Casey Irwin Email & Phone Number

Lawrence Township, Nj, Us

Process Engineer supporting all MSAT activities at CMOs to ensure uninterrupted clinical/commercial vector manufacturing and supply.Specific accomplishments include:o Providing technical process support for routine clinical/commercial batches and assisting QA with on time closure of all quality system records such as deviations, CAPAs and owning change controls.o Employing tools to monitor vector manufacturing process performance and enable understanding of process capability.o Owning the execution of process control strategies including execution of process risk assessments and CPV.o Writing Critical reports and other documents, including CPV reports to ensure the manufacturing process is in a state of control.

Lawrence Township, Nj, Us

Team lead managing floor operations for CAR-T Cell Therapy manufacturing, where a high level of proficiency is required for technical aseptic operations, cGMP, training, and personnel management. Specific accomplishments include:o Executing critical formulations and viral vector preparation in ISO 5 environment for CAR-T production.o Training operators for proficiency in aseptic operations and process systems, such as: Syncade MES, Oracle interfaces, BMRAM, etc.o Performing and overseeing the completion of assignments per written procedures, where attention to detail is critical and the ability to recognize deviation from accepted practice is required.o Creating positive team environment, where combined contribution and collaboration result in an exceptional standard and reliable task completion.o Adhering to good manufacturing practices and standard operating procedures in compliance with all regulations, maintaining zero human avoidable deviations. o Assisting with the revision and creation of process documents (SOPS, work instructions, etc.) and managing document workflows in document systems.

Bothell, Wa, Us

Executing cell culture bioprocess operations in a GMP facility utilizing aseptic technique, attention to detail, and standard industry practices to ensure timely product delivery and compliance with company standards and the FDA. Specific accomplishments include:o Performing GMP manufacturing operations safely, reliably and in compliance with standard operating procedures and batch records.o Completing required processing documentation including deviation reports, change control, product change over, etc.o Performing bioprocess operations such as sampling, filtration, purification, cell culture, and recovery.o Cleaning, assembling/disassembling, sterilizing, and operating primary process equipment.

Arlington, Va, Us

Medical logistics specialist for the 551st Medical Supply Warehouse engaging in the receipt, storage, and distribution of time sensitive medical supplies throughout Afghanistan- managing 100% cyclic inventory of vault and cold chain items.Specific accomplishments include:o Facilitating the Guaranteed Returns Exchange Program (GRX), in which over $625,000 worth of pharmaceuticals from units, aid stations, and hospitals has been turned into government funds.o Directing medical materials for over 50 customers and providing technical direction on stock rotation, destruction, and inventory management.o Managing the receipt, storage, and distribution for all controlled substances supplied to numerous units throughout Afghanistan.o Processing 100+ weekly supply transactions for class VIII through DMLSS, including controlled substances and temperature sensitive vaccines. o Maintaining and operating military 10k and 5k forklifts and 5-ton trucks.

Washington, D.C., Us

Biological science technician supporting aquatic ecology and wilderness projects through lab and field work; requiring meticulous data collection, adhering to strict protocol, assisting in the preparation of technical reports, and managing/entering critical data.Specific accomplishments include:o Planning daily activities, coordinating logistical support, and managing administrative and laboratory needs.o Analyzing and preserving samples collected from the field using proper analytical chemistry and biological lab techniques. o Installing, operating, and maintaining aquatic monitoring equipment and overseeing the maintenance and care of laboratory equipment and inventory. o Using Microsoft Excel, Word, PowerPoint, and Access to compile, store, retrieve, analyze, and report data.o Deploying technical project equipment to collect water quality data (DO, water temperature, pH, TDS, etc.) and following strict protocol to gather chlorophyll-a, zooplankton, and macroinvertebrates samples.

Washington, D.C., Us

Supervising and managing warehouse functions pertaining to the receipt, storage, distribution, and assembly of telescopes and their components. In addition, instituting quality control procedures for high grade optical lens polishing, component machining, and telescope manufacturing.Specific accomplishments include:o Consistently tracking overall operations in receiving and distributing telescopes and parts for companies throughout the U.S. and Germany.o Achieving warehouse savings goals by negotiating with overseas suppliers and implementing “in house” custom machining procedures.o Regularly providing on the job training as well as direct supervision and safety awareness guidance for employees.o Managing receipt documents and accountability records for all shipments and inventory.