Introduction
Our client is a leading Canadian public research organization that develops innovative biologics and vaccines to improve the health of people in Canada and around the world, offering a highly collaborative, mission-driven environment with excellent stability and benefits.
As a Downstream Processing (DSP) Technician, you will support the manufacture of clinical biologics in a cGMP environment. You’ll be involved in downstream pre-viral steps (elution, clarification, nanofiltration) and post-viral steps (concentration and bulk filling) for clinical-scale batches, ensuring products are manufactured, handled, and documented according to regulatory and internal quality standards.
Responsibilities
- Execute downstream manufacturing steps according to approved batch records and cGMP requirements.
- Prepare and review SOPs, working formulas, and related production documentation.
- Perform in-process assays using equipment such as filter integrity testers, pH meters, and analytical balances.
- Weigh, transfer, and mix chemicals and solutions as required for DSP activities.
- Perform product filtrations, nanofiltration steps, and bulk filling operations for clinical batches.
- Prepare glassware and single-use assemblies and install them on the appropriate purification equipment.
- Verify instrument calibration prior to production and document checks in accordance with procedures.
- Transfer filled bulk containers to designated cold storage (e.g., refrigerators) and complete associated records.
- Review and correct logbooks and other production records to ensure data integrity and completeness.
- Support cleaning activities in collaboration with production support team members.
- Develop autoclave loads with the department manager and ensure compliant sterilization cycles.
- Monitor stock levels of common laboratory and production supplies and flag replenishment needs.
- Respond appropriately to emergency notifications, following site procedures and training.
- Participate in quality system activities such as CAPAs, Change Controls, and Deviation Reports, as applicable.
- Perform other related duties as required to support production and continuous improvement.
Requirements
- Diploma or Bachelor’s degree in Biotechnology, Biochemistry, Chemistry, Pharmaceutical Sciences, or related field.
- Experience in GMP biologics, pharmaceutical, or sterile manufacturing (downstream processing experience is a strong asset).
- Hands-on experience with filtration, clarification, and/or bulk filling operations, preferably in a clinical or commercial setting.
- Comfortable working with SOPs, batch records, and logbooks, with strong attention to detail and documentation accuracy.
- Familiarity with basic laboratory and production equipment (pH meters, balances, filtration systems, single-use assemblies, etc.).
- Ability to follow detailed procedures, work within a highly regulated environment, and meet production timelines.
- Strong teamwork, communication, and problem-solving skills.
- Willingness to work on-site in a cleanroom/GMP environment; flexibility for occasional off-hours or weekend work to support production is an asset.
What We Offer
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About Us
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