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 both internal and external QC labs.• 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.• Wrote and reviewed Module 3 sections for IND related to stability, product testing, and manufacturing.

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.• Led various Quality functions including Analytical Sciences & Technology, Stability, and Product Quality Management.• Coordinated with Analytical Development on method qualification/validation and the method transfers from the CTLs to the new QC lab.• Chaired the specification review committee and responsible for establishing a QC center of excellence for release and stability testing.• Wrote and reviewed Module 3 sections for INDs and BLA related to stability, product 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 Operating Procedures and established a QC center of excellence for release and stability testing (Cambridge, MA).• Managed method development, method qualification/validation and method verification at CTLs.• Managed Product Quality Management function ensuring quality throughout the product lifecycle.• Established core QMS elements and systems for internal testing and manufacturing.• Oversaw GLP, GVP, and aspects of GMP compliance for product development.• Primary Quality Control representation for laboratory/facility design and build of NC manufacturing plant.• Wrote and reviewed Module 3 sections for INDs related to stability, product testing, and manufacturing.

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®, Firazyr®, Flexbumin®, Gammagard®, Natpara®, Recombinate®, VPRIV®).• 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).• Primary Quality Control representation for laboratory/facility design and build projects globally (California, Massachusetts, Ireland, Austria, Argentina).• Served as the consolidated capital holder for all Quality projects (up to $50M).

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®, Premarin®, Prevnar13, ReFacto®).

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