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Downstream Process Development Jobs in Ontario (NOW HIRING)

Spectrum Plastics Group

Create design guidelines for tooling, die design, and downstream equipment integration. * Define critical process parameters (CPPs) and control strategies. Technology Development & Innovation

Magna

Senior Process Engineer

Guelph, ON · On-site

... development prospects. Because we believe that your career path should be as unique as you are ... Engage downstream internal customers to understand their requirements and translate feedback into ...

Next Generation

Process Engineer - III

Dublin, ON

$29.44 - $52.05/hr

... downstream operations Develop and execute transfer strategies, project plans, risk assessments, and readiness activities to support successful process implementation Partner with process development ...

Sanofi EU

Downstream Manager - Night Shift

Mississauga, ON · On-site

CA$76K - CA$110K/yr

Lead operations team execution on the shop floor for equipment, processes, and facilities. Monitor ... Provide individual feedback on staff objectives and development, coaching each team member on ...

Sanofi EU

Downstream Manager - Night Shift

Maple, ON · On-site

CA$76K - CA$110K/yr

Lead operations team execution on the shop floor for equipment, processes, and facilities. Monitor ... Provide individual feedback on staff objectives and development, coaching each team member on ...

Sanofi EU

Downstream Manager - Night Shift

Unionville, ON · On-site

CA$76K - CA$110K/yr

Lead operations team execution on the shop floor for equipment, processes, and facilities. Monitor ... Provide individual feedback on staff objectives and development, coaching each team member on ...

Sanofi EU

Downstream Manager - Night Shift

Toronto, ON · On-site

CA$76K - CA$110K/yr

Lead operations team execution on the shop floor for equipment, processes, and facilities. Monitor ... Provide individual feedback on staff objectives and development, coaching each team member on ...

Sanofi EU

Downstream Manager - Night Shift

Brampton, ON · On-site

CA$76K - CA$110K/yr

Lead operations team execution on the shop floor for equipment, processes, and facilities. Monitor ... Provide individual feedback on staff objectives and development, coaching each team member on ...

FNZ

Business Process Analyst

Toronto, ON

Engage Business Readiness teams to ensure process artefacts support downstream operational ... Experience within anenvironment of continuous improvement and capability development. * Confident ...

Next Generation

MS&T Scientist

Dublin, ON

$60K - $61K/yr

Technical expertise in biologics drug substance upstream and downstream operations, analytical testing, process development, and tech transfer. Ability to work independently and as part of a team in ...

Scotiabank

Manager, Data Engineer

Toronto, ON

Responsible for supporting the end to end data development and enablement lifecycle, including ... downstream reporting and analytics. * Experience supporting production data processes, including ...

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Showing results 1-20

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Downstream Process Development information

What is downstream process development?

A Downstream Process Development job involves optimizing and scaling purification processes for biologics, such as proteins, antibodies, or gene therapies. Scientists and engineers in this role develop efficient methods for isolation, purification, and formulation of therapeutic products while ensuring quality and regulatory compliance. Key activities include chromatography, filtration, and process analytics to improve yield, purity, and consistency. This role is critical in biotech and pharmaceutical industries to ensure safe and effective drug production for clinical and commercial use.

What does someone in downstream process development do?

Professionals in Downstream Process Development are typically responsible for designing, optimizing, and scaling up purification processes for biopharmaceutical products. Their day-to-day work may involve conducting laboratory experiments, analyzing data, troubleshooting technical issues, and documenting process changes in accordance with regulatory standards. They also frequently collaborate with upstream processing, analytical, and quality teams to ensure seamless transfer and integration of processes. The role often includes participating in project meetings, contributing to process validation efforts, and supporting technology transfer to manufacturing teams, making it both technically challenging and collaborative.

What are the key skills and qualifications needed for downstream process development?

