Tracey Vogl Email & Phone Number

Glenview, Illinois, United States

Providing project management for custom bioprocess equipment projects. Creating and maintaining project schedules, tracking milestones, managing and communicating changes in scope and schedule with the customer, internal project engineers, and team members. Tracking budgets, facilitating meetings, and maintaining project documentation. Optimizing communication by improving and expanding utilization of project management tools.

Chicago, Il

Provided oversight and leadership in support of on-time delivery of biosimilar launch product. Developed and owned the Launch Plan and facilitated team meetings, generated status reports and dashboards, drove the team to complete deliverables on time. Built relationships with and influenced internal and external stakeholders.

Greater Chicago Area

Supervised contract manufacturing organizations for sterile injectable drug product manufacturing and packaging. Managed technology transfer, process validation, and production of two biosimilar products. Tracked project status, deliverables, and scope. Reviewed proposals, change orders, and managed budget. Resolved project issues, deviations, and investigations. Reviewed data, oversaw creation and cross-functional review of manufacturing documentation. Facilitated meetings and coordinated information flow between SMEs. Ensured proper material flow, sample and final product shipments. Managed work performed with contract laboratories for method validation, release and stability testing. Worked closely with Legal and Quality Assurance on manufacturing agreements and quality agreements. Reviewed Module 3 351(k) BLA documentation.

Greater Chicago Area

Led the cross-functional Core Team for the lead biosimilar product. Managed commissioning and qualification of an internal commercial fill finish and packaging facility. Developed and managed project plans, facilitated project and steering committee meetings, identified risks, escalated issues, and communicated project status to executive management through the use of custom dashboards. Led teams through risk analysis and change management. Ensured that investigational products were manufactured and supplied to non-clinical and clinical sites. Hand-selected by executive leaders to facilitate executive team meetings. Acted as a Host and a Scribe for regulatory inspections.

Chicago, Il

Provided project management for teams responsible for biosimilar drug development activities and design of proprietary innovative bioprocess technologies (sterile disposable bioreactors). Created and maintained project development plans, tracked team activities, and collaborated with functional areas to anticipate and identify project issues.

Managed drug development, investigational drug product manufacture, distribution and associated budgets for transdermal system. Managed network of international contract manufacturers, packagers, and laboratories. Created, reviewed, and approved specifications, test methods, stability protocols, batch records, validation protocols, and quality/manufacturing agreements. Documented deviations, investigations, and implemented CAPAs internally and at CMOs. Managed assay development, validation, release and stability testing. Maintained international supply chain. Prepared CMC sections of regulatory submissions (pre-IND, IND, 505(b)(2) NDA, eCTD), regulatory communications, and briefing packages. Authored development reports, generated and updated SOPs. Developed novel packaging, labeling, and customized shipper for clinical trial material. Served as the Lead for CMC during face-to-face meetings with FDA.

Supervised a team performing process development and production campaigns for upstream bioprocess operations to manufacture drug substance. Improved manufacturing capabilities by establishing a GMP compliant manufacturing suite (upstream and downstream). Ensured regulatory compliance with FDA regulations and ICH guidelines. Developed, reviewed, and approved product documentation: SOPs, specifications, test methods, and batch records. Expanded capabilities by leading process scale-up projects. Established an R&D upstream bioprocess laboratory: designed layout, selected equipment, and hired staff. Completed technology transfer of upstream processes to Pfizer.

Master Of Science - Ms, Regulatory Affairs And Quality Assurance

Ba, Biological Sciences