Senior Research Associate

Role Summary

Senior Research Associate focusing on optimization of process and product quality for cell therapy engineering and manufacturing, with a emphasis on enabling next-generation CAR T-cell therapies for solid tumors and hematologic malignancies.

Responsibilities

• Execute experiments to optimize process and product quality parameters, enhance cell therapy engineering and manufacturing capacity, apply Quality by Design (QbD) principles and Design of Experiment (DoE) methodologies, where appropriate
• Support cross-functional collaborations/projects with research, analytical and manufacturing stakeholders
• Collaborate with internal and external partners to evaluate new process technologies to develop next generation processes
• Work effectively in a team environment as well as contributing individually to meet project timelines and deliverables
• Support authorship of technical reports, regulatory documents and summaries of experiments and investigations
• Participate in authorship and review of batch records and SOPs
• Assist in the execution of comparability packages supporting the implementation of process changes

Qualifications

• BSc in Biology, Immunology, Biotechnology, Bioengineering, or related field with a minimum of 7 years’ experience within the area of focus; or
• MSc in Biology, Immunology, Biotechnology, Bioengineering or related field with a minimum of 5 years’ experience within the area of focus
• Demonstrated experience with scale-up and optimization of bioreactors for cell-based therapies
• Proven experience in GMP manufacturing setting, technology transfer and implementation of new technologies in a regulated environment (GMP, GLP, GxP)
• Experience with the assessment of new technologies, preferably in a cross-functional setting where impact of new technologies is evaluated across research, development and commercial organizations
• Demonstrated cell therapy experience
• Experience with scale-down model implementation and process characterization

Knowledge, Skills and Abilities

• Understands the theoretical basis and experimental objectives and how they fit into the overall project and broader company goals; can give input based on literature knowledge to drive the direction of the project
• Highly proficient in using Microsoft Office (Word, Excel, PowerPoint) and data analysis software packages (Prism, Flow Jo, Spotfire, Geneious, etc)
• Effectively communicate, collaborate and discuss results with other scientists on the team
• Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities
• Excellent analytical skills and scientific/technical expertise
• Strong ability to work in a matrixed environment