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Product Quality Scientist
2 months ago
Product Quality Scientist Apex Systems is a large staffing and consulting firm and we are looking for a Product Quality Scientist with experience in Biotech/Pharma Product Lifecycles, Analytical Risk & Impact Assessments, and and a background in both Cellular biology and Analytical QC for one of our biotech clients in Toronto. Client: Biotechnology companyContract/Perm & duration: 12-14 month contractLocation: TorontoThis position will be working 2-3 days onsite per week downtown TorontoThe successful candidate will drive consistent data and quality alignment with the program analytical strategy, coordinating project needs and providing analytical guidance for comparability studies, process characterization, stability, product characterization and release testing strategy and specifications, Critical Quality Attributes (CQA) and Quality Target Product Profiles (QTPP) establishment. The candidate will also be responsible for initiating change control, supporting investigations and performing risk assessments. 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.Responsibilities:Champion product quality for assigned program, supporting a proactive team approach to evaluating the quality of cell seeds, banks, intermediates, drug substance and drug products for cellular therapeutics and all related inputs.Work with project teams to establish alignment on analytical strategies throughout the lifecycle of the product.Collate and analyze data throughout the product lifecycle to support process comparability, and the establishment of specifications for CQA through release and stability testing.Liaise with different departments within TechOps (manufacturing, process development, analytical development, formulations) and across CMC to support assessments of QTPPs, CQAs and analytical methods to evaluate CQAs and monitor process.Implement Phase-appropriate Risk Assessments to support and enable Process Characterization strategy.Support investigations related to product quality and in line with overarching analytical strategy.Initiate change control and perform impact assessments and associated risk assessments.Author and review overarching technical protocols and reports and analytical sections of regulatory documents for submission to Health Authorities/ Regulatory agencies,Track progress of activities supporting the analytical strategy, and their impact to understanding of product quality.Ensure that product quality aligns with regulatory requirements in all regions relevant to the company, in compliance with the Quality Management System.Prepare and present technical information relating to product quality internally and externally.Key Qualifications: Master’s degree in Biological Sciences with Minimum of 9 years of relevant experience, PhD with GMP and analytical experience preferred.Good understanding of Cell Biology and attributes of cellular therapeutic, as well as an in-depth knowledge of the analytical methods being used to define product quality.Good understanding of Quality by Design principles, regulatory guidelines and analytical life cycle management are an asset.Strong preference for experience in the Biotechnology setting, particularly cell therapy, pluripotent stem cells, gene editing.Experience with Good Documentation Practices and working in a cGMP or equivalent environment is preferred.Experience in qualification, validation, transfer, and life cycle management of analytical methods is desirable but not required.Experience with writing technical reports, and regulatory documents presenting data clearly and concisely.Excellent organizational and problem-solving skills, with demonstrated ability to work cross-functionally.Excellent written and oral communication skills, with strong organizational skills and keen attention to detail.Working knowledge of statistics and data trending using statistical programs and software is preferred.Competency in computer skills and familiarity with Microsoft Office (Word, Excel, PowerPoint).
