As a Process Improvement Specialist, you will play a critical role in leading technical activities for commercial manufacturing processes at Contract Manufacturing Organizations (CMOs). Your responsibilities will include:
* Authoring change control documents and managing process improvement projects
* Analyzing process performance and authoring/reviewing required Good Manufacturing Practice (GMP) documentation
* Providing on-site support at External Partners in support of Commercial and/or Technology Transfer Person-In-Plant Activities
* Translating GMP requirements and current regulations into standardized work by partnering with Operations, Quality, and External Partners
* Ensuring External Partners are inspection-ready for routine inspections or new product introductions/transfers
To be successful in this role, you will require:
* A Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology
* 4-5 years of drug substance technical transfer experience
* Minimum 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area
* Strong communication and teamwork skills, proven expertise in biologics drug substance upstream/downstream operations, analytical testing, process development, and tech transfer
* Demonstrated ability to independently manage projects/work to schedule/deadlines, statistics experience, deviation management, change control, project management