Michael Cawley Email and Phone Number

• Build, manage and maintain strong working relationships with partners across Alnylam’s supply chain for key contract manufacturers of API and DP, for both clinical and commercial activities.• Direct representative between external CMO and internal teams through a proposed Governance Structure• Support demand and operational planning activities, forecasts, inventory, and production scheduling.• Manage the document review and approval process for the production of pre-clinical, clinical and commercial drug products.• Assist in scheduling transfer of process to support production of drug substance/drug product.• Track all current, projected and future activities and timelines related to raw materials, API production and drug product production• Generate project timelines, build Gantt charts, and identify deliverables using Microsoft Project.• Maintain production tracker timeline, contract database, vendor scorecards, and invoice receipt tracking on department SharePoint website to ensure visibility across all functional groups.• Work closely with the procurement team on contract vendor selection, outsourcing models, and vendor evaluation audits, for external manufacturing and packaging partners. • Responsible for developing clinical and commercial manufacturing, service and supply agreements in close collaboration with procurement, external manufacturing and quality.• Lead or assists with manufacturing deviations, customer complaints and product failure investigations. • Support Supply Chain Product Teams to ensure the optimal supplier performance to achieve balance of cost, quality and customer service.• Track and present trending data for CMO KPIs to Alnylam Leadership Team.• Develop, communicate, & monitor relevant supplier compliance metrics.• Help organize and lead Quarterly Business Reviews with Tier 1 CMOs.

• Responsible for the manufacturing of immunoassays used by Centaur and CP instrumentation within a cGMP regulated environment• Coordinate and execute investigations and implement corrective and preventive actions (CAPAs)• Develop, update, and revise Standard Operating Procedures (SOPs) and execute | review document changes• Conduct Risk Assessments and document results for Quality purposes• Create and participate in the Design of Experiments (DOE)• Participate in Quality Control cross-training to gain interdepartmental knowledge• Completing manufacturing support studies and processes• Coordinate and perform material and process validations following written protocols• Maintained a 95% batch record accuracy throughout audit processes• Gather and record production data in order to reduce cycle-time and recommend improvements• Resolve complex manufacturing or chemistry related problems affecting daily operations• Operate various instrumentation such as MLA Spectrometer for Chemiluminescence, Spectrophotometer, and UV-VIS Spectrometer• Work with Biochemists for reagent production support, troubleshooting and root cause analysis• Responsible for observing Technicians in the laboratory to prevent operator errors• Completed Project Management Fundamentals coursework through Velociteach trainings• Maintained a 95% On-Time Completion metric

• Perform metals sample preparation using manual, automated or instrumental methods in accordance with applicable standard operating procedures and ensure appropriate testing procedures are conducted in compliance with QA.• Chemically prepare soil, water, and oil samples for metals analysis by FTIR liquid spectroscopy through the process of TCLP, SPLP, and aqueous microwave assisted acid digestion.• Prepare reagents and standards as needed.• Communicate with analysts and managers to meet turn-around-time goals by prioritizing samples and/or clients.• Develop improved techniques with Lab Coordinator, Team Leader or Manager.• Metals Department "On Time Performance" for the 2013 year was 95% - an increase of 8% from the previous fiscal year.