Robert Braddock Email & Phone Number

• Lead a team of industry experts dedicated to helping pharmaceutical, biopharmaceutical, radiopharmaceutical, specialty chemicals, and cell and gene therapy companies navigate complex regulatory landscapes, optimize manufacturing processes, and ensure operational excellence.

Springfield, New Jersey, Us

Newark, New Jersey, Us

• Established a strong manufacturing and supply chain infrastructure for clinical GMP operations, coordinating the development of policies, systems, and the recruitment of specialized personnel dedicated to advancing cell and gene therapies.• Developed and implemented strategic and technical controls for manufacturing and supply chain in line with the developmental blueprints for clinical supplies.• Led initiatives aimed at optimizing product performance by defining and closely monitoring key performance indicators (KPIs) that evaluate critical aspects.• Championed budget-critical projects across critical functions and sites, ensuring their completion in alignment with overarching business objectives and priorities.• Managed the complete value chain involving improvements in the product, technical modifications, sourcing strategies, launches, advancements in quality, and enhancements in productivity.• Coordinated planning and implementation of Chemistry, Manufacturing, and Controls (CMC) changes across various departments and locations to make sure that strategic initiatives, allocation of resources, and execution were aligned.• Overseeing supply risk evaluations and devising backup strategies, such as developing Annual Business Continuity Plans, to proactively address potential disruptions.• Directed manufacturing operations, materials management, supply chain logistics, maintenance, and engineering functions, until the business evolved to the point where each of these areas warranted its own dedicated organization• Possess extensive knowledge and experience in quality management systems and demonstrate a strong quality mindset.

Toronto, Ontario, Ca

• Leads and directs all aspects of the Berkeley Heights site, including Production, Engineering, Technical Services, Finance, Supply Chain, Logistics, Environmental, Health & Safety, Maintenance, Quality, Compliance and Human Resources.• Coordinates the execution of manufacturing schedules based on sales requirements and plant capacity.• Manage site finances including Profit & Loss (P & L) and Capital expenditures (Capex).• Ensures compliance with federal, state and local safety and environmental standards utilizing Process Safety Management standards.• Ensures regulatory and cGMP compliance with effective implementation of Quality Management System.• Develops, implements, and monitors plant-wide goals and objectives, utilizing KPIs both on a short and long-term basis.• Identifies and drives continuous improvement activities utilizing lean manufacturing and operational excellence techniques to reduce overall costs while maintaining efficiency and quality standards.• Controls supply planning, warehouse operations, logistics and distribution, procurement, and vendor management.• Oversees the maintenance of buildings and equipment, and plant security and protection.• Participates in final decision process for all major decisions impacting plant functions and operations.• Maintains final authority for resolving day-to-day plant operating and procedural issues.• Designed process flows for new multiproduct GMP pharmaceutical grade production facility.Key Achievements:• Zero product quality recalls• New multiproduct GMP pharmaceutical grade production facility for adjuvants• Increased current site revenue by 50%, production volume by 86% and maintained a Lost Time Injury Rate of zero by utilizing Process Hazard Analysis, Process Mapping and lean manufacturing concepts • Drove capital projects to improve utility efficiencies resulting in 35% cost savings over the last two years using lean manufacturing concepts

Cork, Ireland, Ie

• Ensured that the New Brunswick facility was operated and maintained in a cost-effective and safe condition in accordance with the approved budget and the customer’s requirements to fulfill O&M contractual obligations.• Reviewed and approved expenditures for tools, equipment, supplies, materials and additional contract requirements. Assisted with the preparation of facility budget.• Managed, directed and scheduled day-to-day and long-range activities for assigned properties and ensured that all programs and procedures of the O&M staff were being properly implemented.• Established process performance metrics; tracking, analyzing and reporting performance in terms of quality, safety, cost, and customer satisfaction. Took corrective action to bring about required change and ensured contract requirements have been executed at a level above the specified standards.• Managed contractor specifications, problems/issues, performance and administration.• Recommended solutions and implemented appropriate corrective action for major or complex maintenance issues.• Provided the technical and management direction for all GMP Facility Management services and utilized JCI resources to reduce costs and increase satisfaction.Key Achievements:• Reduced Maintenance work order backlog from 90 days to 15 days • Renovated emergency power systems for GMP critical facilities

