Development

Turning our discoveries into life-saving medicines.

Developing safe and effective therapies requires innovation, discipline, and commitment to the highest standard of quality and ethics. By bringing together novel discoveries into new medicines you will help deliver on the full promise of cell therapy to cure disease.

Together, we will transform the potential of cell therapy into a practical reality.

Quality Manager/Scientist (Process Development and Technology Operations)

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 Manager to join the ArsenalBio Process Development and Technology Operations (PDTO) team to establish and perform Quality review and oversee functions at Contract and Development Manufacturing Organizations (CDMOs) and Contract Testing Labs (CTLs). The individual will support ArsenalBio’s manufacturing process for clinical trial material production, testing, release of clinical material, and be instrumental in developing the framework of product quality oversight and infrastructure. The individual will work closely with team members to develop Quality infrastructure. The position will report to the Director of Process Development and Technology Operations. The individual will also interact cross-functionally across the organization to enable ArsenalBio’s success.

What You Will Do

  • Manage and review batch records, protocols, lot release testing, stability, clinical handling studies, and method validations studies performed at external vendors and coordinate with internal groups
  • Set ArsenalBio’s quality expectations and manage the CMO Quality infrastructure and release process (e.g. SOPs, batch records, specifications approval) necessary for the oversight of ArsenalBio’s  external supply chain
  • Support development of stability programs and specifications including a proposal of product-specific analytics and acceptance criteria justifications
  • Partner with PDTO in the transfer of manufacturing process and analytical methods to ArsenalBio’s CDMO and CTLs
  • Work with direct line management to identify areas of process improvements and contribute to the development of new concepts, techniques, and standards
  • Collaborate with PDTO to manage assay lifecycle, create assay and process capability trending programs, and define system suitability criteria
  • Represent Quality on project teams and in other cross-functional programs
  • Create and manage programs for the characterization and qualification of reference materials, assay controls, QC cell banks, and critical reagents
  • Resolve contract laboratory and contract manufacturing deviations, OOS/OOT and lab investigations, CAPAs, and product-related change controls
  • Review and approve Quality SOPs, policies, batch records, analytical test methods, protocols, and reports, as needed
  • Support Quality audits and technical visits
  • What You Will Bring

  • MS or BS in relevant scientific field or discipline, 6+ years experience (3+ years experience in a management function) and strong scientific background in Quality Control and Quality Assurance in the drug development industry with strong knowledge of cGMP/ICH/FDA/EMA regulations
  • Prior experience in Quality Assurance for cell therapy products as well as oversight of Quality at contract organizations highly preferred
  • Successful experience writing and reviewing SOPs and other Quality documents
  • Direct experience with quality investigations, assessments, reviews and/or evaluations of Quality events (CAPAs, deviations, change control, document control, etc.)
  • Team player with the ability to work in a collaborative, fast-paced team environment
  • Strong written and verbal communication skills and experience with working in cross-functional teams
  • Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutions
  • Excellent problem-solving skills and experience with root cause investigations and CAPA determination
  • Ability to lead successfully within extended project teams and handle multiple challenges under pressure
  • Excellent communications and presentation skills, written and verbal
  • Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
  • Willingness to travel
  • 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.

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    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