Brian Patti Email & Phone Number

Collegeville, PA, US

United States

- Manage various regulatory outsourced operations across two external partners- Manage Vaccine/Pharm global regulatory filings (IND/CTA, BLA/NDA, Regulatory Response, Annual Reporting, ect.)- Responsible for Developing and Leading Quality Assurance and Business Process Improvement within Regulatory Operations. - Responsible for Resource and Demand Capacity.

- Develop and installed a Quality Assurance Position/Group within Global Marketing Operations- Created and Deployed Quality Systems, including an Internal Auditing and Deviation Management Program- Deliver value by assembling and managing cross functional teams aimed at continuous improvement and optimization of the creation, approval and delivery of.

• Start-Up Operations Lead for a 7200sqft Sterile Supply Production Area supporting 4 Vaccine Product franchises- Managed a team of employees (salary and hourly) to support facility operation throughout validation and.
• Business Process Lead for Bulk Vaccine Vessel Program- Manage a team responsible for tracking, testing and data traceability for ~14,000 bulk vessels in circulation.- Stabilized the business through weekly workflow.

- Piloted and established a new Reliability Engineering role within the Engineering, Maintenance and Utilities organization- Manage Business Process and Technical Improvements for Qualified Utilities Infrastructure- Primary contact for Critical Utility Regulatory Agency support (FDA, EMEA, etc.)- Cross Functional Team Leader

- Capital Project Engineer supporting $6.0 MM of Pharm Operation and $3.4MM of Site Infrastructure renovation, including of two High Shear Granulation Suites, the Glatt Column Filter Washer/Dryer Installation, Oxidizer Replacement and Chemstock Dispensing Booth - Managed System Qualification (System Life Cycle Documentation, Change Control, IQ/OQ/PQ) of.

Education record

Mba, Mba

Bs, Mechanical Engineering