WHAT YOU’LL DO
- Lead a team responsible for the development of a GMP process to successfully manufacture T cell therapy products in early and late stages of development, particularly in T cell isolation, activation & expansion, buffer exchange, and automation.
- Oversee and aid team members in the planning, execution, analysis, and reporting 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 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 improve and optimize the cell therapy manufacturing process.
- Manage, train, and mentor direct reports.
- Identify and control process risks using quality tools and process instructions & design.
- Support process engineering team with pre-validation and validation activities.
- Support review of analytical and quality control testing to inform product characteristics.
- Document development activities as source materials for regulatory filings.
- Work closely with analytical scientists to monitor and understand the impact of process changes on impurity clearance profiles and final product CQAs.
- Lead studies with key stakeholders to identify and characterize individual donor attributes which impact 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.
- Devote time to professional development of team members, including seeking out opportunities for growth, development, and career progression.
WHO YOU ARE
- PhD with 7+ years, or Master's with 12+ years, or Bachelor's with 14+ years of experience in a relevant scientific discipline, such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, Biochemistry
- Successful track record of performance and expertise in process development for cell therapies through 5+ years of relevant research experience in T cell biology and/or immunotherapy
- Excellent communication skills and proven track record of managing direct reports, including training, mentoring, and coaching
- Experience in GMP-compatible, clinical-scale human immune cell isolation, T cell activation, and/or mammalian cell culture techniques
- Strong understanding of cGMP environment, Design of Experiment (DOE), and Quality by Design (QBD) principles for process development
- Expertise in multi-color flow cytometry analyses including execution and data analysis
- Demonstrated ability to work well in a highly collaborative team environment and coordinate tasks across multiple projects to meet deadlines.
- 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.
- Non-viral gene editing experience
- Experience working in a GMP environment with Quality oversight
- Experience in T cell functional assays including cytotoxicity, cytokine/chemokine, and proliferation
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What We Do
ArsenalBio is a privately held, programmable cell therapy company focused on the realization of solid tumor cell therapy to defeat cancer. Our discovery engine comprises precise CRISPR-enabled genome editing, integrated circuits incorporating logic gates for improved tumor targeting, and therapeutic enhancements enabling multiple pharmaceutical functions. With our programmable and computationally driven approach, we aim for enhanced and broader efficacy, increased patient safety, reduced provider costs and expanded market access. Our team is engineering living medicines to attack cancer’s inherent multi-faceted nature and bring dramatic improvements to the lives of patients.







