Ensuring the Process Development is successful by implementing the elements of QbD. Responsible for ensuring Quality management System activities (change controls, deviation/incidents, training) related to Process Development as per the approved corporate SOPs.Responsible for having the required documentations in place for execution of scale-up, exhibit and process validation batches.Responsible for troubleshooting the various manufacturing process related issues/problems and analytical variance occurred during Exhibit/Optimization/validation Batches manufacturing at the manufacturing location. Show less

  • Sr. Executive - Process Development (Sterile)

    Apr 2012 - Mar 2013

  • Executive - Process Development (Sterile)

    Mar 2010 - Mar 2012
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  Dr. Reddy's Laboratories

  Mar 2013 - Jul 2022

  o Formualation development of injection drug products and and nasal spray products as per the QTTP. o Process development of injection drug products and and nasal spray products and transfer of the same to manufacturing sites. o Use of QbD principles to optimize the drug product formulation and its process development. o Regulatory Module writing (CMC) and Handling Queries of NDA – 505B(2) – filing.o Responding timely to the queries received from the FDA during the review of the NDA file.o Experience in developing drug-device combination products from lab to launch including management of commercial supplies. Successful examples include the development and commercialization of Zembrace® (autoinjector) and Tosymra® (Nasal Spray). Show less o Formualation development of injection drug products and and nasal spray products as per the QTTP. o Process development of injection drug products and and nasal spray products and transfer of the same to manufacturing sites. o Use of QbD principles to optimize the drug product formulation and its process development. o Regulatory Module writing (CMC) and Handling Queries of NDA – 505B(2) – filing.o Responding timely to the queries received from the FDA during the review of the NDA file. Show less

  • Tech Lead - Process Development

    Jan 2021 - Jul 2022

  • Sr. Scientist II

    Jul 2019 - Dec 2020

  • Sr. Scientist I

    Jul 2015 - Jun 2019

  • Scientist - Formulation R&D

    Mar 2013 - Jun 2015
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  AUROBINDO PHARMA LTD

  Jul 2022 - now

  Group Leader - Nasal Formulations

  - Leading a team responsible for formulation and process development of generic nasal spray drug products (multi dose and unit dose) for US and global markets and transfer of the same to manufacturing site.- Monitoring the development plan and its execution and review of data and providing the required guidance to the team.- Coordination with various cross functional team such as analytical, regulatory, sourcing, IP and manufacturing to provide technical solutions for the product under development. - Alternate vendor development for active and critical excipients for business continuity. Show less