As a Senior Process Engineer, you will provide cross-functional leadership and technical oversight at our contract manufacturing site. You will serve as the technical person-in-plant, offering on-the-floor support to ensure manufacturing excellence. Your responsibilities include managing technology transfers and manufacturing operations for all new and existing Cell Therapy Manufacturing assets. Additionally, you will develop process trending tools, provide process improvement recommendations, and play a key role in the lifecycle management of Abata Therapeutics's cell therapy products.

What you’ll do

• Serve as the technical representative at the contract manufacturing site, offering on-the-floor technical assistance to optimize manufacturing operations (Person-in-Plant).
• Collaborate with cross-functional teams, including the CDMO joint project team, Abata Process and Analytical Development, Quality Assurance, Quality Control, and Regulatory to ensure the efficient execution of clinical manufacturing operations and the transfer of new assets and process enhancements within agreed timelines to support business objectives.
• Review GMP-executed manufacturing batch records
• Support Deviation Management, CAPA, and Change control to ensure timely batch release.
• Manage the drafting of technical documents, such as master batch records and components of technology transfer packages
• Function as a manufacturing subject matter expert within the MSAT organization
• Collect and analyze manufacturing data to identify areas for improvement
• Develop and deliver training materials to ensure the operational and scientific training of all employees involved with new processes and product introductions.

What we’re looking for

• BS/BA in Chemical, Biological or Biomedical Engineering with 8+ yrs or MSc with 6+ yrs or equivalent combination of education and work experience
• 2+ years of experience in cell therapy manufacturing
• Proven experience with process technical transfer, technical operations, and lifecycle management
• Detail-oriented with excellent problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment

What will separate you from the crowd

• Experience with cell therapy manufacturing processes and equipment, including T cell isolation, cell sorting, lentiviral transduction, gene editing, expansion in bioreactors, cell harvest, and cryopreservation
• Well-versed with cGMP requirements and working in a regulated environment
• Prior experience supporting tech transfers to external partners
• Knowledge of R, Python, JMP, Spotfire

What you should know

• Local travel up to 50% of the time (currently, Waltham to Watertown)
• Work in a grade B space, including sterile gowning
• Some weekend work
• This position requires handling of human blood products