Jason Slye

• Responsible for implementation of a new QC lab in Waltham
• Established QC strategy including the organizational structure and hiring plan
• Coach and develop a staff of 5 Directors/Analysts
• Manage routine testing of raw materials, in-process, drug substance, final product and stability study samples for clinical phase combination drug/device products at both internal and external QC labs
• Oversight of Environmental Monitoring, sample management and stability management
• Ensure that QC procedures, practices and analytical methods are in compliance with the applicable compendial, regulatory and customer requirements
• Coordinate with Analytical Development on the method transfers from the CTLs to the new QC lab
• Responsible for records associated with Quality Control testing including but not limited to leading and managing QC investigations OOT/OOS), change controls, CAPAs, and ensure investigations are thoroughly conducted
• Responsible for writing and reviewing the Module 3 sections for INDs related to stability, product testing

*Also held the role of Executive Director, Product Quality

• Managed routine testing of in-process, raw materials, drug substance, final product and stability study samples for clinical and commercial phase microbiome products
• Coached and developed a staff of 30 Director to Analyst level staff and contractors
• Established a QC center of excellence to perform release and stability testing for first oral microbiome commercial product
• Ensured that QC procedures, practices and analytical methods are in compliance with the applicable compendial, regulatory and customer requirements
• Led the Analytical Sciences & Technology function responsible for test method introduction/qualification/validation and instrument qualification/validation both internally and externally
• Led the Stability function responsible for performing statistical analysis of QC data including assay trending, generation of stability protocols and reports and execution of stability scheduling/pulls
• Led the Product Quality Management (PQM) function responsible for the holistic view of product quality from Toxicology throughout the clinical phases and into commercial lifecycle maintenance
• Led the Technical Services function responsible for sample management, contamination control, LIMS implementation, and system administration of non-networked laboratory systems
• Chaired the specification review committee (SRC)
• Authored and reviewed the Module 3 sections for INDs and BLA related to stability, product testing and manufacturing

*Also held the role of Director, Product Quality & External QC

• Established the initial Quality Control function (QC center of excellence) including setting the QC strategy and hiring plan
• Coached and developed a staff of 5 Associate Director to Analyst level staff and contractors
• Established global standards related to raw material oversight, test method introduction/qualification/validation and stability for clinical cell and gene therapy products
• Transitioned to lead the Global Quality Control function responsible for stability, external testing laboratory oversight and method qualifications after NC site was established
• Led the Product Quality Management (PQM) function responsible for the holistic view of product quality from Toxicology throughout the clinical phases and into commercial lifecycle maintenance
• Led the GLP and GVP compliance encompassing research and pharmacovigliance activities
• Authored and reviewed the Module 3 sections for INDs related to stability, product testing and manufacturing.

• Partnered with the 29 Biogen affiliate offices to manage quality issues and process improvement opportunities to ensure Product Quality and clinical trial adherence
• Coached and developed a staff of 8 Managers/Specialists and contractors based in the US and Europe
• Managed Global Safety and Regulatory Sciences (GSRS) compliance and CAPA activities including KPI/KQI/metric development and trending to ensure Product Quality and clinical trial adherence
• Managed Quality oversight of Pharmacovigilance Safety Master File (PSMF), Global Case Management, Safety Data Exchange/Pharmacovigilance Agreements (SDEA/PVAs) and Individual Case Safety Reports (ICSR)

*Also held the following roles through internal promotions:

Associate Director, QC

Manager, QC

Sr Quality Project Manager

• Managed the internal and external business network strategy for the Quality Laboratories across Shire
• Managed the core Quality business processes and business optimization on a network wide level (13 internal labs, 32 external labs/CMOs) that ranged from various modalities including biologics, gene therapy and plasma
• Coached and developed a staff of 30 Associate Director to Specialist level staff and contractors based in the US and Europe
• Implemented new analytical testing technology: Reduced Identity testing TAT from 3 days to 2 hours and reduced testing costs by $250k annually
• Served as the consolidated capital holder for all of Quality, ranging from $10M to $50M
• Developed network-based strategy for a holistic and efficient method for QC testing (who, where & what) both internally and externally
• Managed raw material testing and release as well as raw material inspection and sampling for GMP warehouse operations (components/intermediates)
• Quality Lead on design/ build for facility startup activities related to labs and warehousing including infrastructure changes for labs and facility renovations (California, Massachusetts, Ireland, Austria, Argentina)
• Quality Operational Efficiency (OE) point of contact to implement key OE principles and initiatives across Quality, including KPI/metrics harmonization, trending and optimization across the network, Lean Labs, Lab Supplies Stockroom implementation and implementation of vendor managed inventory (VMI)

*Also held the following roles through internal promotions:

Supervisor II, QC

Supervisor I, QC

Scientist II, QC

Scientist I, QC

• Managed the Quality Control Laboratory Systems group in support of LabWare LIMS system support and implementation
• Managed the Operational Efficiency (OE) group to lead the implementation of Lean Laboratory principles/design
• Coached and developed a staff of 10 specialists
• Managed and trended the department KPIs/metrics and headcount and applied OE principles to workflow
• Initiated projects targeted at cost savings and enhanced compliance within Quality Control
• Created ways to enhance laboratory processes in order to move to a completely paper less system
• Performed routine Quality Control testing of in-process, bulk Drug Substance, final Drug Product and stability of clinical and commercial phase vaccines and biologics
• Performed method transfer to and from external companies (GSK, Genentech)