Job Title: Bioprocess Engineer Position
Description:
We seek a highly skilled professional with expertise in biologics drug substance upstream and/or downstream purification unit operations to support clinical and commercial new product introduction projects.
* Participate in and lead technology transfer activities to ensure seamless execution of new product introduction projects.
* Develop and execute process and clean validation programs aligned with industry and regulatory standards.
* Act as process Subject Matter Expert in investigations, utilizing risk management techniques to prioritize activities and initiatives.
* Lead business-critical projects associated with new product introduction and site capability development.
* Ongoing optimization of process equipment and development of future breakthrough solutions.
Requirements:
* Experience in biologics drug substance environment.
* Technical expertise in biological drug substance upstream and/or downstream purification unit operations required.
* Strong background in technology transfers for clinical or commercial biologics desired.
* Automated systems experience highly desirable.
* Process validation and cleaning validation expertise desired.