Scientist I, Analytical Development- Cell-based

7 days ago

Hayward, United States Arsenal Biosciences Full time

**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 talented and experienced Scientist I, Analytical Development (Cell-Based Assays and ELISA) 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 Scientist to join the ArsenalBio Technical Operations team. The individual will work closely with team members to develop analytical test methods and characterization tools in support of our cell therapy products. The individual will also interact cross-functionally across the organization to enable the success of ArsenalBio.
- WHAT YOU’LL DO
- Independently design, test, and implement quality-based analytical assays to support the characterization and release of cell therapy products**.**:

- Develop and qualify cell based assays and ELISA assays
- Actively contribute to the development, and efficient execution of analytical methods for characterization of cell therapy process development, process manufacturing and drug products.
- Plan and execute assays, and analyze data and timely deliver reports
- Serve as an analytical SME to develop and perform in vitro cell-based analytical assays (cytotoxicity, cytokine, proliferation, etc.) for cell therapy product development
- Provide analytical support for clinical-scale IND-enabling manufacturing operationsIncluding: 1) Preparation of test methods, SOPs and technical development reports 2) Assay qualification, provide technical support and tech transfer to Quality Control in supporting of QC assay establishment and GMP lot release
- Provide technical expertise and leadership within Analytical Development teams and in a matrix environment.
- Establish data tracking and trending analyses of process developmental runs and cGMP production runs, including evaluation of critical reagents and lot to lot variability, in order to improve process and assay standardization.
- Good understanding of cGMP environment, and Quality by Design (QBD) principles for assay development, qualification and validation required.
- Collaborate closely with other functions to enable effective and successful project execution; actively engage in cross-functional collaboration with peers to overcome challenges
- Organize, communicate, and present complex data sets to key stakeholders and senior management
- Provide leadership and mentorship to junior Scientists

WHO YOU ARE
- Degree in Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, Biochemistry, or a related discipline with years of relevant experience in industry as stated below for Scientist I: Ph.D. with 0-2 years relevant experience, Masters with 5+ years relevant experience, or Bachelors with 7+ years relevant experience
- Minimum 2+ years of hands-on experience in cell culture, and ELISA.
- Prior experience in T cell biology, cell therapy, industry, analytical development preferred Relevant experience in biopharmaceutical setting, and successful performance track record in establishing, and
- ing analytical assays for cell therapy products.
- Attention to detail, ability to work in a highly adaptive environment and learn new skills for changing priorities
- Demonstrated ability to work in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines
- Flexible and creative, with ability to think outside the box in order to problem solve
- Excellent communications and presentation skills, written and verbal
- Willingness to expand scope of responsibilities outside of initial job description with time
- Understanding of ICH guidelines and quality system regulation is desirable

**BENEFITS AND PAY**
- ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra “Arsenal Days of Rest” every quarter for employees to recharge.Our people-first culture fosters a deep appreciation for humanity, both in the people we endeavor to serve as well as each other. We a

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