Job Description

Scientist - Analytical QC

Apex Systems is a large staffing and consulting firm and we are looking for a Scientist - Analytical QC with experience with assay development (both molecular and cellular), neural and ideally glial cells, PCR (ideally ddPCR), and knowledge of GMP and Significant Statistics and for one of our biotech clients in Toronto.

Client: Biotechnology company

Contract/Perm & duration: 12-month contract

Location: Toronto

This position will be working 5 days onsite per week.

We are seeking a Scientist to join our clients Analytical Technology (AT) team, a pillar of the greater Analytical and Quality Control (AQC) function that is responsible for the introduction of novel assays and technologies to AQC. As a central development resource at the company, the AQC team works closely with research, process development, non-clinical and clinical development, manufacturing and quality teams. The successful candidate will be a key scientific contributor and technical leader as part of the larger Technical Operations organization in a dynamic and progressive team developing industry-leading cell-based analytics to characterize cell therapy products and manufacturing processes.

Responsibilities:

• Design and execute in vitro experiments to assess, develop and optimize novel molecular and cell-based functional to characterize cell therapy products and raw materials
• Ensure that assays meet requirements for the intended use of the assays, which includes characterization, lot release, stability and comparability testing of development and manufacturing batches and establish phase-appropriate specifications
• Analyze experimental data to draw conclusions that support decision making and next steps within and across projects
• Perform other biochemical, cellular, and/or molecular assays as required
• Qualify assays as appropriate and provide training and further qualification/validation support as needed
• Prepare and present project plans and regular project progress updates and recommendations
• Document experimental data in electronic laboratory notebooks in a timely and accurate manner in accordance with the company quality management system
• Prepare, review, and approve experimental protocols, reports, standard operating procedures and other scientific and quality documents
• Requires hands-on laboratory work in addition to training and supervision of junior staff members in supporting analytical activities within the AQC team
• Identify and evaluate new technologies
• Present scientific data to colleagues in group meetings, prepare and present internal and external presentations as required
• Contribute to building a culture that embraces scientific excellence, integrity, urgency, courage and community

Key Qualifications:

• Advanced (PhD or MSc) degree in biological sciences, or similar with 1+ (PhD) or 9+ (MSc) years of relevant experience, preferably in an industry environment
• Significant hands-on experience in developing, optimizing and qualifying cell-based activity/potency assays using image-based and biochemical readouts (eg. Incucyte, western blot, immunoassays, enzymatic activity assays, etc.) according to industry and best practice standards is required
• Significant hands-on experience in developing, optimizing and qualifying molecular assays (eg. qPCR, ddPCR, etc) according to industry and best practice standards is required
• Extensive hands-on experience in mammalian cell culture and cell characterization experience is required
• Practical knowledge of statistical analysis of data is required
• Knowledge and understanding of statistical programming languages (R, python, etc.) and Design of Experiments (DoEs) is preferred
• Experience culturing and characterizing neuronal and glia cell types is an asset
• Proven ability to structure, plan, and execute experiments and independently execute complex tasks in a fast-paced environment
• Excellent organizational and problem-solving skills, with demonstrated ability to work cross-functionally
• Proficiency in technical scientific writing
• Excellent interpersonal, verbal and written communication skills
• Experience with GxP guidelines/documentation and general GxP experience in analytical development is an asset but not required

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