Jacob Johanni Email & Phone Number

Denver, Co, Us

• 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• Supported the Inventory and Manufacturing group in the launch of a gene therapy product including conducting risk assessments, RACI analyses, creating process maps, and reviewing a standard cost model for accuracy

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. • Produced weekly status reports to track the status on-going projects and essential deliverables for site leadership team.• Created risk tracking tools to highlight high risk items and track risk de-escalation through project closure.

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