Performs daily operations in Solution's Prep (Batch/Transfer, Clean in Place, Steam in Place) according to Standard Operating Procedures (SOPs) while strictly maintaining GxP guidelines
Aseptic preparation/transferring of specialized mammalian cell culture media and specialized clarification, purification, and final formulation buffers ranging from 420 to 22,000 Liters
Proficient in the utilization and standardization of pH/conductivity probes, Blood Gas Analyzers, and Osmometers
Monitors critical processes, performs basic troubleshooting, and generates process-related trends utilizing Delta-V, and PI Vision
Comprehensive understanding of upstream and downstream processes while working alongside supporting departments and scheduling to ensure operational needs are met
Acted as the primary contact for media/upstream and buffer/downstream support during operations, enhancing communication and coordination.
Ensures timely execution of media and buffer operations, maintaining strict adherence to cGMP guidelines for compliance.
Regularly initiates and authors quality incidents and deviations while working alongside PQA for record accuracy and closure within a timely manner
Performs manufacturing reviews for both GMP documentation and Electronic Batch Records while adhering to GDP principles
Routinely participates in third-party documentation walkthroughs prior to shift-turnover
Facilitates macro and micro turnovers, promoting operational efficiency and adherence to cleanliness standards.
Works alongside fellow peers daily while utilizing effective teamwork, and communication skills to ensure product quality is always met
Adheres to housekeeping efforts by generating work orders, ensuring airlocks are clear and organized, and performing routine material orders in Kanban and routine scrap within MES in both Media and Buffer suites
Experience with working within Maximo, and completing asset-related CM/PM Work Orders in a timely fashion adhering to applicable procedures
Experience with SOP revisions and reviews for department specific procedures
Senior Site Specialist - Process Development
Thermo Fisher Scientific
West Greenwich, RI
02.2023 - 01.2024
Aseptic preparation of specialized mammalian cell culture media, and buffers for all Process Development and Pilot Plant needs while adhering to GLP and GDP guidelines
Executed solution's preparation tasks, including pH titration, osmolality adjustment, and sterile filtration, to meet Process Development requirements
Operated large-scale media and buffer batching systems, handling tanks ranging from 300 to 2,500 liters
Served as primary client contact for all Process Development solution preparations, ensuring alignment with client specific needs
Experience with shake flask sampling/passaging, and bioreactor monitoring/sampling/feeds for in-process mammalian cell cultures
Experience with both full building and take-down of small scale bioreactors(1 to 5 Liters)
Operation of CIP/SIP laboratory skids and prep vessels
Handled toxic and hazardous raw materials, solutions, and samples on a daily basis, adhering to safety protocols.
Performs complex calculations based on molarity, percent by volume, dilutions, ppm, and ppb
Proficient with the utilization and calibration of laboratory instrumentation including, but not limited to: Blood Gas Analyzers, Osmometers, pH/Conductivity/DO2 Probes, peristaltic pumps, vacuum filters, Biosafety Cabinets, Cedex Hires and Bio HT Cell Culture and metabolite Analyzers
Research and Development Intern: Team Coating and Film Processing
BASF-Ludwigshafen
Rhein
03.2022 - 08.2022
Spearheaded change in experimental design and sample formulation throughout the entire experiment
Performed tests that measured the adhesive and cohesive strength, CO2 absorption to surface area, overall shear rate, and general ability to coat of each sample formulation
Generated and tested film/coating samples on multiple substrates to support research objectives
Collaborated with engineers, technicians, and interns to analyze results in a bilingual environment
Demonstrated clear and concise communication amongst fellow peers for future direction within field of research
Organized and presented data findings using Microsoft Office to inform research decisions
Followed technical instructions and interpreted real-world data in a foreign language
Recorded project details and data sheets for future reference
Education
Bachelor of Science - Cellular and Molecular Biology
The University of Rhode Island
Kingston, RI
08-2022
Bachelor of Arts - German
University of Rhode Island
Kingston, RI
08-2022
Skills
Aseptic processing
cGMP/GLP documentation
Delta-V execution
Process Troubleshooting
Quality Assurance
LIMS/MES/HLEE
Data collection
Technical writing
Microsoft Office
SharePoint
Cross functional teamwork
Effective communication
Personal Information
Work Permit: Authorized to work in the US for any employer
Visa Status: Authorized to work in the US for any employer
Timeline
Manufacturing Associate II
Amgen
01.2024 - Current
Senior Site Specialist - Process Development
Thermo Fisher Scientific
02.2023 - 01.2024
Research and Development Intern: Team Coating and Film Processing
BASF-Ludwigshafen
03.2022 - 08.2022
Bachelor of Science - Cellular and Molecular Biology