Anthony Deluca Email & Phone Number

Lawrence Township, Nj, Us

• Develop OPEX and Culture of Excellence methods to prioritize work projects, baseline desired value gains, and communicate changes• Implement Process Confirmation Activities to ensure sustained change and create opportunities for continuous improvements• Standardize Key Metrics to ensure Quality Outcomes as well as the ability to monitor performance and health for processes and systems • Support the ongoing development of Global Processes with close cooperation and input from relevant GXP functions• Develop and Implement Process monitoring methods, including data collections, KPIs, dashboards, metrics, and reporting mechanisms for Quality System initiatives and impacted compliance programs• Review, adjust and maintain governance to improve meeting standard work aligned to BMS leadership sessions

Rahway, New Jersey, Us

• Lead a team of 15 people responsible for the planning and execution of global supply chain moves supporting Phase 1-Phase 3 clinical manufacturing, Raw Material procurement receival and sampling supporting Pilot Plant Manufacturing, dispensing and subdivision for clinical manufacturing and development and stock room support across the Rahway site• Design, Implement and initiate open handling operations for 2 subdivision booths totaling 4,200 sq ft of controlled GMP space. Maintain staffed organization and developed SOPs to support day to day operations. • Define roles and responsibilities needed on a continuous basis during plant start and Enterprise system startup on site • Partner with customers across the globe to plan, define requirements and execute shipments supporting the clinical pipeline around the world • Optimize corporate policies and practices to define fit for purpose application of requirement for research and development • Establish standard work tools and perform After Action Reviews as necessary to develop an operation that is learning and continuously adapting to emerging needs ACHIEVEMENTS • Installed SAP for Procurement, Goods Receipt, Incoming Goods Sampling, and Material Subdivision • Established 15 SOPs and an additional 15 Standard Work Tools in support of subdivision group startup and operation• Established 3 local tier processes and scorecards to manage workflow, issues and escalations• Defined Requirements that supported on time material delivery for 15 non standard clinical supply chains including those associated with the Merck COVID vaccine and the Merck Therapeutic treatment • Achieved 95% on time delivery for over 500 shipments supporting over 70 research compounds• Reduced development cycle time for approximately 8 programs per year by optimizing corporate Import for Export requirements in research and development.• Saved over 450K in Import Duties and over 150K in compliance penalty avoidance

Rahway, New Jersey, Us

RESPONSIBILITIES • Lead and realized a corporate initiative designed to improve the establishment of non standard supply chains associated with the global movement of GMP development materials. • Partnered with Trade Compliance, Tax, Finance, Logistics, Supply Chain and Development Scientists to define and install a standardized model for defining Transportation Requirements, Financial Requirements, Global Trade Requirements, and Regulatory Requirements for the nonstandard movements defined above. • Routinely Managed material moves with various Global Sites and Contract Manufacturers across North America, the European Union/ Switzerland, and Asia-Pacific Regions• Ensured development materials entering and residing the in the USA adhered to all global trade requirements • Lead a team of 3 Individuals that supported the above installed strategies with transactional order support as needed• Supported the closure of a site in the UK, and relocation of over 200 materials to sites in Switzerland/ CMOACHIEVEMENTS • De-Risked over 270 non standard movements of development materials across Phase I-IV milestones of development • Authored and Installed over 10 novel business processes across multiple sites in the development network to ensure the on time delivery of goods across the globe• Maintained compliance of transported items into the USA against Global Trade obligations, avoiding corporate penalties and fines of over 2.5 million dollars • Implemented a process for the application of Prototype Provisions in the USA for development materials, continuously avoiding dutiable expenses at the time of importation • Accurately supported the on time delivery of supply chain materials with over 150 SAP transactions and Shipper Instruction generation, to support the nonstandard supply chains defined.

Rahway, New Jersey, Us

•Led a Materials Team of 11 people responsible for the planning, sourcing, inspection, storage and dispensing of incoming raw materials in support of Summit Pilot Plant Operations. •Led Multiple cross functional teams with representatives from development scientists, laboratories, quality assurance, inventory planners, and procurement to standardize common materials, suppliers, testing requirements and implement global reduced testing programs•Implemented multiple streamlined, just in time, material planning and ordering systems•Implemented various Lean Six Sigma systems (Tier, Flex Workforce, Kanban, 5s, DMAIC)•Managed the annual materials management operating budget •Chaired the Pilot Plant safety team and designed a comprehensive behavioral based safety Program •Implemented an on the dock ID analysis system and a special handling labeling system •Developed a novel approach to materials and warehouse management using the WERUM manufacturing execution system •Managed the global quality manual chapter on Materials and Inventory Control for the Global Development Pilot Plants •Implemented an importation management process designed to ensure US Customs, FDA, USDA and transportation requirements are met in support of supply chain deliveriesACHIEVEMENTS•Saved approximately $1.5 million in company charges related to material purchases, testing, shipping and storage •Maintained internal customer service levels and schedule adherence of > 95% across receiving, sampling, dispensing and shipping workcenters •Reduced value of inventory by 58% ($1.7 million) •Delivered 0 safety recordables and lost time incidents since 2011• Reduced material planning window for development campaigns by 50% •Delivered 0 critical observations in any QP or internal quality audits •Achieved >99% materials on location •Achieved a manager engagement score of >90% (of 100) •Achieved a >95% adherence to annual operating budget

