Jason Slye

About Jason Slye

Highly accomplished and seasoned leader in Quality and Operations within the…

Experience

1. Executive Director, Quality Control

   Vericel® Corporation

   Aug 2024 — Present · Cambridge, MA, US

   Manage Environmental Monitoring and routine testing of raw materials, in-process, drug substance, final product and stability study samples for commercial phase cell therapy/medical device products (MACI & Epicel) at the internal QC lab.• Lead the implementation of a new QC lab in Burlington, spearheading the EMPQ, QC strategy (the organizational structure and the hiring plan) and contamination control strategy.• Coach and develop a staff of 25.• Establish core QMS elements and systems for internal testing and manufacturing at new QC lab in Burlington.• Manage records associated with Quality Control testing including but not limited to QC investigations OOT/OOS), change controls, CAPAs, and ensured investigations were thoroughly conducted.• Coordinate with Research & Development on method qualification/validation and the method transfers from the QC lab in Cambridge to the new QC lab.• Write and review Module 3 sections for IND related to stability, product testing, and manufacturing.

Education

• Northeastern University

  Master of Business Administration (M.B.A.), Supply Chain Management

  2015 — 2019

• Northeastern University

  Master's, Regulatory Affairs

  2006 — 2008

• Merrimack College

  Bachelor's of Science, Health Science

  1997 — 2001

Skills

• Change Control
• Metrics
• Six Sigma
• Gxp
• Aseptic Processing
• Elisa
• Quality Control
• Gmp
• Quality System
• Quality Systems
• V&V
• Computer System Validation
• Analytical Chemistry
• Hplc
• Access
• Minitab
• Qc
• Sap
• Biotechnology
• Pharmaceutical Industry
• Sop
• Fda
• Cgmp
• Glp
• Usp
• Quality Assurance
• Trackwise
• Sds-Page
• Chromatography
• Sql
• Visio
• Ind
• Capa
• Lims
• Continuous Improvement
• 5s
• Microsoft Word
• Powerpoint
• Microsoft Excel
• Technology Transfer