What You Will Do

• Plan, execute, analyze, and report on experiments and analytic assays to support the development, process characterization, and process validation of drug product GMP process to manufacture, characterize, and release T cell therapy products
• Define and execute in-process, product, and in-use stability studies
• Develop and implement process improvements (e.g. process closure) to improve robustness, scalability and COGs of cell therapy products
• Compile documentation (protocols, batch records, and study reports) to facilitate transfer of ArsenalBio’s process to manufacturing sites (e.g. CDMO(s), internal manufacturing site(s))
• Support process FMEAs to understand process and product risks
• Support operational start-up and technology transfer activities, including, generation of risk assessments, manufacturing batch records, standard operating procedures (SOPs), and training materials
• Provide on-the-floor manufacturing operations support and participate in RCAs
• Support clinical subteam with closure of drug product-related clinical deviations
• Define, execute, and author process validation study plans and reports
• Establish process monitoring trending
• Collaborate closely with other functions to enable effective and successful project execution
• Actively engage in cross-functional collaboration with peers to overcome technical challenges
• Organize, communicate, and present complex data sets to key stakeholders and senior management
• Assist cross-functional activities including hand-offs to various teams, compiling data, and presenting at project meetings
• Assist in regulatory documentation authoring and/or review

What You Will Bring

• PhD, Masters, or Bachelors in a relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, or Biochemistry)
• 0-2 years experience with PhD or 3+ years with Masters or 5+ years with Bachelors of relevant research experience (cGMP manufacturing, T cell biology and/or immunotherapy preferred)
• Expertise in T cell process development and flow cytometry experience is required
• Understanding of and experience with cGMP environment, Design of Experiment (DOE), and Quality by Design (QBD) principles for process and assay development, qualification, and validation required
• Experience working in cGMP environment in supporting equipment set-up, commissioning, qualification is preferred
• Experience working in cGMP environment and within Quality management systems is required
• Prior experience in cell therapy and/or process development teams preferred
• Experience in multi-color flow cytometry analyses including panel design and data analysis required
• Experience in T cell functional assays including cytotoxicity, cytokine/chemokine, and proliferation a plus
• Ability to quickly adapt and learn new skills for changing research priorities
• Flexible mind with the ability to think outside the box, creative approach to problem-solving
• Demonstrated ability to work well in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines
• Willingness to accept other responsibilities outside of initial job description