Rebekkah Golisch
Catalent Pharma Solutions
Sun Prairie,WI
5
years of professional experience
Results-oriented Downstream Manufacturing Technician with over two years of experience in process design and cGMP manufacturing. Certified trainer skilled in managing communication between trainers and participants, enhancing training programs, and driving operational efficiency. Focused on leveraging technical expertise to facilitate continuous improvement in manufacturing processes.
Work History
Downstream Manufacturing Technician
2 Years 3 Months- Operated equipment in a cleanroom environment using carefully selected techniques and knowledge of equipment functions for in-vitro transcription (IVT) reactions, chromatography, tangential flow filtration (TFF), viral filtration, and column packing and qualification for downstream purification and mRNA production processes.
- Trained new employees on use of equipment and processes pertaining to manufacturing activities. Led teams of operators in daily processing activities.
- Accurately followed manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs).
- Identified deviations from intended procedures and implemented corrective actions through Rapid Response process, ensuring compliance and quality in production.
- Executed cleanroom housekeeping tasks, including room and equipment cleaning, waste disposal, and 5S maintenance, to uphold a controlled manufacturing environment.
Research Associate
1 Year 7 Months- Combined knowledge of laboratory processes with results from trial batches to write 12 sequential protocols that result in more than 3 sequential batches that meet cGMP requirements.
- Reviewed manufacturing process of biologic pharmaceuticals using root cause analysis to implement quality improvement plan, enhancing regulatory compliance and ensuring patient safety.
- Combined knowledge of laboratory processes with trial batch results to write 12 sequential protocols, facilitating production of 3 compliant batches that meet cGMP requirements.
- Documented batch production activities and cGMP data, adhering to Good Documentation Practice (GDP) guidelines to maintain compliance.
Research Technician
1 Year 2 Months- Operated pilot plant according to test conditions, ensuring optimal maintenance of related equipment.
- Analyzed real-time data from pilot plant to assess experimental outcomes and identify troubleshooting needs.
- Operated pilot plant per test conditions and maintained related equipment efficiently.
- Created feed solutions and improved catalyst loading methods.
- Executed experiments as per instructions and compiled data in Microsoft Excel for further analysis.
Education
Bachelor of Science - Chemical Engineering
Skills
Pilot Plant Modification
Good Documentation Practice
Regulatory Reporting
Equipment Calibration
Hazard Analysis
Data Analysis
Technical Writing
BMRAM
LIMS
DeltaV
Documentation standards
Timeline
Downstream Manufacturing Technician
Catalent Pharma Solutions
05.2024 - CurrentRead More
Research Associate
VGSK Technologies
09.2022 - 04.2024Read More
Research Technician
Virent Inc.
07.2021 - 09.2022Read More
Michigan Technological University
Bachelor of Science from Chemical Engineering
Read More