Developed and implemented a Quality Management System and maintaining Quality Management for the company.

Consulting for the Biotechnology and Facilities Engineering industries

Led a staff of 6 to 20 facility and operation managers and staff supporting 50 – 200 employees, and managing a $3M - $5M operating budget. Managed all Rockville site operations and the QA department maintaining quality systems and compliance.• Led company’s QA department providing oversight for all clinical, manufacturing and finishing operations for commercial vaccine production at CMOs.• Led Quality Audit Team for both on site and questionnaire audits, maintaining all documentation… Show more Led a staff of 6 to 20 facility and operation managers and staff supporting 50 – 200 employees, and managing a $3M - $5M operating budget. Managed all Rockville site operations and the QA department maintaining quality systems and compliance.• Led company’s QA department providing oversight for all clinical, manufacturing and finishing operations for commercial vaccine production at CMOs.• Led Quality Audit Team for both on site and questionnaire audits, maintaining all documentation with Document Control.• Led search team for a new R&D corporate headquarters resulting in the lease signing of a new 100,000+ square foot building and the planning of $22M build-out.• Identified CMOs for commercial vaccine production and provided oversight for manufacturing operations.• Managed EHS Department, maintaining site compliance and permitting. Show less

Managed a team that oversaw all facility and operation site functions including Operations, Administration, Materials Management, Facilities Engineering and Clinical Supplies Production.• Led a corporate wide search project for a new 100,000 sq. ft. R&D and clinical manufacturing facility in Northern Virginia and Maryland, negotiating a final lease agreement in Maryland and securing funding from State and County for the build out.• Managed all lease negotiations (3 leases inclusive of 5… Show more Managed a team that oversaw all facility and operation site functions including Operations, Administration, Materials Management, Facilities Engineering and Clinical Supplies Production.• Led a corporate wide search project for a new 100,000 sq. ft. R&D and clinical manufacturing facility in Northern Virginia and Maryland, negotiating a final lease agreement in Maryland and securing funding from State and County for the build out.• Managed all lease negotiations (3 leases inclusive of 5 buildings).• Directed QC department to support production operations and clinical operations for clinical studies.• Managed Facilities department supporting all site operations. Show less

Managed staff of operators and contractors to produce clinical materials, as well as site facilities staff.• Implemented a CMMS system reducing semi-annual shutdowns from 4 weeks to 2-3 weeks and on-hand part replacements for Pilot Plant resulting in >10% budget savings.• Managed generation of all Facilities SOPs for all Plant related equipment and fermentation research equipment.• Produced clinical materials for Phase III clinical studies.

Managed staff and contractors to complete construction, validate, commission and operate company’s first clinical manufacturing facility under Univax Biologics.• Led a team that generated and implemented SOPs for all mechanical and upstream equipment for Pilot Plant.• Designed and managed renovation of a fermentation development lab and procured all associated equipment for scale-up studies.• Performed all scheduling for both upstream and downstream processes inclusive of… Show more Managed staff and contractors to complete construction, validate, commission and operate company’s first clinical manufacturing facility under Univax Biologics.• Led a team that generated and implemented SOPs for all mechanical and upstream equipment for Pilot Plant.• Designed and managed renovation of a fermentation development lab and procured all associated equipment for scale-up studies.• Performed all scheduling for both upstream and downstream processes inclusive of semi-annual shutdowns.• Provided cGMP materials research and manufacturing needs for all pipeline products.• Maintained operations at least 10% below budget. Show less

Fermentation Development and Production for research grade restriction enzymes, RNA/DNA products, Competent Cells.

• Established an internal cell qualification program prior to downstream processing resulting in a higher quality products with >25% increase in final yields.• Coordinated all production scheduling with a newly established Materials Management department that eliminated backorders for all products.• Established and coordinated an internal cross-training program.• Defined, generated and implemented all SOPs in fermentation area.• Scheduled shift crews and assigned manpower to… Show more • Established an internal cell qualification program prior to downstream processing resulting in a higher quality products with >25% increase in final yields.• Coordinated all production scheduling with a newly established Materials Management department that eliminated backorders for all products.• Established and coordinated an internal cross-training program.• Defined, generated and implemented all SOPs in fermentation area.• Scheduled shift crews and assigned manpower to Plant Recovery and Maintenance areas and provided production schedules to all other support groups. Show less