Process Engineer

How you’ll make an impact:

This role sits at the core of our technical development and operations strategy, leading the technology transfer and manufacturing support to internal and external collaborators (CMOs/CDMOs). In this role, you will serve as a key technical subject matter expert in these areas; lead internal cross-functional teams in technical execution and decision-making and serve as the 2seventy representative to our external partners.

As the CPD Process Engineer, we will empower you to leverage your deep technical expertise of our in-house manufacturing process, steering our programs to our clinical and commercial manufacturing facilities and influencing decision making together with manufacturing, quality, and supply chain.

This role ensures 270’s innovative cell therapies developed on the benchtop to reach patients’ bedside as smoothly as possible, a win-win for the patients and our company.

About the team:

270's Cellular Process Development team is a group in the Process Sciences Department developing and characterizing processes to manufacture high quality T cell products 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 Process 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!

How you’ll spend your time:

• Become an SME in cell therapy manufacturing process developed by the Cellular Process development team through working with development scientist and hands-on experience
• 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
• Collaborate with manufacturing and quality at CMOs or 270 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

Who you are and what you’ve accomplished:

• 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.
• The Process Engineer should have a MS with at least two years of experience working in cell, gene, and biologics industry, or a BS with at least 3 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 1 year hands on experience in transfer of technology in pharmaceutical, biotech or food manufacturing industries
• At least 1 year experience authoring protocols, and reports required for process performance qualification