Quality

Associate Director/Director, Quality Control

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 leader to join the ArsenalBio Technical Operations Quality team. The individual will provide leadership in establishing the Quality Control organization within ArsenalBio and provide technical expertise to the Technical Operations team in overseeing QC/Analytics, supporting analytical technology transfer, 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. This position will report to Vice President of Quality.

What You Will Do:

  • Establish QC strategy for the organization, including QC analytics for raw materials, in-process, and final product, as well as environmental monitoring and microbiology
  • Partner with Analytical Development and ensure analytical methods are implemented and qualified/validated to a phase-appropriate GMP state
  • Ensure establishment of material and product specifications
  • Support QC laboratory design and implementation decisions
  • Provide support for deviations, OOS, change control, investigations, and CAPA
  • Provide support during inspections/audits as a QC subject matter expert
  • Provide support with regulatory submissions (IND/BLA)
  • Establish team priorities to meet overall project targets and time-lines
  • Manage contractors and/or consultants, as needed
  • 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
  • Support vendor qualification and supplier audits
  • Position may require travel, 20 – 25% of the time
  • What You Will Bring:


  • Bachelor’s degree or advanced degree in relevant scientific field or discipline
  • 10+ years of experience in biotechnology/pharmaceutical industry
  • 3+ years proven leadership skills managing a quality control function
  • Strong knowledge of cGMP/ICH/FDA/EMA regulations
  • Prior experience in Quality/Analytics for cell therapy products
  • 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 prioritize deliverable for the overall good of the project
  • Ability to work in cleanroom environments
  • Self-motivated, technically driven, and willing to take on duties out-side of general responsibilities
  • 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.

    Apply     

    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

    Benefits

    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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