Process Development Engineer II, Tech Transfer & Logistics

Role Summary

Regeneron, located in Tarrytown, NY is seeking an energetic Process Development Engineer II to support technology transfer and business operations in the Technology Transfer & Logistics (TT&L) group within Preclinical Manufacturing and Process Development. In this role, you will lead production process transfer to support preclinical and clinical manufacturing at internal and external sites, as well as manage and coordinate a wide variety of departmental business operations.

Responsibilities

• Lead cross-functional teams to complete development, transfer, and establishment of production processes at internal and external clinical manufacturing facilities, with a focus on late-stage programs.
• Work to ensure the successful start-up of manufacturing production campaigns.
• Drive team cooperation to facilitate resolution of cross-functional issues and/or provide value-adding solutions.
• Ensure effective, accurate and timely communication across functional areas and within project/program teams.
• Serve as a primary contact for management within and outside team regarding progress on project/program goals.
• Build and maintain detailed timelines for development and transfer activities
• Ensure official process related documentation is generated, reviewed, and delivered through quality systems in a timely fashion.
• Anticipate and address issues in manufacturing related to process, documentation, or training and assist in the management and implementation of process changes and operational improvements at the manufacturing site
• Lead recurring and ad-hoc technical teams to troubleshoot technical issues, implement new technologies, systems, or tools, and/or brainstorm and implement improved business processes and workflows.

Qualifications

• Required: Bachelor’s and/or Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry or related field, with an interest in Operations, Project Management, and Business.
• Required: 5+ years (Bachelor’s degree) or 3+ years (Master’s degree) of work experience in the biotechnology or pharmaceutical industry.
• Required: Strong customer focus and orientation; good knowledge of research principles, theories, design and implementation.
• Preferred: Interest in Operations, Project Management, and Business.

Education

• Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biochemistry, Chemistry or related field.

Skills

• Cross-functional team leadership
• Project management and process transfer
• Documentation and quality systems familiarity
• Effective communication and stakeholder management
• Problem-solving and continuous improvement