Downstream Process Subject Matter Expert (SME) – Support/Utiliti
Toronto, Canada
PharmEng
Posted on: November 25, 2024
Closing: December 25, 2024
Position Type: Full Time
Job Description
- 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.
Apply
PharmEng
Posted on: November 25, 2024
Closing: December 25, 2024
Position Type: Full Time
Career Focus: Analyst, Project Management, Quality
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