Daniel Booth Email & Phone Number

Gaithersburg, Maryland, United States

Gaithersburg, Maryland, United States

Global Biologics QualityCOVID Product Quality Represent Quality at CMC Teams and GST (Global Supply Team) as the "Voice of Quality"Act as liaison for the entire Quality functionEngage Quality stakeholders (e.g., Device Quality, Site Quality, Development Quality Biologics) to implement CMC Team strategies and elevate Quality constraintsProvide risk-based, data driven and phase appropriate Quality advice to CMC TeamReview regulatory filingsResponsible for Quality product-focused activities associated with technology transfersSupport clinical and commercial biologic pipeline products

Gaithersburg, Md

Voice of Quality on CMC Strategy Teams, responsible for a broad portfolio of molecules in varied novel modalities.

Gaithersburg, Md

Gaithersburg, Maryland

Assure the safety, integrity, strength, purity and quality of clinical phase I, II and III vaccinesPerform lot disposition of drug substanceReview and approve completed Batch Production Records for multiple product linesReview and approve Master Manufacturing Batch Records and SOP revisions for multiple product linesProvide on the floor support for multiple product lines across all stages of clinical development21 CFR Parts 210 and 211Trackwise • iLIMs • SharePoint • QUMAS EDMS • SAP • UNICORN • MODA • MFGPro • Microsoft Office • Microsoft Dynamics NAV

Framingham

Assure the safety, integrity, strength, purity and quality of biopharmaceuticals.Provide on the floor support for GMP manufacturing operations.Review GDP production documentation.