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Principal Quality Control Specialist

Principal Quality Control Specialist

ArsenalBio, a privately held, clinical-stage programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Principal Quality Control Analyst to work onsite based in our Hayward office.

ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. With our programmable and computationally driven approach, our team is engineering living medicines to attack cancer’s inherent multi-faceted nature and overcome the challenges of addressing solid tumors with cell therapy.

Driven by a collective of diverse experts across immunology, synthetic biology, molecular biology, automation and computational biology, we are united in purpose to deliver radical breakthroughs for people with cancer and prioritize the team’s outcomes over individual goals to achieve our company mission – together. 

We are seeking a talented and motivated leader to join the ArsenalBio Technical Operations Quality team. The individual will provide technical expertise and leadership to the Technical Operations team in overseeing QC/Analytics, and clinical product testing of cell therapy products. The individual will work closely with Quality Operations, Process Development, Analytical Development, and Manufacturing to enable the success of ArsenalBio’s clinical scale manufacturing process. The position reports to the Head of Quality Control.

What You Will Do:

  • Perform technical review of all analytical testing associated with the batch release, stability and product characterization
  • Be a Subject Matter Expert (SME) for the QC assays especially cell-based potency assay
  • Support QC testing activities as needed 
  • Lead and oversee method transfer activities
  • Perform QC analysis and analyze results for GMP cell therapy products
  • Assist with Contract Testing Lab management
  • Interact effectively with cross functional teams to communicate and resolve testing related issues 
  • Establish team priorities to meet overall project targets and timelines
  • Manages employees, contractors and/or consultants, as needed 
  • Lead/initiate change controls, investigations, and deviations
  • Assists other analysts with impact assessments and root cause analysis
  • Provide support with regulatory submissions (IND/BLA)
  • Provide additional support to other functions, including Quality Operations and QMS, as requested by management, to support project milestones.
  • Promote continuous improvement using Lean and Six Sigma principles.

    • What You Will Bring:

  • Bachelor’s degree in a relevant scientific field or discipline and 10+ years of experience in biotechnology/pharmaceutical industry, advanced degree preferred
  • Prior experience working in a GMP analytical laboratory with demonstrated proficiency in cell culture and cell-based potency assays
  • Experience with various analytical techniques used in Quality Control Labs including cell culture, bioassays, cytotoxicity and ELISA methods
  • Understanding of compliance requirements as it relates to potency assay qualification.
  • Prior experience in Quality/Analytics for cell therapy products 
  • Strong technical writing and verbal communication skills
  • Strong critical thinking and problem-solving skills with experience in Root Cause Analysis
  • Self-motivated, technically driven, and willing to take on duties out-side of general responsibilities

    • What We Will Offer You:
    An opportunity to work with the best talent in the field of cell therapy and be part of ONE TEAM to advance therapies to patients who need it most.

    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.

    We have a robust mentorship program, and comprehensive development tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as they are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

    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 value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

    The estimated base salary offer for the preferred primary location of San Francisco Bay area ranges from $127,300 - $156,000. Salary ranges for other locations may vary from this range.   Base pay offered may vary depending on job related knowledge, experience, education, and location.  In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.

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


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    Bold ideas. Reliable data. World-Class Science.

    Designing therapies to cure our most important health challenges requires the audacity to advance a bold idea and explore new biologies with world-class science.

    By pushing at the frontiers of science, challenging what we think we know, and holding ourselves to the highest standards of irrefutable proof, we are reshaping the future of curative cellular therapies.

    Benefits

    ArsenalBio is powered by people.

    And we believe that people work best when given freedom and flexibility in a supportive environment that allows us all to show up as our true selves. We respect that your life extends beyond the work we’ll do here together, and we continually strive to provide you with what you need to care for yourself and your family.

    Health & Wellness

    We offer comprehensive plans that cover medical, dental, vision, and wellness needs, paid at 100% for employees and 80% for eligible dependents. We also encourage and enable our team to enjoy an active lifestyle so we offer standing desks, daily catered lunches, unlimited healthy snacks, and an employer-funded Lifestyle Spending Account that can be used for fitness and wellness expenses. We also provide access to Spring Health, a platform designed to provide easy access to coaching and therapy services to support your mental well-being.

    Financial Well-Being

    We recognize that financial stability fosters peace of mind for our team and their families. We offer a 401(k) employer match, health savings account employer contributions, flexible spending accounts and company-paid life and AD&D insurance in addition to our generous compensation packages. Our team also enjoys free parking, pre-tax commuter benefits for using mass transit and parking, and monthly cell phone reimbursement.

    Time Off

    We want you to enjoy life. We prioritize work-life integration and offer a flexible time off policy, paid holidays and company shutdowns, flexible office hours, a paid leave program, and the permission to manage your time in a way that allows you to meet both your personal and professional responsibilities.

    Mindful Workspace

    Our new offices were thoughtfully designed with the humans of ArsenalBio in mind. With ergonomically-friendly furniture, an open workspace and state-of-the-art lab with inspiring views, collaborative break-out spaces, wellness rooms, micro-kitchens stocked with healthy snacks, and more, our office reflects our holistic commitment to health and happiness.

    ArsenalBio was formed by its investors and scientific founders to discover, develop and commercialize curative and safe cellular therapies for patients with life threatening diseases, initially cancer.

    We believe the most productive and secure route to achieving this goal is to build scaled platforms of technologies challenged with scientific questions to yield informative data from hypothesis driven, well controlled experiments. These data will inform the design of ambitious, best-in-class, lead compositions. Our leads will be rigorously evaluated and honed until we are convinced our matured leads, called development candidates, can be prepared for testing in needy, and vulnerable patients.

    Our products will be designed to speed the transition of cell therapy from hospital-based to outpatient treatments, increasing access to more patients at lower cost to patients, health systems, and insurers.

    To achieve this mission, we are building diverse teams of talented, curious, and caring individuals who believe in our mission and our vision to be sustainable in our business plan, our work habits, and our personal lives.

    Our values create: a foundation for mutual respect, an engaging harmony from many voices, and unselfish behavior to aid our colleagues.

    This is ArsenalBio.
    This is our Company.