Job Description Summary Are you looking to apply your scientific expertise to lead process development initiatives and drive the advancement of GMP media products? STEMCELL Technologies, Canada’s largest biotechnology company, is seeking a Process Development Scientist to design, develop, and optimize scalable, robust GMP processes for cell culture media. As a Process Development Scientist, you will support the seamless progression of products from initial design through scale-up and technology transfer, ensuring safety, consistency, and quality across the product lifecycle. You will also act as a key subject matter expert, presenting technical information and providing input on cross-departmental and cross-functional project execution. Duties and Responsibilities Act as a technical lead and Subject Matter Expert (SME) in process development of GMP cell culture media products Apply Quality by Design (QbD) principles in designing and executing product and process characterization studies, conducting risk assessments, and identifying process controls and specifications Lead the technology transfer of manufacturing process to the GMP manufacturing team, ensuring process information and controls are accurately captured in GMP manufacturing batch records and associated documentation Lead and/or participate in non-conformance root cause investigations to identify and resolve issues, and provide recommendations on disposition and corrective/preventative actions (CAPA), as required Support GMP product maintenance and GMP process improvement initiatives by providing technical inputs and conducting studies, as appropriate Collaborate across departments with cross-functional teams, presenting technical information, authoring technical reports, and reviewing technical documentation Knowledge and Qualifications Master's or Bachelor’s degree in a relevant scientific/engineering field with at least 5 years of relevant industry experience Advanced technical knowledge in process development, and QbD principles and its practical application Knowledge of industry best practices in experimental design, current good manufacturing practices (cGMP), and regulatory standards as they relate to the biotech/pharmaceutical industry Good understanding of change management, with strong critical thinking and attention to detail Excellent written and verbal communication skills Benefits Competitive salary and comprehensive benefits, including health coverage and retirement savings, along with meaningful career development opportunities. Equal Opportunity Employment STEMCELL is an equal opportunity employer dedicated to ensuring that every employee feels safe, valued, and respected. We nurture an inclusive culture that encourages diverse perspectives and is committed to zero tolerance for discrimination. #J-18808-Ljbffr
Process Development Scientist, Gmp Media
STEMCELL TECHNOLOGIES
burnaby, burnaby
Published 27 days ago
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