Gopinath Rongala

Experience

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  Long Island University

  Aug 2012 - Dec 2014

  Graduate Assistant
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  Aurobindo Pharma USA, Inc.

  Apr 2014 - Jun 2017

  Scientist I

   Supported new product development deliverable initiatives. Led formulations on modified release dosage form such as Controlled release, Extended release, and Delayed release processes. Tracked relevant information related to product development, sample development & experimental design. Developed scientific reports, regulatory documents and patent applications. Involved in developing corporate standards including safety, compliance, materials management and Class II substances. Developed oral solid dosage forms by wet granulation and direct compression formulations. Collaborated with Freund Vector in Iowa to work on Granurex rotor processor and developed a drug layering technique for a project to meet the dissolution criteria and to minimize the processing time. Successfully led and executed 30 plus drug products and processes that were approved by the FDA (CBE 30).  Led formulation activities on various drug product manufacturing batches to improve the process and minimize lead times. Developed and optimized multiple analytical methods and techniques. Monitored Exhibit and Validation batch processes in manufacturing. Involved in troubleshooting of various problems in Compression and Coating in manufacturing.  Prepared and reviewed Validation reports, Exhibit and Commercial batch records. Designed and optimized Manufacturing process for tablets and capsules. Prepared Investigation reports Change controls and Deviations.  Prepared and reviewed Batch Manufacturing records, Technical Transfer documents, Standard Operating Procedures (SOP’s).  Analyzed and interpreted the data generated from techniques like HPLC, chromatography, Spectroscopy, Scanning Electron Microscopy (SEM). Show less

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  Quotient Sciences

  Jun 2017 - Dec 2020

   Develop and implement experimental R&D ways to seek solutions during the course of method and analytical development. Develop regulatory documents, SOPs, product development reports, scientific study reports and presentations. Develop and analyze the outcomes and implement next level experiments based on the meta data, analytical data and historical data. Worked with CROs and cross functional teams and presented the R&D metrics. Identify, develop, optimize and validate existing and new analytical methods. Prepare and review SOP’s, batch records, protocols, development reports and QI’s. Prepare and monitor stability protocols per ICH guidelines.  Evaluate stability results of formulation prototypes and clinical supplies. Perform pre-formulation, formulation, manufacturing process development, optimization for various batch sizes (lab to production scale). Involve in chemical structural analysis using different analytical instruments. Analyze Physical and chemical properties of drug substances, APIs and excipients. Develop formulations (Solid Amorphous Dispersions, Modified Release Dosage form, Immediate Release) and manufacturing processes for pharmaceutical dosage forms ranging from early phase to registration. Work on NME’s and ANDA’s from early phases to a viable robust processes and stable formulation.  Lead activities related to test methods and product transfers for manufacturing of products. Work on Translational Pharmaceutical products which run on fast-track formulation development and dosing in patients (FIH). Analyze PK/PD profiles and optimized the solid dosage characterizations and formulation.  Involve in planning project activities in coordination with management and team. Work with cross functional teams and led interactions with Clients, Analytical Scientists and QA. Train new staff, operators and team on new initiatives and processes. Show less

  • Senior Staff Formulator

    Oct 2020 - Dec 2020

  • Staff Formulator

    Jun 2017 - Oct 2020
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  Venatorx Pharmaceuticals, Inc.

  Jan 2021 - now

   Responsible for formulation development of oral dosage forms from pre-clinical development through later phases of a clinical program. (BARDA, NIH/NAID) Responsible for developing analytical methods for the early phase and late phase formulations. Responsible for designing, preparing, and characterizing IND-enabling formulations and formulations for post-IND clinical development and registration.  Responsible for experimental design, execution, data analysis, generation of scientific reports, and coordination of studies with other technical groups.  Specify procedures for preparation of formulations for preclinical and clinical administration.  Collaborate with colleagues in Pharmaceutical Product Development to author/ review CMC sections and/or relevant source documents to support regulatory submissions (Background Packages, INDs, NDAs).  Manage CRO’s/ CDMO’s for R&D and GMP manufacturing batches including reviewing batch records, technology transfer documents, deviations, change controls, etc. Visiting CRO’s/ CDMO’s to observe and understand the challenges faced to ensure a robust process and a smooth transition to next phase (laboratory scale to production scale). Collaborate with project teams to meet project objectives, budget, and timelines. Show less

  • Senior Formulation Scientist II

    Jan 2024 - now

  • Senior Formulation Scientist, CMC

    Jan 2021 - Feb 2024