Process Development Scientist
Are you looking for a way to have a broad and immediate impact on the scientific community? Want to work for an international, fast-paced, growing company that supports the advancement of health sciences research globally?
The Process Development Department is looking for a highly motivated Scientist in the Media team.
The Media team is responsible for technology transfer of GMP and Research Use Only (RUO) products, while creating capacity and maintaining a large portfolio of STEMCELLs products. The team successfully tech-transferred 5 new GMP and 40 new Research Use Only (RUO) products in the last fiscal year, while concurrently collaborating to create capacity and maintain a huge 2000+ cell culture product portfolio. The Scientist will work in a dynamic and collaborative team which deals with multiple competing priorities, steers efficiently through prioritization challenges, and a strong learning and growth mindset.
The Scientist will be accountable for:
Optimization of existing manufacturing processes for the purpose of cost savings, improving efficiency and generating manufacturing capacity.
Maintaining a large media product portfolio of 2000+ products by supporting non-conformance investigations and corrective or preventive actions (CAPAs).
Duties and Responsibilities
- Apply solution chemistry fundamentals and biological knowledge to design and support process characterization studies and to develop control strategies for manufacturing processes.
- 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.
- Work closely with the Process Engineering and Manufacturing teams to implement best practices for manufacturing unit operations, including documentation and technical know-how.
- 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.
- Education and relevant industrial experience in Solution Chemistry, 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).
- Effective oral and written communication skills as well as strong interpersonal skills are required.
- General knowledge of biological raw materials, cell culture and cell culture media is an asset.
- Good understanding of scale-up principles and technology transfer is an asset.
- Exposure to ISO 9001, ISO 13485 quality management system and cGMPs is an asset.
- Experience of DoE, statistical approach, and Quality by Design (QbD) is an asset.
- Experience in the conception, design, and optimization of manufacturing processes related to cell culture media products is an asset.