Qc Specialist I (Biotech)

QC Specialist I (BioTech)

Apex Systems is a large staffing and consulting firm and we are looking for a QC Specialist with experience in quality divisions of biotechnology firms with knowledge of PCR/Flowcytometry, Microbiology techniques (cell culture), and cGMP documentation, for one of our biotech clients in Toronto.

Client: Biotechnology company

Contract/Perm & duration: 6-month contract (possibility of extension/conversion)

Location: Toronto

This position will be working 80%+ on-site as lab work is required.

Responsibilities

• Nucleic Acid quantification (Nanodrop)
• Perform human cell culture activities on cell therapy products, as part of an analytical QC team, that may include but not limited to:
• Cell counting (manual and automated) and microscopy
• DdPCR and qPCR
• Plating/imaging assays
• Flow cytometry
• Human Cell passaging, Cryopreservation
• DNA and RNA extraction
• ELISA and Enzymatic Assays

• Ensure that experiments, analytical methods, and data meet the requirements for the intended use of assays, which includes lot release, comparability and/or characterization.
• Present scientific data to colleagues in group meetings, prepare and present internal and external presentations (presentations, posters, publications) as required
• Author and review SOPs, study protocols, reports, and other scientific and quality documents
• Assist in the execution of test transfers of scientifically sound QC test methods to be used for the release and/or characterization of cell therapies.
• Collect and analyze data from various assays, track and trend data and supporting the establishment of specifications for critical quality attributes
• This position requires hands-on laboratory work
• Work with project teams to establish reference standard materials for PSC banks and differentiated cell products to support cell therapy programs.
• Support laboratory investigations to evaluate out-of-specification and atypical results within QC methods, including troubleshooting of invalids and monitoring method performance.
• Assess and help implement new technologies, processes, and methods critical to safety and quality of cell seeds, banks, intermediates, drug substance and drug products for cellular therapeutics and other materials.
• Perform studies to qualify and/or validate QC test methods in a clinical phase-appropriate manner. Identify and determine appropriate ranges of (critical) assay parameters to ensure robust, repeatable, and accurate results.
• Perform additional duties to support the safe and efficient operation of the laboratory, and other duties as assigned

Minimum Requirements

• Ability to work independently in a fast-paced, team-oriented organization.
• Excellent written and oral communication skills, with strong organizational skills and keen attention to detail.
• Experience with Good Documentation Practices and working in a cGMP or equivalent environment is preferred.
• A solid understanding of aseptic techniques and technologies in mammalian cell culture is required.
• Minimum of a Bachelor’s Degree in Biological Sciences or related field with a minimum of 5+ years’ OR preferably Master’s degree with 5+ years’ relevant experience is required.
• Demonstrated flexibility in adjusting to changing priorities and schedules.
• Practical understanding of qualification and/or validation of analytical assays is an asset.
• Preference for experience in the Biotechnology or pharmaceutical industry setting, particularly cell therapy, stem cells, gene editing.
• Occasional weekend work on an as needed basis will be required.
• Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).
• Experience in statistical analysis of data is desired.