Senior Process Engineer – Cell Therapy Bioprocess

Aspect Biosystems Ltd.

Vancouver

Hybrid

CAD 125,000 - 132,000

Full time

4 days ago
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Job summary

Aspect Biosystems Ltd. in Vancouver, BC, seeks a Senior Process Engineer to advance aseptic manufacturing workflows for bioprinted tissue therapeutics.

This 12‑month contract involves leading design, scaling, and automated cell processing with a focus on closed systems and single-use tech, while aligning with GMP/GDP and regulatory expectations. You’ll model CPPs/CQAs, perform risk assessments, and support technology transfer to manufacturing, including early clinical manufacturing support, with

Qualifications

  • Education + Experience: MS/PhD and 6‑8+ years in cell therapy/bioprocess development.
  • Hands-on development, characterization, and optimization of biomanufacturing processes.
  • Experience with bioreactors and scaling strategies.
  • GMP/GDP knowledge and regulatory familiarity for cell therapy products.
  • Technology transfer from Process Development to Manufacturing including sterilization and E&L.
  • Strong analytical and communication skills; ability to mentor.

Responsibilities

  • Lead conceptualization, design, and characterization of fluidic systems and bioreactor scaling.
  • Collaborate with Process Development, Bioengineering, Engineering, and Manufacturing to integrate the process with the device platform.
  • Lead process risk assessments (FMEA, PHA) for manufacturing and device interaction.
  • Develop mathematical models and apply DOE to define CPPs and CQAs.
  • Support technology transfer and process qualification to Manufacturing; assist early phase clinical manufacturing.
  • Provide troubleshooting support and conduct root cause analysis during manufacturing deviations.
  • Work with Quality on validation strategies for sterilization, biocompatibility, and E&L; assist regulatory filings.
  • Identify gaps and develop patentable process improvements; mentor junior team members.

Skills

Process development & characterization
Bioprocessing
DOE (Design of Experiments)
GMP & GDP knowledge
Technology transfer
Bioreactor scaling
Analytical & communication skills

Education

M.S./Ph.D. in Chemical/Bio/Biomedical Engineering or related life science

Tools

Bioreactor systems
Design controls
Process transfer tooling

Job description

Aspect Biosystems Ltd. in Vancouver, BC, seeks a Senior Process Engineer to advance aseptic manufacturing workflows for bioprinted tissue therapeutics.

This 12‑month contract involves leading design, scaling, and automated cell processing with a focus on closed systems and single-use tech, while aligning with GMP/GDP and regulatory expectations. You’ll model CPPs/CQAs, perform risk assessments, and support technology transfer to manufacturing, including early clinical manufacturing support, with

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