Karthick Kumarasen Ravi
Allentown,PA
Summary
Dedicated and accomplished Scientist in Product Development with extensive expertise in Pharmaceutical Sciences, specializing in Pharmaceutics, Drug Delivery, Pharmaceutical Formulations, and Controlled Drug Delivery Systems. Proficient in research involving Nano formulations, dry coating, and oral drug delivery of small molecules. Proven ability to manage diverse projects, teach, and lead teams while meeting deadlines effectively. An analytical thinker with a strong scientific background, aiming to contribute to innovative solutions in the pharmaceutical industry.
Overview
7
7
years of professional experience
Work History
Scientist
Genus Lifesciences Inc
01.2022 - Current
- Successfully managed a team of eight full-time employees, focusing on strategic task allocation, proactive troubleshooting, and comprehensive coordination to ensure seamless operations
- Led R&D initiatives in the formulation of oral solid dosages, including tablets, capsules, oral solutions, and chewable tablets, with specialization in anti-seizure medications, analgesics, thyroid treatments, and amino acids
- Spearheaded pre-formulation and formulation studies, driving the development of stable drug products and conducting comprehensive technical risk assessments
- Designed and executed experimental studies to evaluate APIs, excipients, and packaging components, ensuring alignment with FDA regulatory requirements
- Analyzed data, authored detailed reports for regulatory submissions, and reviewed clinical study data for FDA approval
- Investigated product failures, addressing quality, potency, and visual characteristic concerns, while implementing corrective actions
- Led troubleshooting efforts for technical and manufacturing challenges, ensuring efficient resolution
- Prepared manufacturing trial documentation for pilot-scale runs and scale-up operations, aligning with industry best practices
- Collaborated cross-functionally to interpret data, prepare technical reports, and support validation processes for FDA applications
Scientist
Aucta Pharmaceutical Inc
07.2021 - 12.2021
- Directed R&D projects focusing on the formulation and pre-formulation of oral solid dosages, particularly phosphonic antibiotics
- Conducted thorough analyses of experimental results, preparing comprehensive reports and technical documents for FDA submission
- Facilitated the identification and resolution of product development challenges, ensuring adherence to quality and regulatory standards
- Managed the preparation of technical documentation essential for drug product filing processes
- Played a pivotal role in troubleshooting complex scientific issues, leveraging expertise in assays and instrumentation
- Stayed at the forefront of scientific advancements by reviewing relevant literature, applying new insights to ongoing projects
Research and Development Chemist
Novitium Pharmaceutical LLC
05.2020 - 06.2021
- Designed and performed advanced chromatographic techniques, including reverse-phase and ion-exchange chromatography, using Empower 3 software for a variety of pharmaceutical compounds
- Supported the formulation development of solid dosage products through excipient compatibility studies, impurity profiling, dissolution testing, and reverse engineering
- Executed cleaning verifications of manufacturing units to validate cleaning procedures' efficacy and compliance
- Provided analytical technical support for R&D product development, ensuring robust and reliable methodologies
- Documented critical observations and developed comprehensive reports for analytical testing to support regulatory submissions
- Led investigations into manufacturing deviations, identifying root causes and implementing corrective actions to prevent recurrence
Research Assistant
Energetic Materials, New Jersey Institute of Technology
02.2019 - 06.2019
- Worked on Boron-Bismuth Fluoride composites to understand its reactions leading to their ignition, where composites are prepared using mechanical milling using Shaker mill
- Further extracting sample and characterizing sample using Wire Ignition Test, Laser Combustion, DSC (Differential Scanning Calorimeter)
Research Assistant
New Jersey Center for Engineered Particulates, NJIT
06.2018 - 12.2018
- Dry coating of cohesive powder to increase its flowability for better handling, easy storage and enhanced properties for making tablets using compression
- Coated the given API with Magnesium stearate using Lab Ram high resonant acoustic mixture at various time period and observed its bulk density and Flow function coefficient using FT4 Powder Rheometer
- Used carver Presser for making tablets to check its tensile strength
- During my project I leant Rodeos Particle size analyzer and Sieve Shaker
- Drug analyzes for determining the quality of tablet specifically, pain killer by determining assay content of acetaminophen using HPLC (High performance Liquid chromatography)
- Determined the presence of the analytes like Dichromate and Permanganate by UV Spectroscopy in the given sample
Education
Master of Science - Project Management
Harrisburg University of Science and Technology
Harrisburg, PA10.2024
Master of Science - Chemical Engineering
New Jersey Institute of Technology
Newark, NJ12.2019
Skills
- Formulation Development
- Oral Solid Dosage Forms
- Immediate Release Tablets
- Modified Release Tablets
- Nanoparticles
- Capsules
- Liquids
- Oral Delivery of Poorly Soluble Drugs
- Microfluidizer
- Spray Dryer
- Tablet Press
- Ultra Turrex Homogenizer
- Dissolution with Autosampler
- Comil
- Fluidized Energy Mill
- Blender
- Coater
- High Shear Granulator
- Fluid Bed
- Granulator
- Hardness
- Disintegration
- Friability
- HPLC -UV-PDA
- DLS
- Rheometer
- DSC
- FT-IR
- UV Spectroscopy
- Karl Fisher
- Dissolution
- Blending
- Coating
- Moisture Content
- Analytical Skills
- Problem-Solving Skills
- Teamwork
- Communication Skills
- Organization Skills
- Documentation Skills
- Technical Writing Skills
- Empower
- Microsoft Office
- Windows
- Mac
- Instruments Software
Timeline
Scientist
Genus Lifesciences Inc
01.2022 - Current
Scientist
Aucta Pharmaceutical Inc
07.2021 - 12.2021
Research and Development Chemist
Novitium Pharmaceutical LLC
05.2020 - 06.2021
Research Assistant
Energetic Materials, New Jersey Institute of Technology
02.2019 - 06.2019
Research Assistant
New Jersey Center for Engineered Particulates, NJIT
06.2018 - 12.2018
Master of Science - Chemical Engineering
New Jersey Institute of Technology
Master of Science - Project Management
Harrisburg University of Science and Technology
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