To excel in Downstream Process Development, you generally need a strong background in biochemistry, chemical engineering, or a related life sciences field, often with experience in bioprocessing or purification technologies. Familiarity with chromatography systems, filtration equipment, process analytical technology (PAT), and relevant software such as DeltaV or Unicorn is frequently required, along with knowledge of GMP and regulatory standards. Excellent problem-solving, project management, and cross-functional communication skills help professionals succeed in dynamic team environments. These competencies are crucial for developing efficient, scalable purification processes that ensure high product quality and support organizational goals.

Downstream Process Development jobs near you
Infographic showing various Downstream Process Development job openings in Ontario as of August 2026, with employment types broken down into 1% As Needed, 76% Full Time, 21% Part Time, and 2% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution.

Principal Process Development Engineer - Extrusion

Spectrum Plastics Group

On-site

Full-time

Posted 10 days ago

Job description

Position Summary

We are seeking an industry-leading extrusion expert to serve as a Principal Process Development Engineer (PPDE) and Subject Matter Expert (SME) for extrusion technologies across our manufacturing sites. This role will be responsible for establishing and institutionalizing best-in-class process development standards, guidelines, and technical frameworks for a wide range of extrusion processes used in medical device manufacturing.

The ideal candidate will bring deep technical expertise, a track record of innovation, and the ability to elevate organizational capability through knowledge-based process development, standardization, and cross-site collaboration.

Key Responsibilities

Technical Leadership & SME Role

  • Serve as the enterprise-wide technical authority on extrusion processes (e.g., single-lumen, multi-lumen, co-extrusion, and micro-extrusion).
  • Provide expert guidance in solving complex process challenges, including material behavior, tooling design, and process optimization.
  • Lead root cause investigations and corrective actions for critical extrusion-related issues.

Process Development Standards & Frameworks

  • Develop and deploy standardized process development methodologies aligned with scientific/knowledge-based engineering principles.
  • Establish process characterization protocols, DOE, and validation approaches (IQ/OQ/PQ).
  • Create design guidelines for tooling, die design, and downstream equipment integration.
  • Define critical process parameters (CPPs) and control strategies.

Technology Development & Innovation

  • Identify and drive adoption of advanced extrusion technologies, including micro-extrusion and multi-material extrusion.
  • Lead feasibility studies for new materials (e.g., implantable polymers such as PEEK, TPU, PCU).
  • Evaluate and recommend new equipment, automation, and digital process monitoring solutions.

Cross-Functional & Cross-Site Collaboration

  • Partner with Product Development, Operations, Quality, and Application Development teams.
  • Ensure smooth technology transfer from development to production across sites.
  • Standardize best practices across extrusion plants to ensure consistency and scalability.

Capability Building & Mentorship

  • Mentor Process Development Engineers and Technicians in extrusion science and engineering.
  • Develop and deliver training programs and technical documentation.
  • Build organizational competency in extrusion process development and validation.

Quality & Compliance

  • Ensure all processes meet regulatory requirements (FDA, ISO 13485) and internal quality standards.
  • Support validation strategies for Class II and Class III medical device components.
  • Integrate SPC, digital quality systems, and Industry 4.0 tools (IIoT) into extrusion processes.

Education

  • Bachelor’s degree in Plastics Engineering or Polymer Engineering or Mechanical Engineering (M.S, Ph.D. preferred)

Experience

  • 15+ years of hands-on experience in extrusion process development, preferably in medical device manufacturing.
  • Demonstrated expertise in:
    • Micro-extrusion and tight-tolerance tubing
    • Multi-lumen and co-extrusion processes
    • Processing of advanced polymers (e.g., PEEK, TPU)
  • Proven track record of developing and implementing process standards and scalable solutions across multiple sites.

Technical Skills

  • Strong understanding of:
    • Polymer rheology and material science
    • Tooling/die design and flow dynamics
    • Scientific extrusion principles and DOE methodologies
  • Experience with process monitoring, automation, and data analytics tools.

Preferred Qualifications

  • Experience in medical-grade thermoplastic materials.
  • Experience integrating digital manufacturing / IIoT systems into extrusion processes.
  • Experience with additional polymer processing techniques preferred.

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