Sr. Engineering Associate/Associate Engineer, Drug Product Development en Century Therapeutics, Inc.

Description

  · 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’s next-generation manufacturing process

· Maintain laboratory procedures, systems and electronic notebooks, to ensure documentation of experimental activities

· Travel up to 10%

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

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