Michael Czerwonka Iv Email & Phone Number

● Led project group and change control for successful right first time execution of Process Performance Qualification Studies. Coordinated timely execution of multiple tasks utilizing MS Project from functional groups including Operations, Technical Operations and Quality. Authored and facilitated execution of multiple technical documents including PPQ protocol and report.● Led multiple change control and project teams for equipment improvements and required supply updates to support ongoing business needs across multiple IPT areas.

West Point

● Executed experiments for the development of a novel scale down laboratory process reflective of the manufacturing process for a polysaccharide conjugate vaccine. Unit operations included tangential flow filtration, centrifugation and sterile filtration.● Led, executed and trained employees on experiments supporting a novel sample preparation procedure. Unit operations included centrifugation and spin filter separation.

West Point, Pa

● Provided real time technical GMP support to the manufacturing floor including process troubleshooting of filtration skids and centrifugation systems, coordinating path forward with multiple groups and contemporaneous documentation coaching to ensure safe and compliant solutions.● Authored and executed numerous GMP and experimental protocols to troubleshoot manufacturing scale skids, provide deviation management support and drive CAPA implementation.● Provided SME technical support for routine quality and process hazard risk assessments, local procedures and batch records.● Supported critical lab investigation; quickly upskilled on new laboratory unit operations including but not limited to homogenization, TFF, silica chromatography via GE AKTA system, WES and BCA.● Managed and coached interns through projects contributing to business needs. Help included GMP technical protocol writing/approvals, connection with appropriate SME knowledge and execution support as needed.● Designed PI Processbook visualizations for proactive detection of potential process deviations, process support, troubleshooting and improvement.● Created various tools for location and quick retrieval of process historical documents and data. Tools improved potential deviation reaction time and batch record review cycle time.

West Point, Pennsylvania

• Successfully integrated and led unit operations to support transition of a polysaccharide based vaccine process. Unit operations included continuous centrifugation, depth filtration, tangential flow filtration, trituration and phenol and alcohol precipitations.• Successfully integrated with partner manufacturing groups as part of a project acceleration team. Responsibilities included on the floor support of water batch/document shakedown activities and project management support for consumables. • Co-led a design, execution and troubleshooting of a depth filtration DOE for downstream process development of a BSL2 live virus vaccine candidate in support of range finding process performance qualification. A range justification memo was authored for technical support.• Successfully designed, operated and improved a single use, closed system, sterile environment depth filtration skid for processing in a BSL2 environment.• Developed and co-authored a lab scale batch records for depth filtration unit operation and stock seed centrifugation on the Unifuge system. • Supported design and integration of single use components in manufacturing scale depth filtration and TFF skids.• Co-Led the upskilling of colleagues on depth filtration and TFF manufacturing scale skids for future BSL2 manufacturing.• Upskilled and independently executed other downstream unit operations in support of manufacturing investigations which includes AEX/MMC Chromatography and Sonication.

Gwynedd Valley

• Care for student's emotional and mental needs by providing support and encouragement

• Performed a variety of membrane filtrations efficiently and accurately• Identified and fixed 4 membrane filter dispensing units saving the company approximately $4,000• Successfully learned and utilized LIMS computer tracking system to log daily experiments

Chestnut Hill College

• Utilized Bioinformatic approaches to analyze and interpret gene expression data from microarray assays• Performed Q-PCR to verify results from microarray assay• Presented Bioinformatic and Q-PCR data at 2014 SEPCHE Honors Conference

Bachelor Of Science (B.S.), Biology

Double Minors in Chemistry and Mathematics

Archdiocesan Scholar

Education record