Analytical Scientist I/II

Job Description

<p><b>Analytical Scientist I / II</b></p><p><br></p><p><b>Client: </b>Biotechnology company</p><p><b>Contract/Perm & duration</b>: 12-month contract (possibility of extension/conversion)</p><p><b>Location</b>: Toronto, Hybrid (1-3 days)</p><p><b>Pay Rate: </b>$40-60/ hr (T4)</p><p><br></p><p><b>Description of Position</b></p><p><br></p><p>Our biotech client is looking for a Scientist, specialized in cellular and molecular biology, to support a dynamic and progressive Analytical and Quality Control team (A&QC). The position requires a data driven scientist with an analytical mindset who has great communication skills and will thrive in a cross-functional team environment. Familiarity with work under GLP or GMP regulations is a must.</p><p>Reporting to the Associate Director within the Analytical Strategy & Execution (AS&E) team, the Scientist will be a key analytical contributor of the ASE team establishing the analytical strategy, life-cycle improvements, and control strategies to progress clinical programs to commercial readiness, for the final differentiated cell therapy dose.</p><p><br></p><p>The successful candidate will drive consistent analytics, data and quality alignments within the program analytical strategy, coordinating analytical deliverables and providing analytical assessments for Quality Target Product Profiles (QTPP), Critical Quality Attributes (CQA), release testing strategy and specifications and product characterization. The candidate will facilitate appropriate method implementation strategies in a GMP compliant manner and drive the design and execution of studies in support of product understanding, such as, but not limited to, stability, dose assurance, and comparability. The ideal candidate will be highly motivated and able to lead by example in technically complex scientific discussions, solving a wide range of challenging problems in creative and practical ways with a collaborative approach across a matrix of functional groups. </p><p><br></p><p><b>Responsibilities</b></p><p><br></p><ul><li>Champion product quality, supporting a proactive team approach to analytical evaluation of the quality of cellular therapeutics, all related inputs and impacts of associated device.</li><li>Work with project teams and different departments across CMC to establish alignment on analytical strategies throughout the lifecycle of the product. Track progress of activities supporting the analytical strategy and assess impact to understanding of product quality.</li><li>Drive scientific coordination of analytical studies to further product understanding, establishing study design, protocol writing, experimental planning, logistical coordination, internal/external partner management, data analysis and report writing, and collaboration with local sites for execution. </li><li>Evaluate, implement and/or transfer novel technologies, processes and methods, as required, to facilitate testing of therapeutic cell products and associated materials, with the appropriate level of compliance for clinical application.</li><li>Support assessments of QTPPs, CQAs, testing strategy and analytical methods to evaluate attributes and monitor process. Collate, analyze and trend data from various assays throughout the product lifecycle to establish target criteria and specifications and assess product characteristics. </li><li>Ensure that product quality, analytical methods and data align with regulatory requirements in all regions relevant to the company, in compliance with the Quality Management System. Author and review overarching technical protocols and reports and analytical sections of regulatory documents for submission to Health Authorities/ Regulatory agencies.</li><li>Prepare and present scientific and technical information relating to product quality, analytical strategies and/or executed studies internally and externally. Author and review SOPs, reports and other scientific and quality documents.</li></ul><p><br></p><p><b>Minimum Requirements</b></p><ul><li>PhD or equivalent in Biological Sciences or related field plus 1 year of relevant experience or Master's degree in Biological Sciences with minimum of 9 years of relevant experience or Bachelor's degree in Biological Sciences with minimum of 10 years of relevant experience.</li><li>Good understanding of Cell Biology and attributes of cellular therapeutics is required, where working knowledge of Quality by Design principles, regulatory guidelines and analytical life cycle management are an asset. </li><li>Extensive experience with analytical technologies and cell characterization methods used to define product quality, such as imaging, cell-based assays, molecular techniques, flow cytometry, functional assays, mammalian cell culture and/or microbial safety is required.</li><li>Strong preference for experience in the Biotechnology setting, particularly cell therapy, pluripotent stem cells, gene editing.</li><li>Experience with Good Documentation Practices and working in a cGMP or equivalent environment is required.</li><li>Experience in qualification, validation, transfer, and life cycle management of analytical methods is preferred.</li><li>Experience with writing technical reports, and regulatory documents presenting data clearly and concisely. </li><li>Excellent organizational and problem-solving skills, with demonstrated ability to work cross-functionally.</li><li>Excellent written and oral communication skills, with strong organizational skills and keen attention to detail.</li><li>Working knowledge of statistics and data trending using statistical programs and software is desirable. </li><li>Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).</li></ul><p></p>