Process Engineer / Senior Process Engineer

270's Cellular Process Development team is a group in the Pharmaceutical Sciences Department developing and characterizing processes to manufacture high quality reprogrammed T cells for our patients. We develop and characterize the cell therapy manufacturing platforms and chaperone them from pre-clinical to commercial manufacturing phases in collaboration with other teams across Pharmaceutical Sciences, Analytical Development, and Research. Come join our incredibly talented team and learn more about how the work from this team has a significant impact in patient’s lives.

We are seeking a Process Engineer / Senior Process Engineer to represent our Cellular Process Dev group in discussions facilitating technical, program leadership, and technology transfer to internal and external collaborators (CMOs/CDMOs).

What you'll do:

· Exhibit a good knowledge of regulatory and quality standards when it comes to developing, transferring, and validating of drug processes from the process design stage through continued process manufacturing

· Understand facility build out, cGMP and GMP requirements when it comes to equipment specification, and cell therapy manufacturing

· Experienced with developing and overseeing Tech-Transfer protocol from either development lab or established CDMO to new CDMO sites

· Collaborating with MSAT counterpart at CMOs to deliver timely and correct technical solutions to resolve investigations and to improve manufacturing performance and reliability

· Responsible for the planning, overseeing, and reporting of executed studies related to process performance qualification and associated validation activities

· Provide guidance and mentoring to team members

What you'll bring:

· The Senior Engineer should have a Ph.D. in a science related field centered on cell and biologics with at least 4 years of experience working in the cell, gene, and biologics Industry, or a MS with at least 6 years of relevant experience, or BS with at least 8 years of relevant experience.

· Experience in functional representation or matrix leadership within a cross-functional team (preferably a CMC team)

· Understanding of quality by design (QbD) approaches

· At least 3 years hands on experience in transfer of technology in pharmaceutical, biotech or food manufacturing industries

· At least 3- 5 years' experience authoring protocols, and reports required for process performance qualification