Process Development Scientist, GMP Media

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.
Responsibilities   Act as a technical lead and subject‑matter expert 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/preventive 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.
Qualifications   Master’s or bachelor’s degree in a relevant scientific/engineering field with at least five 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.
Salary range: $81,700.00 - $. Additional compensation for eligible positions includes target incentives; actual incentives are based on individual performance.
As an equal opportunity employer, STEMCELL is dedicated to ensuring that every employee feels safe, valued, and respected for who they are. Selection decisions are solely based on job‑related factors.

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