ExCellThera is a clinical stage cell and molecular medicine company delivering molecules and bioengineering solutions to expand stem and immune cells for use in novel curative therapies for patients with hematologic malignancies. We are a fast-growing company, currently seeking to fill the full-time, permanent position of Associate Process Development. This position is based in Montreal, Quebec.
Under the supervision of the Director and Associate-Director, the Associate, Process Development will develop manufacturing processes geared towards technology transfer for cell therapy products. This role will participate in existing and new technology evaluation and implementation. The Associate is expected to work autonomously and perform experiments, analyze results and communicate findings through development reports and presentations.
Main responsibilities:
- Participate in the execution of in vitro experiments focused on the development, optimization and characterization of cell therapy manufacturing processes, including the manufacture of stem cells, and other differentiated blood products.
- Participate in hands on process development and process characterization activities, ranging from drafting procedures to execution of laboratory studies and data analysis.
- Perform cell-based characterization assays and analyze ranges for (critical) process parameters to enhance and control product yield and quality.
- Evaluate and implement new methods/technologies, whether for cell manufacturing or process characterization.
- Participate in the execution of in vivo experiments required for preclinical studies.
- Depending on seniority, write protocols (internal SOPs, applicable to methods, processes, equipment and systems), experimental plans and reports.
- Follow and contribute to writing of internal SOPs and experiment plans, applicable to methods, processes, equipment and systems.
- Participate in technology transfer to and from external collaborators when required.
- Support external collaborators when required.
- Perform laboratory duties in a safe and efficient fashion.
- Contribute to the development of scalable and automated cGMP compliant manufacturing processes.
- Document experimental data in a timely and accurate manner.
- Routinely present results of work.
- Demonstrate effective communication and social skills to enable collaborative work.
- Support, based on laboratory experience, writing of risk assessments regarding manufacturing process and quality control method changes.
Requirements:
- College (DEC), Bachelor’s or Master’s degree in biomedical engineering, biological sciences, or similar field.
- Minimum of 1+ (MSC), 3+ (BSc) or 5+ (DEC) years of industry experience in process development and/or manufacturing in the cell and gene therapy, regenerative medicine, or related field.
- Experience in laboratory techniques and methods relevant to cell therapy process development
- Hands-on experience with cell processing technologies is preferred.
- Work experience in highly regulated environments will be considered a major asset.
- Proficiency with relevant software and a range of technical applications (e.g. MS Office, statistical software, data analysis).
Critical to this role are:
- Advanced/expert knowledge in cell culture methods with solid aseptic techniques,
- Significant experience in development and execution of flow cytometry methods, and
- Blood processing/hematopoietic progenitor cell processing procedures.
Considered as assets:
- Practical knowledge of experimental design (e.g., DoE) and statistical data analysis, and
- Proficiency in technical scientific writing.
French/English bilingual candidates are preferred. Proficiency in English, spoken and written will be considered a major asset.
Applications and enquiries: marie-isabelle.roy@xpertyse.