Senior Process Development Associate, Technology Transfer
Job Description Summary
The Process Development Department is looking for a highly motivated Senior Associate to join the Media team. The Process Development Media team is responsible for the technology transfer of multiple new GMP and Research Use Only products, while concurrently collaborating to create capacity and maintaining a huge 2000+ cell culture product portfolio.
The Senior Associate will be responsible for the development and optimization of new and existing processes to support manufacturing in the GMP facility. The successful candidate will support the technology transfer of cell culture media products from Research and Development (R&D) to the Manufacturing group, or between manufacturing sites. The Senior associate will work in a dynamic and collaborative team which deals with multiple competing priorities, steers efficiently through prioritization challenges, and has a learning and growth mindset.
Primary responsibilities include developing efficient and scalable manufacturing processes for GMP cell culture media products, developing process control strategies using both risk-based approach and laboratory-based process characterization studies. Good understanding of scale-up principles and technology transfer is an asset, with preference given to candidates with knowledge in biological raw materials and cell culture media.
The ideal candidate will be someone who takes initiative, relishes critical thinking and solving complex problems, enjoys building and nurturing collaborative relationships across departments and takes pleasure in learning continuously.
Duties and Responsibilities
- Support development, scale-up, and technology transfer of processes from R&D to Manufacturing, between manufacturing sites, or externally to CMOs;
- Perform gap analysis using risk management principles, and execute appropriate risk mitigation activities;
- Design process characterization studies and develop process control strategies;
- Set product specifications and process parameter ranges through development batches;
- Work closely with the Process Engineering team to implement best practices for manufacturing unit operations;
- Collaborate with cross-functional stakeholders to determine critical quality attributes, critical process parameters, and critical material attributes;
- Collaborate with the GMP Manufacturing team to detail work instructions in production batch records;
- Prepare process development project proposals and reports, process flow diagrams, batch records, and other documentation;
- Analyze data and present results at departmental and team meetings;
- Support process investigations and root cause analysis, and assist in execution of corrective and preventative actions for process-related non-conformances;
- Bachelor’s or Master’s degree in Biology, Biochemistry, Biotechnology, Chemistry, Chemical or Biomedical Engineering or related discipline with minimum 2 to 4 years of relevant industrial experience;
- Hands-on experience in running lab and pilot scale experiments and equipment is required;
- Excellent verbal and written communication skills as well as strong interpersonal skills is required;
- Capable of working effectively in multidisciplinary teams and delivering complex objectives under aggressive timelines;
- Exposure to ISO 9001, ISO 13485 quality management system and cGMPs is an asset;
- Good understanding of scale-up principles and technology transfer is an asset;
- General knowledge of biological raw materials and cell culture media 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;