Detail-oriented R&D Formulations Associate proficient in supporting drug product, drug substance manufacturing, and maintaining compliance with FDA, cGMP, and ICH regulatory standards.
Overview
3
3
years of professional experience
Work History
R&D Formulations Associate - Protein Product Development
CSL BEHRING
KANKAKEE, IL
04.2024 - Current
Conducted process scale-up and production of drug biologics from 20L to 1000L for clinical trials, leveraging forward thinking to implement changes in protein purification that significantly increased productivity.
Executed GMP production runs of biopharmaceutical products, meticulously following SOPs and manufacturing batch records while operating advanced equipment, including AKTA chromatography skids and filtration systems.
Collaborated closely with R&D and Quality teams to perform routine manufacturing tasks under cGMP guidelines, employing various protein purification techniques.
Manufacturing Associate II (Upstream, Downstream and Drug Substance Operations Lead)
KASHIV BIOSCIENCES
CHICAGO, IL
06.2023 - 02.2024
Employed aseptic techniques for scale-up operations, including 2L shake flask setups and inoculation of 10L and 250L bioreactors, along with daily sampling and filtration of buffers.
Involved in all phases of biopharmaceutical production, including upstream fermentation, protein refolding, downstream chromatography, and preparing media and buffer solutions.
Conducted in-process testing (pH, conductivity, cell count, etc.), maintained accurate cGMP documentation, and consistently received above-average performance reviews.
Bioprocess Engineer I Upstream
NOVARTIS GENE THERAPIES
LIBERTYVILLE, IL
04.2021 - 02.2023
Mastered aseptic techniques in ISO 5, 6, and 7 environments for cell culture, recovery, clarification, and purification in the production of Zolgesma gene therapy for Spinal Muscular Atrophy.
Engaged in upstream manufacturing, preparing media and buffers, cross-training in bioreactor processes, and troubleshooting equipment while ensuring compliance with cGMP and regulatory standards.
Assembled and operated bioreactors, TFF systems, and Millistak Pod Depth Filtration equipment, collaborating effectively with the team to maintain quality and complete processes in a fast-paced environment.
Education
Bachelor of Arts - Biology
Lake Forest College
Lake Forest, IL
01-2020
Skills
Manufacturing Operations
Technical Documentation
Environmental Monitoring
Regulatory Knowledge
Collaboration
Attention to Detail
Project and Inventory Management
Safety Compliance
Research & Academia
Biology 408: Senior Seminar
Achieved an A in BIOLOGY 408: Senior Seminar, the highest-level biology course, demonstrating strong academic performance.
Wrote a 27-page senior paper on “Entheogens and their Religious Impact on Ancient Civilizations,” showcasing thorough research and time management skills.
Delivered two one-hour seminars, requiring extensive preparation and a deep understanding of the subject, with top grades on all assignments.
Research Project
Co-authored a published scientific paper on the effects of decitabine treatment on methylation in HCT-116 colorectal cancer cells.
Proficient in molecular biology techniques, including pipetting and PCR (Polymerase Chain Reaction).
Collaborated with a team of 10 and a professor to develop all sections of the paper, including introduction, methods, data analysis, discussion, and conclusion.