Senior Process Engineer (12 Month Contract)

The role

You will develop an aseptic manufacturing workflow for bioprinted tissue therapeutics. You will lead the design of fluidic systems, bioreactor scaling, and automated cell processing workflows.

What you will do

• Lead conceptualization, design, implementation and characterization of complex fluidic systems, bioreactor scaling strategies, and automated cell processing workflows.
• Ensure technical integration of the cell therapy process into the final device platform.
• Lead process risk assessments for the cell manufacturing process and medical device component.
• Develop mathematical models and implement DOE to define CPPs and CQAs.
• Support technology transfer to Manufacturing including process qualification and early phase clinical manufacturing.
• Provide technical support for troubleshooting and root cause analysis during manufacturing deviations.
• Work with Quality to define validation strategies for sterilization, biocompatibility, and E&L.
• Provide technical backbone for regulatory filings (CTA/IND).
• Identify gaps in cell therapy manufacturing and develop patentable technologies.
• Mentor others and foster technical excellence.

Required qualifications

• M.S. or Ph.D. in Chemical Engineering, Bioengineering, Biomedical Engineering, or a related life science field
• 6-8+ years of relevant industry experience, in cell therapy, bioprocess development, or biologics manufacturing
• Strong hands-on background in the development, characterization, and optimization of biomanufacturing processes
• Expertise in the design, implementation, and characterization of complex fluidic systems, including automated cell processing workflows
• Proven ability to develop mathematical models and apply statistical methods (such as Design of Experiments, or DOE)
• Thorough knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Familiarity with regulatory requirements for cell therapy products (e.g., providing technical content for CTA/IND filings)
• Experience supporting technology transfer from Process Development to Manufacturing, including process qualification and validation activities
• Strong analytical, problem-solving, and data-driven decision-making skills
• Excellent written and verbal communication skills

Nice to have

• Experience within cell therapy
• Experience with bioreactor systems and scaling strategies
• Direct experience operating within a Design Control framework (e.g., FDA 21 CFR Part 820) for medical devices

Benefits

• comprehensive benefits package
• support for continuous learning and career progression

Before you apply

• submit a general application to be considered for future opportunities if no job matches your experience

About the company

Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine. The company integrates proprietary AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials.