Package Qualification
Drive the development, qualification and implementation of packaging systems (primary, secondary and cold-chain).Process Development
Develop business and operational process designs to meet clients unique packaging & labeling needs.Project Management
Oversee the planning, initiation and execution of critical project timelines to meet client milestones for both clinical and commercial projects.Clinical Trial Execution
Design and qualify packaging solutions, ensure timely delivery of materials to study sites, support protocol development and execution.Cold-Chain
Provide services in sourcing & qualification of cold-chain solutions that meet client expectations or unique requirements.Troubleshooting
Support the troubleshooting of general packaging and labeling operational issues utilizing six sigma green belt tools.Consulting Services
- Oversee packaging initiates, working closely with cross-functional departments & suppliers, to develop & qualify holistic package & labeling design that meets client’s expectations in regards to stake holder requirements, budget and timing.
- Function as “point of contact” between contract manufacturing sites and client to ensure appropriate process development, process validation and procedure development is in place to support clinical trials and commercial launches.
- Support line trials, validation activities and campaign pack-outs with client teams & suppliers to ensure timely delivery of materials to contract manufacturers and clinical study or human factor testing sites.
- Drive the process development of packaging and labeling systems, including process mapping and associated GMP documentation. Designs created will meet client’s unique requirements while utilizing risk-based qualification methods and design controls for complete package systems in a start-up or commercial environment.
- Develop and execute packaging qualification plans to align with design control procedures and program expectations. Experience includes primary, secondary, tertiary, cold-chain and labeling components.
- Provide project management services through the planning, initiation and execution of critical project timelines. Maintain communication with senior leadership and obtain agreed upon methods for stake-holder buy-in through project lifecycle.
