Jacob Schwab Email & Phone Number

Rockville, Maryland, United States

Rockville, Maryland, United States

Research Triangle Park, NC

• Nutrition and dietary supplements manufacturing company focused on the development of personalized pill-free formulations using custom automated technology. Cloud-based software is used to generate formulas that are.
• Planned and executed production runs across two facilities in two states (NC and VA) and managed a team of 3 full-time production operators
• Managed all procurement and production orders using Microsoft Dynamics-based ERP system
• Developed and implemented sample product program for potential commercial clients and investors

Research Triangle Park, NC

• Oversaw implementation of electronic Quality Management System to bring document management program into cGMP compliance
• Implemented maintenance and calibration program for critical production and facilities-related equipment and instrumentation at two facilities, each with 15+ pieces of equipment

Research Triangle Park, NC

• Reduced equipment and process validation lead time from 6-8 months to 4-6 weeks
• Key liaison with QA team to develop Batch Production Records that comply with FDA regulations
• Led analysis of machines to quantify operational performance and troubleshoot production problems

Research Triangle Park, NC

• Designed, assembled, tested, and validated first-generation automated compounding machine system
• Led testing of microwave-based pasteurization and packaging equipment to determine cross-product system settings for a repeatable hot-fill pasteurization production process
• Developed, documented, and maintained training program for team of 5 equipment operators
• Created requirements documentation for cGMP equipment and processes
• Developed and executed validation and verification protocols, including FATs, SATs, and IOPQs
• Instrumental in the physical and regulatory standup of two FDA regulated manufacturing facilities

Research Triangle Park, NC

• Designed and validated thermal model for water bath terminal pasteurization process that complies with FDA regulations
• Designed, tested, and documented subassemblies for prototype compounding machine

Research Triangle Park, NC

Research Triangle Park, NC

• Generated machine parts drawings and assemblies using SolidWorks for benchtop test units
• Designed and tested automated dosing mechanism for dispensing proprietary gel-based product

Research Triangle Park, NC

• Generated machine parts drawings and assemblies using SolidWorks for benchtop test units
• Developed animations demonstrating concept machine functionality using SolidWorks for investor pitches

Raleigh-Durham, North Carolina Area

UNC - Chapel Hill

Research Triangle Park, NC