Senior Process Engineer I (24115-R-680-PS)

WHO WE AREArsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Principal Quality Control Specialist to work onsite based in our Hayward office. 
ArsenalBio’s mission and purpose is very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines with the goal to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.
Driven by a collective of diverse experts across multi-scientific disciplines as well as clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients’ lives.
This means you’ll have the opportunity to work with the best talent in the field of cell therapy, and be part of ONE TEAM advancing therapies for patients who need it most.
We are seeking a talented and motivated Process Engineer to join the ArsenalBio Process Engineering team. The individual will work closely with cross-functional team members to develop, optimize, transfer processes for GMP manufacturing. They will work closely with Manufacturing Operations, MSAT, and Quality groups to provide manufacturing troubleshooting support, to participate in root cause analyses (RCAs), to perform and document risk/impact assessments and RCAs, and to author change control documents as needed. Additionally, this individual will be responsible for identifying, evaluating, and transferring improvements for drug substance (DS) and drug product (DP) manufacturing processes; and the execution and documentation of DS and DP process characterization and validation studies for later-stage projects and regulatory filings. This position will report into the Process Engineering team lead, and will also interact cross-functionally within Process Sciences (e.g. Analytical Development), Tech Ops (e.g. Manufacturing, Supply Chain, Quality), and across the organization (e.g. Clinical Subteam) to enable the success of ArsenalBio.

WHAT YOU’LL 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
• Define, execute, and author process characterization/validation study plans and reports
• Collaborate closely with other functions to enable effective and successful project execution including 1) Actively engage in cross-functional collaboration with peers to overcome technical challenges, and 2) Assist cross-functional activities including hand-offs to various teams, compiling data, and presenting at project meetings
• Organize, communicate, and present complex data sets to key stakeholders and senior management
• Assist in regulatory documentation authoring and/or review

WHO YOU ARE

• PhD, Masters, or Bachelors in a relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, or Biochemistry)
• PhD or Masters with 3+ years or Bachelors with 5+ years  relevant research experience (cGMP manufacturing, T cell biology and/or immunotherapy preferred)Expertise in T cell process development and flow cytometry
• Experience in multi-color flow cytometry analyses including panel design and data analysis 
• Experience in T cell functional assays including cytotoxicity, cytokine/chemokine, and proliferation is a plus
• Understanding of and experience with cGMP environment, Design of Experiment (DOE), and Quality by Design (QBD) principles for process development, qualification, and validation
• Experience working in cGMP environment in supporting equipment set-up, commissioning, qualification is preferred
• Experience working in cGMP environment and within Quality management systems
• Prior experience in cell therapy and/or process development team is a plus
• Ability to quickly adapt and learn new skills for changing research priorities
• Flexible m