Process Development Scientist
STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as “Scientists Helping Scientists” – standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.
Job Description Summary
The Process Development Scientist will contribute to a multi-disciplinary team to streamline and lead process development and technology transfer of STEMCELL products from Research and Development (R&D) to the Manufacturing group. The Process Development Scientist will be responsible for the design and optimization of new and existing Manufacturing processes and will act as a Process Development lead in corporate project teams. Must possess a strong desire to teach and mentor junior staff and to help build infrastructure for the evolving functions of the Process Development department.
Duties and Responsibilities
Responsible for the design, optimization and implementation of upstream process development and scale-up manufacture for the production of proteins, to include the evaluation of microcarrier technology as a scale-up platform
Lead Upstream Process Development aspects associated with technology transfer from Research and Development to Manufacturing
May be required to assist in the development and scale-up of new and existing protein purification processes
Review and optimize processes and process controls for existing products to improve process yields and reduce costs while maintaining product quality.
Collaborate with other Process Development teams, RnD, Manufacturing, Analytical and Quality to enhance cross-functional transparency and executional success.
Collaborate with RnD and Quality to define critical quality attributes and critical process parameters to set meaningful product specifications, through development batch production, method development and testing.
Work with the Manufacturing team to implement new processes, including documentation and technical know-how.
Work closely with the Process Engineering team to implement best practices for unit operations of the manufacturing process e.g. filtration techniques
Lead root cause investigations and assist in the execution of corrective and preventative actions for process-related non-conformances.
Train and mentor junior staff.
Provide technical input and directions during capital projects from concept through detailed design.
Prepare and review documentation for projects, development and validation studies, and Tech Transfer.
BSc in Biology, Biochemistry, Chemical Engineering, Bioengineering or relevant discipline with minimum 7 years of relevant industrial experience or MSc / PhD with minimum 2 years of relevant industrial experience
Exposure to ISO 13485 quality management system and cGMPs is an asset
Hands-on experience running lab and pilot scale experiments and equipment is required
Experience of cell culture and bioreactor operation is required
Experience of suspension and adherent cell line scale up is an asset
Experience with microcarriers is an asset
General knowledge of cell culture media design and troubleshooting is an asset
Experience in the downstream purification of proteins is an asset
Experience with characterization and assay development of proteins is an asset
Good understanding of the challenges associated with scale-up and technology transfer is an asset
Must have a strong focus on continuous improvement
Must be able to multitask
Effective oral and written communication skills, as well as strong interpersonal skills, are required
Capable of working effectively in multidisciplinary teams and delivering complex objectives under aggressive timelines
Management/supervisory experience is an asset
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities.
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