Jacob Johanni Email & Phone Number

• Conducted investigations for Major deviations identified during the production of commercial gene therapies at a CMO
• Developed CAPAs with input from site leadership to prevent recurring issues identified during Major deviations
• Managed internal resources and client feedback to deliver a QMS library to a biopharmaceutical company
• Developed a clinical regulatory guidance matrix to compare standards by product phase, product type, and QMS elements across 5 regulatory bodies
• Conducted cGMP mock audits for clients with upcoming FDA inspections
• Generated supplier audit forms for API manufacturers, drug substance, drug product, QC labs, and warehouse and logistic suppliers, as well as data integrity inspections

King Of Prussia

• Performed remote supplier assessment, including procedure and quality metric review, and virtual inspections of site QC lab, manufacturing suite and warehouse
• Assisted in the development of a supplier site risk assessment rubric.
• Created a Python script to facilitate FDA audit metric retrieval and consolidation and executed over 300 risk assessments.
• Developed a database to capture manufacturing data, trend ongoing run data in real time, store historical data in a tabulated table, and analyze historical run data.
• Facilitated, coordinated, and drove internal and client meetings ensuring alignment and timeliness delivery of key project tasks.
• Tracked site quality PAI readiness deliverables, including follow up with action owners.

Eastlake, Ohio

• Assisted the process engineering team in designing and implementing cost saving solutions in the production of composite pressure vessels and carbon filtration blocks.
• Aided in the creation and R&D of new lead reduction carbon block formulas.
• Collaborated with the quality engineering team to create quality specification for R&D carbon blocks.

Bachelor Of Science - Bs, Chemical Engineering

Minor in Chemistry

High School, Diploma With Honors