Senior Process Engineer, Cell Therapy & Tech Transfer

RoslinCT US; Hopkinton (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

RoslinCT in Hopkinton, MA is seeking a Senior Process Engineer to lead technology transfer for partner programs, collaborate with Manufacturing, Quality, and Facilities, and optimize manufacturing processes through clinical development to commercialization.

You will draft GMP batch records, support GMP production with troubleshooting and deviations, conduct feasibility studies, and compile comprehensive data packages to drive process improvement and ensure right-first-time execution.

Qualifications

• Bachelor’s degree in Biological, Biomedical or Chemical Engineering with 5–10 years of experience.
• Hands-on aseptic manufacturing and cell culture experience.
• Experience with cell therapy equipment support and troubleshooting.
• Proficiency with quality systems (deviations, CAPAs, change controls).
• Strong technical writing and oral communication skills; Excel and data visualization skills.

Responsibilities

• Lead technology transfer for RoslinCT partner programs.
• Collaborate with Operations, Quality Control, and Quality Assurance as well as external clients and suppliers to execute technology transfer, equipment setup and qualification, engineering and training runs, and process validation.
• Draft GMP Batch Records and SOPs to support partner programs and right-first-time execution by Manufacturing.
• Support GMP production with process or equipment troubleshooting, deviation investigations, and CAPAs, as needed.
• Execute feasibility testing of new or alternative technologies and engage with key stakeholders to ensure technology development alignment with RoslinCT and client program requirements.
• Collaborate with partners to experimentally determine key process and product monitoring and control attributes, analyze results and draft technical reports.
• Perform test runs and development studies as needed to support client and RoslinCT initiatives.
• Compile comprehensive data packages, operating procedures, and technical documentation to support technology transfer and process improvement.
• Be proactive in identifying opportunities to add value to processes and cross-functional teams.

Skills

Aseptic manufacturing

Cell culture

Analytical data analysis

Technical writing

Oral communication

Education

Bachelor’s degree in Biological, Biomedical or Chemical Engineering

Tools

Microsoft Excel

Statistical software

Job description

RoslinCT in Hopkinton, MA is seeking a Senior Process Engineer to lead technology transfer for partner programs, collaborate with Manufacturing, Quality, and Facilities, and optimize manufacturing processes through clinical development to commercialization.

You will draft GMP batch records, support GMP production with troubleshooting and deviations, conduct feasibility studies, and compile comprehensive data packages to drive process improvement and ensure right-first-time execution.