Role:
Process and Technology Transfer Engineer I supporting drug delivery within Supernus's CNS-focused biopharma operations.
Responsibilities include overseeing technology transfer to CMOs, supporting manufacturing scale-up, process registration, validation, and process improvements; preparing technical and regulatory documentation; and collaborating on formulation development.
Requirements:
Bachelor's in engineering or related field; 2+ years in manufacturing, process development, or transfer; experience with cGMP, process validation, and technical writing; proficiency in data analysis and statistical tools preferred.
High-Value: supports clinical and commercial manufacturing, process validation, regulatory documentation (IND, NDA, IMPD, CTA), and cross-functional collaboration; travel varies from 20-90% depending on project phase.
Work setup involves both laboratory and office environments, with physical requirements including lab PPE.
