Derek Sorel Email & Phone Number

Cambridge, MA

• Lead the Alnylam QC Group for quality control testing under cGMP at two Alnylam manufacturing sites (Alewife/Norton)
• Oversee Alnylam QC staff in performance and metrics of QC testing activities for API, drug product, raw materials, excipients and environmental testing. Understand and can interpret all relevant laboratory techniques
• Establish schedules and fully proficient in laboratory data systems.
• Support budgeting and design of new laboratory facilities
• Assure continued cGMP compliant state of Alnylam QC testing laboratories
• Oversee timely transfer and validation activities for QC testing methods at Alnylam Alewife manufacturing site

Cambridge, MA

• Maintain Reference Standard Program appropriate for clinical and commercial stage and assures continued GMP compliant state of Alnylam Reference Standard Program.
• Perform in-house characterization and stability testing of early phase reference standards and oversee reference standard testing at contract research organizations.
• Analyze and trend data within the context of stability expectations and specifications for the respective reference standards.
• Author and reviews reference standard characterization reports, protocols and reports. Extend re-test dates for reference standards.
• Contribute data to characterization, analytical and stability sections of regulatory submissions and responds to agency requests on these sections.
• Contribute to investigations of stability Out of Trend (OOT) or Out of Specification (OOS) investigations.

• Extensive experience performing and reviewing OOS/OOT investigations in the Trackwise system
• Experience in performing and reviewing deviations and CAPA
• Experience performing and reviewing Change Control
• Experience conducting regulatory audits with FDA, EMEA, TGA, and MHRA
• Experience with qualification and re-qualification of Primary and Working Reference Standards
• Create and revise SOP’s for assays and laboratory procedures

Bachelor Of Science (Bs), Biochemistry, Summa Cum Laude

Education record