Senior Research Associate II, Process Development (25022-B-680-PS)

WHAT YOU’LL DO

• Work collaboratively within a team responsible for development of a GMP process to successfully manufacture T cell therapy products in early and late stage development, with a focus on isolation, activation, buffer exchange, and automation.
• Independently plan, execute, analyze, and report on experiments to support development of unit operations.
• Author and compile documentation (protocols and study reports) to facilitate transfer of Arsenal Biosciences’s process to GMP manufacturing.
• Organize, communicate, and present complex data sets to key stakeholders and senior management.
• Actively engage in cross-functional collaboration to enable effective project execution and overcome challenges.
• Explore and evaluate emerging technologies to optimize the cell therapy manufacturing process and improve product understanding.
• Document development activities as source materials for regulatory filings.
• Work closely with analytical scientists and research groups to monitor and understand the impact of process changes on final product CQAs.
• Support tech transfer to internal manufacturing or CMOs. 
• Understand and keep-up with the Intellectual Property (IP) landscape around process technologies and biologic products.
• Maintain a leadership presence and awareness that seeks to demonstrate behaviors consistent with ArsenalBio’s values and motivates people to perform to the best of their abilities.

WHO YOU ARE

• Master’s + 2 years or Bachelor’s + 4 years of experience in a relevant scientific discipline such as Biotechnology, Bioprocess/Biochemical Engineering, Immunology, Molecular Biology, Biochemistry).
• Experience with GMP-compatible, clinical-scale human immune cell operations and/or mammalian cell culture techniques.
• Experience in multi-color flow cytometry analysis including execution and data analysis.
• Creative approach to problem-solving and ability to think outside the box.
• Willingness to accept responsibilities outside of initial job description and quickly adapt in response to changing company priorities.
• Authenticity, enthusiasm, and a team-first attitude.


Preferred Qualifications: 
• Understanding of cGMP environment, Design of Experiment (DOE), and Quality by Design (QBD) principles for process development.
• Hands-on experience with automated cell isolation & washing and concentration systems.
• Experience working in a GMP environment with Quality oversight.
• Experience in T cell functional assays including cytotoxicity, cytokine/chemokine, and proliferation.