Developing and implementing manufacturing processes from concept through production in a cGMP environment. Focus on coating and mixing processes.
Managing specific project deliverables on time and within budget working with a project team of peers.
Planning process development trials, Design of Experiments, writing development plans, and managing material and equipment demands.
Conducting statistical analysis and process optimization on trial results and summarizing findings in technical reports.
Executing development and clinical production on pilot and commercial scale equipment.
Creating and revising quality system documents, including Standard Operating Procedures and Work Instructions.
Providing support for production runs, including troubleshooting equipment and manufacturing events.
Leading and supporting Continuous Improvement Projects (CIPs) and Corrective/Preventive Actions (CAPAs).
Providing support for regulatory submissions, FDA responses and audits.
Working with customers to provide updates on project statuses.