Jeffery Moore Email and Phone Number

• Provide innovative and strategic leadership for the Facilities and Engineering teams • Develop and drive site capital projects, site operations projects, and site maintenance to enable operations and other support functions to meet business expectations in cost, quality, compliance and safety• Effectively manage department budget of approximately $18 million with additional $4-6 million in CapEx projects • Organize the Engineering team to support the expected growth and work closely with the HR team to attract top talent to fill key roles in the new organization. • Support all aspects of inspection readiness including regulatory interaction/response

• Developed all aspects of the Manufacturing department, including Operations, Support and Compliance, to support viral vector manufacturing for Phase III/Commercial operations • Built a team of over 100 employees i• Managed multiple teams of leaders and associates across multiple client programs and shifts from suite start up to routine operations.• Oversaw all day to day Manufacturing operations and worked closely with the production staff to troubleshoot process and equipment issues, while ensuring appropriate and proactive client and internal stakeholder communication• Worked closely with Engineering teams in the design and build out of manufacturing space as site project sponsor and end user• Supported and contributed to the site strategy on PLI/PAI readiness

• Accountable person for Sanofi during project development and implementation • Design review, At scale and scale up development ,Tech transfer, Facility start-up, Engineering runs, Process Validation, Regulatory Approval, Operations• Enables single-use technology transformation• Collaborates cross-functionally with Process Science, MSAT, Engineering, Validation to support design, operation, and strategic project direction• Support implementation 50L CZ process and pilot plant expansion for scaling up to 500L

• Responsible for an organization of 120+ FTE’s (5 Sr. Managers, 24 supervisors)• 2 Media preparation suites, 2 Cell Culture Suites, 3 Harvest Capture suites, Small Scale, 2 Equipment Preparation areas and a Specialist team• Area owner for 3 capital expansion projects (Media, Harvest Clarification Capture, Clean Equipment Preparation)• Designed operational readiness for expansion projects • Develop critical issues playbook used throughout the site to solve complex multi-function issues• Complete work plan as related to Consent Decree numbered steps• Remediated/Qualified 6 bioreactor trains

• Responsible for the safety and operations of large scale/small scale cell culture, upstream compliance/ training and equipment preparation• Develop CAPA tracking and performance metrics to achieve 100% on time completion, 65% improvement• Develop deviation tracking, assignment and performance metric to deliver 50% improvement with on-time completion• Recognized by Global Safety for developing best practice in terms of investigating and improving safety • Challenge staff to improve upon metrics and continuously improve personal skill sets• Manage and develop the performance of 50+ direct/indirect reports by setting clear goals, providing timely performance feedback, recognizing and rewarding high achievers and holding reports accountable • Respectfully challenge business as usual, staff and peers to perform at the next level.• Champion/ owner of MDI (Managing for Daily Improvement) cross functional board that tracks KPIs and metrics as they relate to Site goals.• Member of EMT (Extended Management Team), EAC (Environment Action Committee), HSE (Health, Safety and Environment) committee

Sr. Manager, Manufacturing Services• Responsible for implementing, expanding and managing Manufacturing Services. • Selected as a Change Agent to partner with McKinsey & Company to drive cultural change and process improvements within Manufacturing and Supply chain. • Developed standardized work packages and enhanced performance dialogs. • Defined and continuously refine functional group KPIs.• Partner with Supply Chain to manage transformation activities and Champion SAP integration for Mfg.• Member of the site ELT (Extended Leadership Team) reporting to the Executive Director of Manufacturing.• Master plan design Champion for Manufacturing, ie workspace/storage design, Business Continuity.• Implemented a structured problem solving approach.• Collaborate/influence peer management team and supporting functions (i.e.,QA,HR,PD) to achieve department goals.• Perform NPI activities from facility fit evaluations to change over cleaning strategy.• Execute and/or approve test protocols for processes and cleaning validation. • Evaluated/developed small parts/process hoses automated cleaning strategy to improve efficiency. • Project manager for the COP bath Validation team.• Developed soiled/clean parts accumulation and flow strategies. • Optimized the raw material management process.• Developed Buffer prep dispensing strategy. • Coached and developed diverse empowered teams.• Developed a high performing team, of 21 members• Champion of the Mfg safety program.

See Boehringer-Ingelheim experience. Amgen, Fremont was acquired by Boehringer-Ingelheim March 2011.

• Shift manager for 5-8 staff members in Upstream manufacturing.• Managed/troubleshot the operations of the Upstream manufacturing equipment consisting of 30L, 100L, 400L, 2K, 12K bioreactors, Harvest Tanks and filter carts, Media tanks, Centrifuges, CIP skids, SIP systems and miscellaneous bench top and infrastructure equipment. • Identified areas for staff improvement and scheduled/launched learning groups in these areas to develop staff skill sets in manufacturing. • Involved key stake holders on important decisions to generate the best path forward.• Drove/developed/matured process improvement initiatives such as audit readiness and learning groups.• Held self and team accountable for delivering high quality results.• Coordinated manufacturing personnel for on-site expansion project, including activities such as commissioning and validation. • Maintained audit-ready conditions on the manufacturing floor at all times.• Reviewed production records for completeness and accuracy. • Utilized lean methodologies in manufacturing.• Develop cross site relationships to share best practices• Supported audit inspections for international and domestic agencies and partners• Supported training exercise for FDA new recruits • Daily systems used: LMS, EDMQ, Delta V, INCA, BPDI, TrackWise/QMTS, Maximo, MES, SAP, MicroSoft Office, Sharepoint

• Organized, scheduled and lead new equipment commissioning and validation test runs from vial rinsing through capping/tray loading.• Manufacturing Lead Specialist on ALUS (automated loading and unloading system), Bio-Set and aluminum cappers and tray loader.• Co-developed product filled vial tray transportation carts for safe delivery to inspection/packaging and storage. • Responsible SME (subject matter expert) for the development of filling/freeze drying/capping/vial reconciliation SOP’s/BPRs.• Mentored and qualified 6 personnel to perform PQ test runs.• Developed equipment change over installation procedures utilizing smoke studies and novel autoclave wrap approach.• Developed ISO5 intervention methodologies. • Set and developed goals for production specialists and coached group on conflict resolution.• Communicated with vendors on installations, automation, repairs and troubleshooting.• Worked with suppliers to deliver “right sized” components to maximize operator efficiency.• Communication link to production Sr. Management on engineering activities and project status.• Coordinated successful launch of safety programs in the new facility involving safety protocol generation, effective training and promoting active participation.

(Lead) Sr. Production Technician, Fermentation Manufacturing • On-the-floor lead of operations and troubleshooting of mammalian Fermentation and Ultra Filtration.• Drove 6S teams in the organization of production areas, equipment and supplies.• Assisted Sr. Management in managing work load prioritization, including operator scheduling, maintenance, instrumentation, engineering scheduling and equipment performance testing.• Contributed to corrective action recommendations for the elimination of process anomalies.• Premier Circle Award recipient for excellence in 2003.