Role:
Senior Specialist in Engineering for Biologics External Manufacturing Technical Operations, focusing on drug substance tech transfer and commercial production within the external manufacturing network.
Responsibilities:
lead technical transfer activities, serve as primary interface with external partner drug substance manufacturers, author/review GMP documentation, manage process improvements, and support regulatory inspections. Ensure external partners meet GMP compliance and inspection readiness, develop standardized work, and drive continuous technical excellence.
Requirements:
Bachelor's in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry, or related field; 8+ years post-bachelor's GMP experience in operations, engineering, or technical support; strong problem-solving, communication, and organizational skills; ability to work independently and multi-task under tight deadlines.
Preferred:
experience in biologics or large molecule manufacturing, project management, deviation/change management, and knowledge of global regulatory requirements.
High Value:biologics/vaccines manufacturing, drug substance tech transfer, GMP compliance, sterile processes, regulatory support, 25% travel.
Work Setup:in-office with travel.
