Scientist II Analytical Development

The Toronto, ON site is seeking a Scientist II to join our Analytical Development team. As a central development resource at the company, the Analytical Development 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, develop and optimize analytical methods to support iPSC cell banking and cell therapy manufacturing processes with a focus on genomic characterization methods.
• 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.
• Act as subject matter experts to plan and execute analytical method transfers with upstream (Research) and downstream (Quality Control) analytical teams; qualify assays as appropriate and provide training and further qualification/validation support as needed.
• Champion evaluating and implementing new technologies and analytical methods to characterize PSC starting materials and differentiated drug substances.
• Analyze experimental data to draw conclusions that support decision making and next steps within and across projects.
• Perform other cellular and/or molecular assays as required.
• 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 AD team.
• Identify and evaluate new technologies and incorporate them into product quality assessments as appropriate.
• Present scientific data to colleagues in group meetings, prepare and present internal and external presentations as required.
• Contribute to preparation of CMC sections of regulatory applications.
• Contribute to building a culture that embraces scientific excellence, integrity, urgency, courage, and community.

Minimum Requirements:

• Degree in biological sciences, or similar with 2+ (PhD) or 11+ (MSc) years or 12+ (BSc) of relevant experience, preferably in an industry environment.
• Significant hands-on experience in developing and optimizing genomic characterization methods, such as droplet digital PCR (ddPCR), whole genome sequencing (WGS), optical genome mapping (OGM), fluorescence in situ hybridization (FISH) and/or SNP arrays.
• Experience in clinical cytogenetics is an asset.
• Hands-on experience in mammalian cell culture is required.
• Strong preference for experience in the Biotechnology setting, particularly cell therapy, pluripotent stem cells, gene editing.
• Experience with automated liquid handlers is an asset.
• 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.
• 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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