• Leading projects including lab work and model/simulation; and in proposal preparation on new projects including brain-storming sessions for ideation, literature research, and critical analyses/tests to evaluate new potential solutions.• Investigation into sustainable biomass production from various sources of cellulosic material, researching end-stage uses, production scaling, yield enhancement, and material characterization based on end-use needs

Single Use Component Remediation - Qualification of SUT program for all unit operations for MAPs process to support product release. • Authoring and Reviewing of: Design Summary Reports, FMEAs, Risk Assessment Reports, User Requirement Specifications, Design Qualification Reports • Single Use Drawing, Supplier Sub-Component and Compliance Data Gathering and Organization • Management of sub-component data to include supplier information, materials, extractables data • Supplier outreach for qualification data as outlined by client’s Quality Framework Standard• Establish timely communication with Single Use Suppliers to ensure delivery of validation information within schedule. • Creation and Approval of Material Specifications.

• Designed, executed, and documented experiments for characterizing and developing processes for generating and purifying mRNA.• Authored process development reports for establishing the process steps and parameters to mRNA purification.• Performed screenings and column packing for chromatography process steps on HIX, AEX, SEC, and MMC resins for mRNA separations.• Coordinated with vendors for acquiring lab materials and equipment to align with scaling up of operations.• Lead experiment for studying the risk of removal to polishing step which translated to saving thousands of dollars and hours of manpower per batch at manufacturing scale.• Trained personnel on theory and operation of TFF and chromatography equipment and HMI.• Supported the authoring of manufacturing documentation for the operation of equipment and processes.• Supports the manufacturing organization with the operation of equipment and processes.

• Specialized in reaction and filtration processes required for production of LNP and mRNA.• Updated automated methods on Millipore TFF skids by designing step criteria and actions based around set parameters in technology transfers.• Entrusted by managerial, digital, and quality staff with elevated accesses to production equipment, manufacturing execution system, business management software, quality management, and computerized maintenance management system.• Aided in the creation and execution of test protocols for reduction of process residue when breaking down single-use equipment and for automation improvements regarding critical valve alarms, resulting in fewer deviations.• Constructed an active batch-tracking production sheet to maximize output across 4 assembly lines while considering equipment vacancy, raw material availability, and resources for maintenance/calibration.• Trained dozens of manufacturing associates on the direct and ancillary processes relating to LNP production; the use of supporting digital systems relating to data trending, sample tracking, batch execution, maintenance management; and business tools used to exchange information across shifts, departments, and work centers.• Investigated automated methods across multiple skids and compared them between machines' phase reports and cGMP documents to ensure their alignment.• Collaborated with MSAT, Digital, and Quality teams in critical scenarios.• Aided in IQ/OQ/PQ of GMP equipment for scaling up production prior to release.• Assisted in validation for PPQ of new production trains via Kneat validation system.• Filtered and dispensed final products into collection bags for storage in freeze/thaw units.• Helped perform the Factory and Site Acceptance Tests for LNP Formulation Skids.• Tracked sample result status/updated equipment logbooks for GDP purposes using LIMS.

• Walking down equipment to validate that piping matched what was on its respective drawing and correcting any discrepancies.• Ordering equipment needed for the suites, coordinating with vendors to determine the best course of action installing them.• Tagging parts and equipment to integrate a better, uniform means of tracking them and noting them on a P&ID.• Inspecting vessels and piping to see if they need special cleaning or bending• Writing work order requests for multiple purposes: o Preparing equipment for product changeovers o Generating equipment tags o Integrating new pieces of equipment into the parts system• Created a process flow diagram of the entire clean suite to be used by the engineering personnel for visual reference in their work.• Devised a production schedule chart to use equipment, materials, and personnel in a more efficient manner. o This involved a lot of investigating trends for CIP processes to find out how much WFI each uses per piece of equipment. • Performed equipment history data trending to investigate issues with a viresolve skid.• Composed a comprehensive guide for handing over equipment through the manufacturing control system to maintain GMP compliance.• Wrote preventative maintenance task-lists for vessels and filtration skids so they would receive proper sustainability work.• Drafted P&IDs for incumbent skids through usage of MS Visio• Investigated piping for standing water after CIP blowdown procedures and edited the respective phase tables to correct for required step changes.• Presented high-level safety report summaries to managerial staff.