Job Description Summary
The Process Development department currently has an opening for a Process Development Scientist in the Cell Culture Media group. The Process Scientist will support optimization of existing Manufacturing processes and investigate non-conformances that have occurred during production. The successful candidate will also have some experience in manufacturing cell culture liquid media and/or demonstrate knowledge of formulation chemistry. The Process Development Scientist will have a strong communication and interpersonal skills and will work cooperatively within Process Development and in cross-functional teams to support the design and execution of manufacturing process changes and process improvements.
Duties and Responsibilities
- Assist in identifying, testing, and implementing new processes and process controls for the manufacture of existing cell culture media products.
- Perform gap analysis using risk management principles, and execute appropriate risk mitigation activities.
- Apply solution chemistry fundamentals and biological knowledge to design and support process characterization studies and to develop control strategies for manufacturing processes.
- Work closely with the Process Engineering team to implement best practices for manufacturing unit operations.
- Prepare process development project proposals and reports, process flow diagrams, production batch records and other documentation.
- Assist in the development, analysis and maintenance of product and raw material categorization databases.
- Present experimental results at data meetings, clearly communicating conclusions and future plans.
- Support process investigations and root cause analysis, and assist in the execution of corrective and preventative actions for process-related non-conformances.
- Work with manufacturing team to implement new processes, including documentation and technical know-how.
- Education and relevant industrial experience in Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering or relevant discipline (PhD with 0-2 years, MSc with minimum 3-5 years, Bachelors with minimum 5-10+ years).
- Excellent verbal and written communication skills as well as strong interpersonal skills is required.
- General knowledge of biological raw materials and cell culture media is an asset.
- Expertise in solution chemistry is an asset.
- Good understanding of scale-up principles and technology transfer is an asset.
- Experience in the conception, design, and optimization of manufacturing processes related to cell culture media products is an asset.
- Experience with experimental design methodologies such as DOE is an asset.
- Hands-on experience in running lab and pilot scale experiments is asset.
- Exposure to ISO 9001, ISO 13485 quality management system and cGMPs is an asset.
- Understanding of the challenges associated with scale-up and technology transfer is an asset.
- Must be self-motivated, proactive, organized and work well within a team.
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.
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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