Senior Process Engineer: Cell Therapy Tech Transfer

RoslinCT

Hopkinton (MA)

On-site

USD 140,000 - 200,000

Full time

14 days+

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Job summary

RoslinCT is seeking a Senior Process Engineer to lead technology transfer for partner programs and optimize manufacturing processes. You will collaborate with Manufacturing, Quality, Facilities, and Operations, and support deviations, CAPAs, and product disposition evaluations.

The role involves developing and executing transfer plans, drafting batch records, and ensuring right-first-time execution, with a focus on quality, efficiency, and reliability from clinical development through

Qualifications

Requires 5–10 years of relevant process/analytical experience in CGT.
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 independent experimental design, data analysis, and troubleshooting.
Excellent technical writing and communication skills.
Proficient with Excel and statistical data analysis.

Responsibilities

Lead New Product Introduction for products entering RoslinCT facility.
Collaborate with Operations, Quality Control, and Quality Assurance as well as external clients to execute technology transfer, equipment setup and qualification, engineering and training runs, and process validation as applicable.
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.