Kenilworth, New Jersey, Us

- Led a materials team of 26 members with an operating budget of over 12 million dollars in the areas of material procurement, dispensing, sampling, shipping, and storage in support of Phase I- IV clinical products- Partnered with various customers in clinical supplies planning, clinical manufacturing, clinical quality assurance and clinical operations - Developed a high performing line supervisory team- Redefined area roles and responsibilities to centralize work and created standard working tools/ training materials - Streamlined area policies, practices and procedures - Managed the Domestic Processes for USDA permit ownership, FDA hold approvals, Custom Duty Payments and DEA controlled substance permit - Executed individual development plans across all team members - Built active scheduling and forecasting processes across the following workcenters: receiving, sampling, dispensing, shipping and destruction - Built a processes for inventory monitoring and material processing - Transferred, people, material and operations in support of three site closures - Lead a cross functional site team to ensure receiving, storage, and transportation compliance- Delivered specific facility upgrades to minimize inventory and streamline operationsACHIEVEMENTS- Achieved a $1.7 Million cost avoidance by insourcing work, reducing overtime, deferring spend on Material Purchases, and standardizing transportation schedules - Delivered a greater than 97% performance to schedule across all workcenters - Delivered a 70%- 80% reduction in cycle time of materials transactions - Saved over 7,000 labor hours by streamlining operations - Increased throughput ranging from 20%-35%- Delivered 0 critical observations across 3 regulatory agency, QP, and vendor audits- Reduced Inventory Levels by 18% while still delivering materials on time to customer- Decreased a previously existing Import Brokers Invoices Backlog of 1400 Items ($1.1 Million)

Kenilworth, New Jersey, Us

•Managed a team of 8 professionals in Investigations and Materials Dispositions (drug product and patient kits) to support Phase I- IV clinical products•Cross trained team to enable maximum flexibility/responsiveness in support of on-time delivery of materials •Redefined area roles and responsibilities to centralize work, streamline operations and maximize competencies•Re –engineered site investigation system, creating materials for root cause analysis and standard investigation content, and implementing Investigation Review Boards (IRBs)• Served as the business owner for the Trackwise information system delivery, approving User Requirements, Validation Plans, Prototyping Outputs, and Summary Reports •Built delivery accountability within team by base lining on- time batch record review performance, and implementing standard review times, business rules and performance targets•Delivered a standardized record observation review checklists and training materials to ensure compliance requirements•Measured and analyzed observation and investigation root causes and developed control plans to drive to 100% right first time execution •Developed System Performance Measures to manage overall health of Quality Systems •Developed a course on Drug Development milestones for Quality assurance personal and delivered course to 80 people •Executed individual development plans across all team members Achievements•Increased the lots of material disposition by approximately 130%•Delivered greater than 90% on time record review •Decreased overdue Investigations from 69 to 1•Improved on time Investigation Closure performance from 10% to Greater than 75%•Decreasing the amount of Overdue CAPA from 46 to 2•Reduced Investigations by 10% •Improved Investigation Quality and Root Cause Methodology Applied•Delivered on 8 Regulatory Commitments as part of the consent decree•Delivered 0 critical observations across 2 consent decree inspections

Us

•During the Consent Decree, led 2 cross functional teams across manufacturing, packaging, engineering, facilities, laboratories, quality assurance in the redesign of the Investigation Management System and Annual Product review systems.•Developed trackwise records and workflows, training materials, root cause analysis workshops, SOPs, and job aids to lead in the system implementation •Implemented SOP requirements for Annual Product Reviews content and management review of process control •Assisted in the finalization of Global Quality Standard requirements for the Investigation System ACHIEVEMENTS•Met 16/16 quality system milestone targets in the implementation of the Investigation Systems and the Annual Product Review System•Supported 4 Semi-Annual Regulatory Inspections as part of the consent decree •Trained over 100 colleagues on the use of the Trackwise Investigation Systems•Developed KPIs (Key Performance Indictors) for both the Investigations and APR (Annual Product Review) systems •Delivered 0 critical observations noted as part of the Investigations and Annual Product Review systems •Led an initiative that resulted in a 80% reduction of overdue investigations and an 80% reduction of overdue notifications to Quality Assurance

Us

•Reviewed investigations related to oral solid dose manufacturing products. Responsible for, conducting comprehensive technical investigations for manufacturing and OOS investigations, reviewing Annual Product Reviews to assess product trends, and reviewing offshore laboratory investigations for technical validity and compliance with company policy.

Us

•Supervised and coordinated all aspects of analytical testing. Responsible for: reviewing test results for final release of finished products, executing technical investigations (Including OOS), supervising method transfers, and compiling method assessments..•Coordinating the inception of an instrument support calibration group to remediate a pre-existing backlog

Bachelor Of Science, Chemistry

Master Of Business Administration, Management

Master Of Science, Chemistry