Downstream Process Subject Matter Expert (SME) – Support/Utiliti
Toronto, Canada
Job Description
Role Overview: We are looking for an experienced Downstream Process Specialist with expertise in support systems, utilities, and waste management within biologics production. The role involves providing technical guidance on downstream processes, emphasizing utilities and wastewater handling to support production efficiency and sustainability.
Core Responsibilities:
- Lead the development, refinement, and improvement of downstream processes, focusing on support utilities, waste, and wastewater systems.
- Offer specialized support for process scale-up and technology transfers, transitioning downstream operations from development to full-scale production.
- Partner with cross-functional teams (MSAT, Operations, Quality, Engineering) to drive smooth project outcomes.
- Supervise process validation activities related to utilities, waste, and wastewater, ensuring compliance and quality standards.
- Guide team members on best practices and innovative approaches in downstream processing and waste management.
- Coordinate sampling tasks, including labeling, dispensing, and tracking for validation projects.
- Identify non-compliance issues, manage risks, and implement corrective measures.
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Qualifications:
- Advanced degree (Ph.D. or Master's) in fields like Biotechnology, Biochemical Engineering, or Environmental Engineering.
- Significant experience in downstream bioprocessing, particularly in areas such as purification, chromatography, and waste management.
- Proven expertise in downstream process development and optimization within biologics manufacturing.
- Comprehensive understanding of GMP standards and regulatory compliance.
- Strong analytical and troubleshooting skills for complex technical challenges.
- Excellent communication skills and proven ability to work well within diverse teams.
- Willingness to support activities across all shifts and provide coverage for sequential manufacturing processes and other key activities (day shifts, five days per week).
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Preferred Qualifications:
- Experience with single-use systems and various chromatography technologies.
- Understanding of upstream bioprocessing and analytical tools.
- Background in technology transfer and process scale-up.
- Skills in process simulation and modeling.
- Knowledge of environmental standards and wastewater treatment practices.
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Benefits:
- Competitive salary with a comprehensive benefits package.
- Access to development programs and career growth opportunities.
- Chance to work in a state-of-the-art facility with a globally respected organization.
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Career Focus: Analyst, Project Management, Quality
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