Demo

Principal Scientist, Process Development

Arsenal Biosciences
Hayward, CA Full Time
POSTED ON 2/18/2025
AVAILABLE BEFORE 5/18/2025

WHO WE ARE

Arsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We seek a talented and experienced Principal Scientist, Process Development to work onsite based in our Hayward office.

ArsenalBio's mission and purpose are very clear : defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines 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 and 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, which advances therapies for patients who need it most.

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.
  • Preferred Qualifications

  • 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
  • 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 cultivates a deep respect for humanity, not only in those we serve but also in one another. We take pride in being part of a company that values and celebrates diversity-in experiences, ideas, and interests. We are empowered in an environment that embraces unity and inclusivity, fostering a sense of belonging and mutual respect.

    We provide powerful tools to empower our employees to take charge of their career paths and reach their full potential. At ArsenalBio, we believe in investing in our employees' well-being-both professionally and personally-because our people are our most valuable asset. Our essential team members bring exceptional expertise in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software, and other fields to turn the possibilities of tomorrow into the realities of today.

    We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.

    We are an equal opportunity employer and deeply value diversity within our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability.

    The estimated base salary for the preferred primary location of the San Francisco Bay area ranges from $174,000 to $213,200. Salary ranges for other locations may vary. Base pay offered may vary based on job-related knowledge, experience, education, and location. Beyond these considerations, we are committed to pay equity and consider the internal equity of our current employees when making any final offers.

    To all recruitment agencies : ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias or to ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.

    Salary : $174,000 - $213,200

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