Jason Slye Email & Phone Number

Cambridge, Massachusetts, United States

Waltham, Massachusetts, United States

• Company had a 75% reduction in staff in May 2024.Led the implementation of a new QC lab in Waltham, spearheading the QC strategy, the organizational structure and the hiring plan.
• Coached and developed a staff of 5 Directors/Analysts.
• Managed Environmental Monitoring and routine testing of raw materials, in-process, drug substance, final product and stability study samples for clinical phase combination drug/device products (LYR-210 & LYR-220) at.
• Established core QMS elements and systems for internal testing and manufacturing.
• Managed records associated with Quality Control testing including but not limited to QC investigations OOT/OOS), change controls, CAPAs, and ensured investigations were thoroughly conducted.
• Coordinated with Analytical Development on method qualification/validation and the method transfers from the CTLs to the new QC lab.

Waltham, Massachusetts, United States

• Also held the role of Executive Director, Product Quality
• Successfully managed Quality Control operations while also overseeing Product Quality for clinical and commercial microbiome products.
• Coached and developed a staff of 30 Director to Analyst level staff and contractors.
• Managed routine testing of in-process, final product, and stability study samples (VOWST™, SER-155, SER-301) ensuring compliance with Standard Operating Procedures.
• Oversaw internal QC laboratories and operations to ensure adherence to GxP’s and regulatory requirements.
• Established core QMS elements and systems for internal testing and manufacturing.

Cambridge, Massachusetts, United States

• Also held the role of Director, Product Quality & External QC
• Established QC strategy and organizational structure, driving efficiency and compliance for clinical cell and gene therapy products.
• Coached and developed a staff of 5 Associate Director to Analyst level staff and contractors.
• Led the Global Quality Control function that performed routine testing of intermediate product, final product, and stability study samples (BEAM-101, BEAM-102, BEAM-201, BEAM-301) ensuring compliance with Standard.
• Managed method development, method qualification/validation and method verification at CTLs.
• Managed Product Quality Management function ensuring quality throughout the product lifecycle.

Cambridge, MA

• Managed global quality standards and processes for affiliate offices, ensuring adherence to regulations.
• 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 related to Aducanumab, Tofersen, Lecanemab.
• Partnered with Biogen affiliate offices to manage quality issues and process improvement opportunities.
• Led audit and inspection readiness activities and evaluated Pharmacovigilance systems for compliance.

Lexington, Massachusetts

• Takeda acquired Shire on January 2019*Also held the following roles through internal promotions:Associate Director, QC; Manager, QC; Sr Quality Project Manager
• Spearheaded global standards for raw material oversight, method validation, and stability management.
• Coached and developed a staff of 30 Associate Director to Specialist level staff and contractors based in the US and Europe.
• Developed network-based strategy for QC testing efficiency across multiple locations (13 internal labs, 32 external labs/CMOs) for biologic, plasma and gene therapy products (Adynovate®, Vonvendi®, Cinryze®, Elaprase®.
• Coordinated with Analytical Development on method qualification/validation and the method transfers to and from internal sitesas well as to and from CTLs.
• Managed raw material testing and release as well as raw material inspection and sampling for GMP warehouse operations (components/intermediates).

Andover, MA

• Pfizer acquired Wyeth in 2009*Wyeth acquired Genetics Institue in 2003*Also held the following roles through internal promotions:Supervisor II, QC; Supervisor I, QC; Scientist II, QC; Scientist I, QC
• Led various Quality functions including Laboratory Systems andOperational Efficiency (OE).
• Coached and developed a staff of 10 specialists.
• Performed method transfers and routine Quality Control testing of in�process, bulk Drug Substance, final Drug Product and stability of clinical and commercial phase vaccines and biologics (Benefix®, Herceptin®.

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

Master'S, Regulatory Affairs

Activities and Societies: Sigma Epsilon Rho Honor Society

Bachelor'S Of Science, Health Science