Senior Process Development Engineer II
Kindeva Drug Delivery · Lexington, Kentucky, US
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make:...
Job description
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make: Join a rapidly expanding pharmaceutical CDMO where your work directly enhances the scalability and efficiency of life-changing treatments. As a Senior Process Development Engineer, you will lead and coordinate the transfer of pharmaceutical products and manufacturing processes between R&D and commercial manufacturing sites. You’ll ensure processes are scalable, robust, and compliant with regulatory standards. Your expertise will shape systems, equipment, and SOPs while supporting the production of finished pharmaceutical products. Responsibilities: Technology Transfer - Plan and execute technology transfer activities for drug products or devices from R&D to manufacturing or between commercial sites - Author and/or review tech transfer documentation (e.g., process descriptions, gap assessments, risk assessments, readiness assessments, protocols) - Translate lab-scale processes into commercial manufacturing processes Process Optimization & Troubleshooting: - Support scale-up activities and resolve technical issues during manufact...