Navin Ramnarain
Toronto,Canada
Summary
Adept at spearheading complex projects in vaccine production and diagnostics, I excelled at Sanofi Pasteur Ltd by leading Tier 1 projects and significantly enhancing operational efficiency with over 90% uptime. My strategic planning prowess and effective team management have been pivotal in achieving stringent regulatory compliance and fostering stakeholder engagement.
Overview
26
26
years of professional experience
Work History
Dep Director-Commissioning & Qualification Lead (C&Q)
Sanofi Pasteur Ltd
06.2021 - Current
- Lead development of Strategy, Planning and Execution of C&Q activities for Tier 1 projects in new vaccine facilities, B100, FFIP and PPD projects
- Successfully developed Commissioning Test Plans, Validation Master Plans and Commissioning strategies for facility systems, process systems and equipment for Sanofi new vaccines facilities
- Including computer systems validation
- Lead highly efficient team for qualification activities including, document preparation, execution, and handover, manage team of 25 (process engineers, commissioning, and documentation specialist) tasked with developing and executing tests to challenge the facility and process systems operating capabilities
- Accountable for reviewing and assessing impact of changes to the qualification status of process, ensuring compliance, and minimizing impact
- Responsible for driving key deliverables to meet project schedule, budget, and resource plans, managing interfaces between project engineering functions (CM, process engineering, automation, C&Q) to optimize project timelines and drive results
- Lead process-related investigations, troubleshooting, changes, CAPAs and liaise with internal customers, and stakeholders to support manufacturing operations
- Successfully executed the role of CQ lead as well as Process engineering Lead for the basic, and detailed design phases of the PPD Tier1 project
Dep Director-Technical Services APU Lead
Sanofi Pasteur Ltd
01.2018 - 06.2021
- Accountable for overseeing and prioritizing maintenance, engineering, and reliability activities in B90 facility producing DTPPD
- Successfully keeping the facility operational with > 90% up time
- Accountable for managing budget, timelines, and resource allocations for maintenance execution to achieve repeatable reliable operations in manufacturing facility
- Improved facility performance by developing robust reliability and monitoring program
- Responsible for planning and coordinating on time execution of maintenance and project activities in collaboration with operational departments and support functions, ensuring quality and technical requirements, schedule adherence and cost requirements are achieved
- Mentored maintenance managers and trades, site engineers, and contractors by continuously providing training direction
- Directly managed planners, schedulers as well maintenance managers and staff
- Implemented metrics to monitor Key Performance Indicators, ensured actions are taken to continuously improve performance
- Effectively cascade information and decisions to management and operational personnel
- Responsible for Identifying root causes of production/utility equipment issues and implementing improvements in reliability and performance
- Use data driven approach and lean principles to perform RCA and cost benefit analysis
Dep Director -SAP Manufacturing Lead
Sanofi Pasteur Ltd
01.2017 - 01.2018
- Site Project lead and Subject matter expert for SAP Production planning and inventory management module, responsible for the development of Recipes, BOM and material specifications
- Developed road map for completing and executing design, development, and validation of computerized software
- Including writing, reviewing, and approving design, commissioning, and validation documents
- Performed strategic role in aligning, strengthening and simplify Industrial Business Processes including that of the SAP system as well as its integration in the Information Technology System landscape of the site
- Led team tasked with Identifying gaps and remediate master data in SAP for planning, manufacturing, and costing modules including, BOM, costing, and resource scheduling
- Implemented and managed Obeya to track and manage project timeline, cost and resource requirements
Dep. Director Bulk Polio Production
Sanofi Pasteur Ltd
01.2008 - 01.2017
- Accountable for the performance of a bulk antigen production facility, with the support of 5 direct and 40 indirect reports
- Provide direction and implemented manufacturing strategy
- Successfully led manufacturing operations in the production of bulk Inactivated polio vaccines (IPV) in a cGMP compliant Level 3 facility
- Accountable for safety, quality, budget, and antigen delivery performance of the production platform
- Managed budget, production schedule, resource allocation and training
- Utilized Lean Principles, SMS and Root Cause Analysis to effectively manage operations
- Successfully engaged, mentored, and led cross functional teams (HSE, production, quality, engineering, maintenance regulatory, supply chain and Industrial Performance) to deliver quality bulk antigen within budget and on time
- Accountable for ensuring raw materials and intermediate are available to meet manufacturing requirements
- Ensured availability of released raw materials and intermediates by proactively identifying supply chain and quality constraints
- Ensured compliance to quality and safety standards
- Successfully represented the vaccine facility at internal and external regulatory and safety audits
- Responsible for ensuring facilities and equipment operate in compliance with regulatory requirements, procedures are followed, and records are completed in a timely and accurate manner
- Developed mid- and long-term strategic plans for managing and mitigating critical raw materials supplies, facility, and equipment issues in collaboration with support functions partners
- Directed the incorporation of new technologies in the manufacturing upstream and downstream manufacturing process
- Ensured facilities and equipment are designed, validated, and maintained to continuously improve safety, compliance, quality, and productivity
- Pioneered the incorporation of single use technologies in media and bulk vaccine production
- Drove action to ensure deviations are minimized and root causes are identified and corrected
- Managed CCR, CAPA and Deviation life cycle to ensure on time closure
- Established annual departmental operating budget, and controlled spending according to budget
- Accountable for the identification of root causes and remediation of production issues, utilized lean principles, risk assessment and Statistical Process control methodology to drive improvements in quality, production, efficiency, and yield
Director Operations
SQI diagnostics Inc.
