WHO WE ARE Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a motivated and talented intern to join the ArsenalBio Process Engineering team. This role is an onsite position located at 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. The successful candidate will work closely with cross-functional team members to develop and optimize phase-appropriate, GMP-compatible manufacturing processes and procedures for our clinical stage cell therapy products. This individual will be responsible for  the execution and documentation of Drug Product (DP) process characterization studies (e.g. fill volume range finding, post-thaw stability evaluations, thaw recovery assessments) as well as preparation of data sets that will ultimately contribute to regulatory filings. This position will report into a Senior Process Engineer within the Process Engineering team, and will also interact cross-functionally within Process Sciences (e.g. Process Development, 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

Execute in-process, product, and in-use T cell stability studies using various candidate drug product container configurations to enable various clinical dose levels

Execute cryopreservation characterization studies to optimize thermal load distribution and ensure product stability during crucial cryopreservation unit operations

Evaluate secondary and tertiary Drug Product container configurations to develop and optimize end-to-end drug product transportation and delivery strategy

Collaborate closely with other functions to enable effective and successful project execution

Actively engage in cross-functional collaboration with peers

Organize, communicate, and present data to key stakeholders

Assist cross-functional activities including hand-offs to various teams, compiling data, and presenting at technical meetings

Opportunity to gain experience working in an industry BSL 2 lab environment with specialized cell therapy processing equipment 

Opportunity to learn about and execute flow cytometry assays to characterize cell product quality prior to and after cryopreservation

Opportunity to gain familiarity with the drug product development lifecycle and clinical trial design and execution from a trial sponsor perspective

Opportunity to learn about GMP process design principles and use of engineering and process controls in order to maintain drug product quality

Opportunity to learn about and provide input on logistical considerations for shipping drug product to trial centers while introducing sufficient controls to ensure product quality 

WHO YOU ARE

Current 3rd or 4th year undergraduate student enrolled in a Bachelors degree program studying Biology, Biochemistry and Molecular Biology, Immunology, or similarly relevant degree program

Experience working in a biological laboratory setting with basic lab techniques (e.g. use of PPE, pipetting, centrifuge balancing, lab notebook documentation, aseptic technique) is required

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

Experience with human immune cell isolation, T cell expansion, and mammalian cell culture techniques is desirable

Knowledge of cell therapy and/or gene therapy is desirable

Experience with data visualization software (e.g. JMP, Prism, Tableau) is a plus

Familiarity with/knowledge of biological assays (PCR, Flow Cytometry, Cytokine ELISA) is a plus