Seal Beach , Ca, Us

• Developed and managed preventive maintenance programs, including new preventive maintenance procedures, work review and approval.• Assisted in the ongoing development and implementation an ISO/IEC 17025 compliant calibration program, including creation and revision of calibration SOPs and data sheets.• Managed exception reporting, corrective action and change control activities; troubleshot and performed root cause failure investigations.• Provided technical support to Facilities and other site departments as needed for troubleshooting, repairs and process optimization.• Managed internal plant capital projects as assigned, including scope development, estimating, budget, scheduling, change control and project management of design, construction, commissioning and validation support for sipuleucel-T immunotherapy manufacturing.• Managed contractors as required, including construction trades, calibration and maintenance.• Developed and maintained Facilities SOP's, including preventive maintenance and calibration.• Developed spare part requirements in conjunction with Facilities personnel.• Served as administrator for the BAS (Building Automation Systems) and EMS (cGMP Environmental Monitoring Systems).• Served as administrator for the emergency generation system, UPS (uninterruptible Power Supply), HPW (High Purity Water) systems• Supported administration of BMRAM program (Blue Mountain Regulatory Asset Manager) for preventative maintenance, calibration and equipment history.• Led a multi-discipline Failure Mode Effects Analysis (FMEA) team to identify possible sources of failure in an emergency power generation system. Key Achievements:• Developed and implemented a Predictive Maintenance Program involving Vibration Analysis, Thermography and Oil Analysis.• Managed design and construction of sipuleucel-T immunotherapy sterile injectables suites• Startup of the flagship site for first in kind FDA approved immunotherapy for prostate cancer

New York, New York, Us

• Conducted internal audits for Engineering, Maintenance, and Vaccines departments to ensure Maintenance calibration process compliance.• Managed investigations written by department engineers. • Investigated manufacturing discrepancies for Engineering, Maintenance, and Vaccines departments • Reviewed Engineering and Maintenance documents, training records, calibration records, Level I and II policies, standard operating procedures, regulatory policies, testing and manufacturing specifications, validation documents, and other technical documents.• Interacted and coordinated with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.• Investigated and identified root causes of manufacturing discrepancies.• Determined corrective actions and/or commitments.• Evaluated closed commitments to verify their completion and their effectiveness in root cause remediation. This included gathering the appropriate documentation, communicating with appropriate personnel, confirming effective root cause remediation, and/or recommending additional corrective actions when appropriate.• Provided monthly reporting and analysis of process and performance metrics of investigations and commitments.• Participated in cross-functional team reviews to resolve MIR (Manufacturing Investigation Reports) issues.• Ensured that all SOP mandated timelines were followed.• Maintained regulatory compliance by initiating MIR’s as needed and ensuring that departmental personnel document all manufacturing discrepancies and resulting changes, whether process, equipment, or procedural, as per regulatory and company policies.Key achievements:• Reduced Maintenance Calibration Out of Tolerance investigations by 30% utilizing Process Mapping and FMEA risk analysis as part of selected Six Sigma Green Belt project. • Presented and defended manufacturing investigations before the FDA and EMEA during site audits.

New York, New York, Us

• Facilitated commercial start-up of filling lines.• Supervised daily operations of Prev(e)nar syringe fill/inspection.• Ensured full operational compliance with all regulatory guidelines.• Responsible for line clearances, environmental monitoring, and scheduling.• Implemented training program based on area curricula.• Coordinated production activities with Bulk Production, Validation, Materials Management, Quality Control, QA, Lab Services, and Warehouse Departments.• Monitored and reviewed batch record and documentation entries throughout the Fill/Finish process.• Participated in internal, external and shop floor audits for FDA manufacturing approval.Key achievement:• Facilitated commercial startup of sterile injectable filling lines for a multibillion-dollar vaccine.

New York, New York, Us

• Performed fermentation and purification process studies for commercial scale up of immunoconjugates.• Drafted a Clean in Place procedure for fermentation process equipment.• Performed experimental work required to close commitments related to FDA 483 responses.• Served as technical support on investigations related to manufacturing deviations.• Assisted in the startup of equipment used in the clarification process of polysaccharide production.• Generated Piping and Instrumentation Diagram of Biofermentor system for training purposes.• Performed experimental work to implement improvements in the production areas with emphasis on closed systems.• Collaborated in data analysis, data management, and Tech transfer activities for the fermentation and purification processes of polysaccharide production using Statistical Process Control (SPC) implementation and data interpretation.Key achievement:• Successful commercial scaleup of multibillion-dollar vaccine.

Master Of Science (M.S.), Chemical Engineering

Bachelor Of Science (B.S.), Business Administration And Management, General

Bachelor Of Science - Bs, Business Administration And Management, General