SHWETA ANIL KUMAR
Sharjah
Summary
Dynamic Process Development Scientist with a proven track record at Replimune, Inc., enhancing operational efficiency through meticulous material analysis and risk assessments. Expert in technical troubleshooting and project management, I excel in fostering team collaboration and advancing manufacturing innovations. Skilled in analytical tools and communication, my work has significantly contributed to groundbreaking biopolymer scaffold designs and efficient supplier qualifications.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Process Development Scientist I – Materials Attributes & Technologies
Replimune, Inc.
Framingham
09.2022 - 01.2024
- Conducted technical evaluations for manufacturing operations, focusing on material attributes
- Managed risk assessments, technical documentation, and supplier change notifications
- Troubleshot material-related challenges in drug product production, enhancing operational efficiency
- Collaborated with Manufacturing and QA teams for extractables and leachables analysis
Assistant/Associate Scientist (Contract)
Bristol Myers Squibb
Devens
07.2021 - 08.2022
- Supported lifecycle management of consumables in biopharma manufacturing
- Led change management activities and qualified alternate suppliers for single-use systems
- Authored material specifications and change control documents to ensure compliance
Lab Manager
The University of Texas at El Paso
El Paso
08.2016 - 12.2020
- Devised the technologies for fabricating 'Cardiac Patch' (NHA Funded Project)
- Designed 3D-printed biopolymer scaffolds for cellular applications
- Gained hands-on experience with material characterization techniques and aseptic cell culture
- Trained and mentored students in laboratory operations and research methodologies
Graduate Intern
Pacific Northwest National Laboratory (PNNL)
Richland
01.2019 - 08.2019
- Performed quantification of radiolytic radicals using Electron Paramagnetic Resonance Spectroscopy
- Delivered technical presentations to research teams, fostering knowledge sharing
Education
Master of Science - Project Management
University of The Cumberlands
Williamsburg, KY12.2024
Doctor of Philosophy - Materials Science and Engineering
University of Texas at El Paso
El Paso, TX12.2019
Bachelor of Technology - Chemical Engineering
National Institute of Technology
Calicut, India10.2016
Skills
- Product Feature Card Development
- Customer Service Management
- Product Training
- Technical Troubleshooting
- Communication and Conflict Resolution
- Project Management
- Analytical tools
- Using AI tools
Certification
- Current Good Manufacturing Practice (cGMP) Certification
- Fundamentals of Project Planning and Management – University of Virginia
- Lean Six Sigma Root Cause Analysis & Cause and Effect Matrix
- Member, American Institute of Chemical Engineers (AIChE)
- Associate Member, The Institution of Engineers (India)
Softwareandtools
ImageJ, Kaleida Graph, Flow Cytometry Software, C++, SQL, R Studio, Microsoft Office, Supply Chain Management Tools
Achievementsandprojecthighlights
- Spearheaded successful troubleshooting of single-use material challenges, ensuring timely production.
- Delivered impactful product training sessions, enhancing team proficiency in technical processes.
- Developed innovative 3D-printed scaffolds, paving the way for advancements in tissue engineering.
Timeline
Process Development Scientist I – Materials Attributes & Technologies
Replimune, Inc.
09.2022 - 01.2024
Assistant/Associate Scientist (Contract)
Bristol Myers Squibb
07.2021 - 08.2022
Graduate Intern
Pacific Northwest National Laboratory (PNNL)
01.2019 - 08.2019
Lab Manager
The University of Texas at El Paso
08.2016 - 12.2020
Master of Science - Project Management
University of The Cumberlands
Doctor of Philosophy - Materials Science and Engineering
University of Texas at El Paso
Bachelor of Technology - Chemical Engineering
National Institute of Technology
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