Summary
Overview
Work History
Education
Skills
Timeline
Generic

Sriram Ravula

Summary

Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and exceptional interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.

Overview

6
6
years of professional experience

Work History

R&D Intern

Stira Pharmaceuticals LLC
09.2024 - 12.2024
  • Follow up with Purchase and Analytical departments for timely arrival of materials and results.
  • Execution and evaluation of developmental studies like SS316 vessel compatibility filter compatibility, tubing compatibility, pH suitability study, freeze thaw, photo stability, temperature excursion, autoclave suitability, rubber closure suitability, antimicrobial efficacy study, physiological solution compatibility, etc.
  • Conducting stability studies for various formulations as per ICH guidelines.
  • Maintenance of equipment and labware to conduct the R&D trials.
  • Formulation development studies (Project initiation, Design, Execution, scale-up and trouble shooting).


R&D Intern

Apicore LLC
05.2024 - 09.2024
  • Initiation of new projects and preparation of presentations, RFQs, budget preparations, and Summary documents.
  • Actively involved in the development of ophthalmic and injectable products from literature search to regulatory filing of the product.
  • Execution of developmental batches, Preparation of study protocols, and review of the protocols from the external CMO'S.
  • Troubleshooting the problems encountered during development.
  • Preparation of technology transfer documents including MFC, BMP, SSP, BOM risk assessment reports etc., and review of documents received from the received from CMO site.
  • Preparation of justification documents and write-ups for the queries/deficiencies received from regulatory agencies.
  • Hands-on and experience on Netzsch Nano mill, High Speed Homogenizer (IKA Homogenizer, Megatron -MT 3000 & MT 5100s) used for development of complex formulations like Suspensions and emulsion.
  • Preparation of departmental SOPs, new Instrument/Equipment related and its compliance.
  • Maintenance of equipment and lab ware to conduct the R&D trials. Follow up with Purchase and Analytical departments for timely arrival of materials and results.
  • Maintenance of Laboratory notebooks, logbooks and calibration records for the equipment's and instruments in formulation department

Research Associate

Orbicular pharmaceutical technologies
03.2021 - 01.2023
  • Experience in development of sterile products including simple Injectable, Otic Suspensions, Solutions and Ophthalmic Suspensions
  • Well versed with regulatory guidelines and requirements
  • Preparing SOPs for Documentation system related and new Instrument/Equipment related and its compliance
  • Preparation & maintenance of the development batch compilation data and other documentation during development
  • Execution and evaluation of developmental studies like SS316 vessel compatibility filter compatibility, tubing compatibility, pH suitability study, freeze thaw, photo stability, temperature excursion, autoclave suitability, rubber closure suitability, antimicrobial efficacy study, physiological solution compatibility, etc
  • Conducting stability studies for various formulations as per ICH guidelines
  • Maintenance of equipment and labware to conduct the R&D trials
  • Follow up with Purchase and Analytical departments for timely arrival of materials and results
  • Prototype formulation development for the above dosage forms and monitoring of scale up batches during technology transfer to production Plant
  • Keeping track of stability schedule for the developed formulations and troubleshooting if necessary
  • Maintenance of Laboratory notebooks, logbooks and calibration records for the equipment’s and instruments in formulation department.

FR&D TRAINEE

Caplin steriles
02.2020 - 03.2021
  • Initiated, actively involved and executed developmental batches for Liquid injections for global (EU/US/ROW) Market
  • Development of Lyophilized injectable drug products
  • Hands on experience on Freeze Drying Microscope (LINKAM), Lyostar III (SP scientific) Crucial role in performing Literature and Patent Search, Review and preparation of Summary and related Product Development Strategy documents (like Development Strategy Note; Quality Risk Assessment reports etc.) Reference Product Evaluation
  • Formulation development studies (Project initiation, Design, Execution, scale-up and trouble shooting).

Project Trainee

Wockhardt ltd
08.2018 - 01.2020
  • Assisted in developing presentations for executive-level review.
  • Provided administrative support for the project team, including scheduling meetings, organizing documents, and taking minutes.
  • Collaborated with cross-functional teams to ensure successful delivery of projects.

Education

Master’s Degree of Regulatory Affairs (DRA) -

Long Island University
Brooklyn, NY
12.2024

Bachelor’s Degree of Pharmacy (B.PHARM) -

Vignan Pharmacy college
05.2017

Skills

  • MS Office:Highly skilled in utilizing Microsoft Word, Excel, and PowerPoint, showcasing proficiency in effectively utilizing these software tools for various tasks and projects

Timeline

R&D Intern

Stira Pharmaceuticals LLC
09.2024 - 12.2024

R&D Intern

Apicore LLC
05.2024 - 09.2024

Research Associate

Orbicular pharmaceutical technologies
03.2021 - 01.2023

FR&D TRAINEE

Caplin steriles
02.2020 - 03.2021

Project Trainee

Wockhardt ltd
08.2018 - 01.2020

Bachelor’s Degree of Pharmacy (B.PHARM) -

Vignan Pharmacy college

Master’s Degree of Regulatory Affairs (DRA) -

Long Island University

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Sriram Ravula