Sr. Engineering Associate/Associate Engineer, Drug Product Development

Role Summary

Sr. Engineering Associate/Associate Engineer, Drug Product Development

Responsibilities

• Develop and implement manufacturing processes capable of supplying clinical trials with material complying to product quality targets, current Good Manufacturing Practices (cGMP), and regulatory requirements
• Support the delivery of engineered immune cells to internal and external groups
• Identify novel solutions to address key technical challenges required for manufacturing platform success, such as cryo-preservation and cell culture media optimization
• Contribute to experimental strategy toward at-scale cell differentiation, expansion, formulation, and in-process testing
• Collaborate with internal partners (Process Development, Analytical Development) to integrate stem cell process technology and optimize Century‚Äôs next-generation manufacturing process
• Maintain laboratory procedures, systems and electronic notebooks, to ensure documentation of experimental activities
• Travel up to 10%

Qualifications

• BS/MS degree in cell biology, biochemistry, biochemical engineering, or related field, ideally with 2-6 years of relevant industry experience
• Functional experience in mammalian cell culture process development, including molecular biology, aseptic techniques, and cryo-preservation

Requirements

• Experience with mammalian cell culture and media optimization
• Experience with Rotea, LOVO, Xuri, and other cell culture unit operations is preferred
• Understanding of cell biology/physiology and/or engineering fundamentals. Experience with induced pluripotent stem cells (iPSC) is desirable
• Understanding of bioprocess characterization and validation concepts, cGMP, and GLP
• Dynamic and culturally astute team-player, scientifically rigorous with excellent communication skills