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.
• 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.
• 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.
• 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.

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.
• 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.
• 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.
• 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.

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