01.2006 - 01.2008
- Company Overview: Diagnostics Tests Manufacturer
- Directed the routine operational and strategic activities of a multi-functional team involved in the technology transfer, scale up and commercial manufacturing of ELISA test kits for human diagnostics use
- Lead team responsible for incorporating automation technologies and electronic records in manufacturing and analytical processes
- Directed the supply chain, technology transfer, Validation, and Manufacturing operations
- Managed the supply of critical material from over 20 suppliers on three continents
- Provided direction and strategy in the creation and approval of protocols, reports, SOPs, MBPRs and specifications associated with validation and operational documents
- Determined and managed operational budget
- Accountable for variances in spending and delivery
- Actively led the recruitment and training, of operational personnel
- Hired 3 managers and 15 operational staff
- Took action to ensure to ensure team was trained and engaged
- Member of the senior management providing direction to the company’s project management, supplier review and design change control teams
- Led team tasked with construction of a pilot cGMP manufacturing facility including installing and validating equipment
- Successfully transformed SQI diagnostics from a research and development site to a commercial manufacturing site
- Obtaining ISO 13485 certification for commercial production of test kits
- Diagnostics Tests Manufacturer
Manufacturing /Process Development Manager
Lorus Therapeutics Inc.
01.2003 - 01.2006
- Company Overview: Immunotherapeutic Manufacturer
- Managed the procurement of APIs, critical raw materials, services, and equipment
- Successfully managed the global drug supply chain for clinical programs involving three products in nine clinical trials
- Proactively identified current and future supply chain risks developed and implemented contingency plans
- Ensured quality secondary suppliers and approved alternate materials were secured
- Responsible for management/oversight of manufacturing, technology transfer, process scale up and optimization at CMO's and service providers for the company's products and processes
- Negotiated quality and supply agreements, service contracts ensuring agreements were met within expected timelines
- Responsible for the life cycle management of SOPs, mBPRs, and other Department Procedures to meet local and global regulatory commitments well as safety and environmental requirements
- Developed and implemented standard policies and procedures for evaluation and selection of suppliers, service providers, CMOs, consultants and vendors
- Directed and lead the Process Development and validation group’s activities to support technology transfer, optimization and scale up of the manufacturing processes
- Immunotherapeutic Manufacturer
Commissioning and Qualification Manager: Operations
Hemosol Inc.
01.2001 - 01.2003
- Company Overview: Blood Products Manufacturer
- Responsible for and coordinating the activities of six teams each consisting of engineers, validation specialists, quality assurance specialist, construction personnel and consultants in SAT and FAT, Commissioning and qualification of equipment at Hemosol’s commercial manufacturing facility
- Successfully supported the implementation from a green field to full validated aseptic blood product facility
- Provided leadership and expertise to engineering and validation teams in the design and qualification of utilities and process equipment as well as worked collaboratively with quality and regulatory functions
- Managed the creation and revisions to process and equipment validation documentation for the commissioning and qualification of a commercial scale aseptic blood product manufacturing facility
- Provided leadership and direction in the execution of protocols for process validation and equipment qualification, adhering to corporate procedures, FDA Regulations, and Industry current practices while maintain strict adherence to project timelines
- Blood Products Manufacturer
Process Specialist (Team Lead): Technical Support
Hemosol Inc.
01.1999 - 01.2001
- Company Overview: Blood Products Manufacturer
- Developed and maintained expert knowledge database of the manufacturing process for Hemosol’s blood-based product, provided support to production teams in resolving production issues and deviations
- Developing CAPAs and CCRs to remediate process issues and improve robustness
- SME for production process
- Serve as a technical resource for manufacturing operations; responsibilities include implementing new technologies and equipment; monitoring on-going production activities
- Successfully led the activities of a multifunctional team to construct, qualify and start up a 10X scale up of Hemosol’s pilot plant used to manufacture phase III clinical trial material
- Responsible for the generation, review and approval of equipment specifications, procurement of equipment, and services relating to cGMP manufacturing process
- Blood Products Manufacturer
Education
MSc - Biotechnology
Dublin City University
Dublin Ireland06-1992
BSc. - Biotechnology
Dublin City University
Dublin Ireland06-1988
Skills
- Employee Development
- Strategic planning
- Issues resolution
- Change management
- Coaching and mentoring
- Verbal and written communication
- Industry knowledge
- Problem-solving
- Collaborative Team Leadership
- Regulatory compliance
- Project management
- Team management
- Stakeholder engagement
- Team building
Timeline
Dep Director-Commissioning & Qualification Lead (C&Q)
Sanofi Pasteur Ltd
06.2021 - Current
Dep Director-Technical Services APU Lead
Sanofi Pasteur Ltd
01.2018 - 06.2021
Dep Director -SAP Manufacturing Lead
Sanofi Pasteur Ltd
01.2017 - 01.2018
Dep. Director Bulk Polio Production
Sanofi Pasteur Ltd
01.2008 - 01.2017
Director Operations
SQI diagnostics Inc.
01.2006 - 01.2008
Manufacturing /Process Development Manager
Lorus Therapeutics Inc.
01.2003 - 01.2006
Commissioning and Qualification Manager: Operations
Hemosol Inc.
01.2001 - 01.2003
Process Specialist (Team Lead): Technical Support
Hemosol Inc.
01.1999 - 01.2001
MSc - Biotechnology
Dublin City University
BSc. - Biotechnology
Dublin City University
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