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.

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.
• 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.

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.
• 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.

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.
• Managed contractor specifications, problems/issues, performance and administration.
• Recommended solutions and implemented appropriate corrective action for major or complex maintenance issues.

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.
• Managed contractors as required, including construction trades, calibration and maintenance.

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.
• Interacted and coordinated with appropriate personnel including manufacturing, QA/QC, regulatory, technical services, etc.
• Investigated and identified root causes of manufacturing discrepancies.

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.

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.

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