Senior Manufacturing Engineer/Manufacturing Engineer

Overview

The engineer will be responsible for leading the upstream and downstream GMP manufacturing team at our Fall River location and support the continuous improvement efforts to ensure reliability, efficiency, and staff development.

Responsibilities

• Lead the technical aspect of the upstream and downstream GMP manufacturing team at Celldex
• Assist in developing and administering budgets, schedules, and performance requirements.
• Interact on a regular basis with Process Development, Assay Development and Manufacturing.
• Support of the development, optimization, and assessment of new process technologies, as well as the scale-up and technology transfer of processes from PD to Manufacturing.
• Act as a liaison with external parties on matters relating to procurement of services and materials for the products manufactured at the Fall River site.
• Support the manufacturing operators during processing as needed.

Qualifications

• B.S./M.S./. in Biology, Biochemical Engineering or Chemical Engineering, or the equivalent experience
• 8 – 10 years biotechnology/biopharmaceutical industrial experience for Sr. Manufacturing Engineer. 4-8 years of experience for Manufacturing Engineer.
• Lead the upstream and downstream GMP manufacturing team at Celldex Fall River and support the continuous improvement efforts to ensure reliability, efficiency, and staff development
• Skilled in downstream processing of therapeutic proteins, including chromatography (utilizing Unicorn software), viral clearance/inactivation, filtration, and formulation.
• Skilled in upstream cell culture and single use bioreactors utilizing DeltaV a plus.
• Strong experience writing and implementing batch records and SOPs in a cGMP environment.
• The ability to work independently and as part of a team with creativity and flexibility.
• The ability to work with limited supervision by drawing on previous experience, good judgment and standard procedures.
• A sound understanding of experimental design.
• The ability to analyze data, prepare reports, and make technical presentations.
• Strong communication and organizational skills.
• Computer skills with Excel, Word, Project, and PowerPoint.