Senior Quality Engineer I (2266-N-682-QA)

ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer.  Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments. 

Our people 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 seeking a talented and motivated Senior Quality Engineer to join the ArsenalBio Technical Operations team. The individual will support ongoing Quality Engineering initiatives and provide technical expertise to other Technical Operations teams. The primary responsibilities will be to support activities focused on establishing ArsenalBio capability to perform clinical product manufacturing of cell therapy products. These activities include Commissioning and Qualification of equipment / utilities / facility, Computerized System Validation, and Risk Management. The individual will work closely with Manufacturing, Quality Control, Facilities & Engineering, Materials Management, and Information Technology to enable the success of ArsenalBio’s clinical scale manufacturing process. This position will report to Head of Quality Engineering.

What You Will Do:

  • Partner with Manufacturing and Process Development groups to determine phase appropriate commissioning, qualification, and validation strategies
  • Review and approve C&Q documentation for technical soundness and compliance
  • Provide oversight for C&Q related activities
  • Author, review, and/or approve process validation lifecycle documents
  • Participate in Risk Assessments and facilitate as needed
  • Promote a Quality mindset and continuous improvement
  • Participate in internal and external inspections / audits 
  • This position may require some travel, as needed

  • What Will You Bring:

  • Bachelors in relevant scientific field or discipline
  • 8+ years of experience in biotechnology/pharmaceutical industry
  • Strong knowledge of cGMP/ICH/FDA/EMA regulations
  • In depth knowledge of QE principles, concepts, industry practices, and standards
  • Strong technical writing and verbal communication skills
  • Strong critical thinking and problem-solving skills
  • Ability to work in cleanroom environments
  • Self-motivated, technically driven, and willing to take on duties outside of general responsibilities

  • ArsenalBio prioritizes the providing of a safe and healthy workplace that is consistent with COVID-19 public health guidance and legal requirements.  In order to protect our employees and visitors, we require all visitors (including candidates) and employees to present proof of being fully vaccinated against COVID-19 when coming onsite.

    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.

    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.


    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.

    Ken Drazan, MD
    Founding CEO


    Best in Class Health & Wellness Plans

    Flexible Office Hours

    Paid Parental Leave

    Healthy Kitchen Snacks

    Daily Catered Lunches

    Free Onsite Fitness Center

    Unlimited Vacation Days

    Generous compensation and equity packages

    Commuter Benefits

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