Process Development Specialist
This role supports the introduction of new products, technology transfer, and lifecycle changes for syringe products from a process development perspective.
The ideal candidate will have a strong background in science or engineering, with experience in commercial drug product processing. They should possess excellent problem-solving skills, communication skills, and leadership abilities.
Key Responsibilities:
* Lead new product introductions and lifecycle changes from a process development viewpoint.
* Provide process development subject matter expertise for these products post-transfer.
* Contribute to regulatory filings throughout the authoring, editing, and submission process.
* Respond to regulator inquiries as needed.
Requirements:
* Strong educational background in science or engineering.
* Experience in commercial drug product processing.
* Excellent problem-solving skills, communication skills, and leadership abilities.