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• Oversee investigations of anomalous/ atypical, Out of Trend (OOT), or Out of Specification (OOS) results related to Alnylam QC• Oversee timely closure of investigations, exceptions, corrective actions and change controls related to QC testing at Alnylam manufacturing sites• Author quality sections of regulatory submissions and respond to agency requests on these sections as they relate to QC testing• Assure sound statistical trending of batch release and assay control data at Alnylam Alewife site• Exhibit excellent leadership and teamwork skills• Excellent communication and presentation skills to engage in CMC discussions and represent the Alnylam QC laboratories during Regulatory Agency inspections

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.• Statistically interpret stability data.• Author and review of method transfer and method validation protocols and reports ensuring compliance with regulatory expectations • Participate in technology transfer with contract testing organizations and contract manufacturing organizations to support product manufacture and testing at multiple organizations.• Procurement and installation of new instrumentation, including IQ/OQ/PQ oversight.• Conduct audits of outside vendors to ensure compliance of storage and analysis of reference materials.

• 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• Effectively manage a weekend shift of approximately 15 personnel over a 24 hour period (Fri-Mon)• Create and maintain a working schedule for the lab

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

Education record