Gopinath Rongala
Senior Formulation Scientist at Venatorx Pharmaceuticals, Inc.- Claim this Profile
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Credentials
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CGMP
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Experience
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Venatorx Pharmaceuticals, Inc.
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Senior Formulation Scientist
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Jan 2021 - Present
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Quotient Sciences
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Staff Formulator
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Oct 2020 - Dec 2020
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Staff Formulator
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Jun 2017 - Oct 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.
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Scientist I
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Apr 2014 - Jun 2017
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).
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Long Island University
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United States
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Higher Education
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700 & Above Employee
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Graduate Assistant
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Aug 2012 - Dec 2014
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Education
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Long Island University, Brooklyn Campus
Master of Science (M.S.), Industrial pharmacy -
V.l. College of pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy