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.

Vice President, Head of Quality

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 Vice President, Head of Quality to establish our Quality (Quality Assurance and Quality Control) team. The VP of Quality will be responsible for establishing and managing internal and external Quality operations. This will include establishment of a Quality organization that supports the development and launch of our products. This includes leading the establishment of a Document management/Quality Management System (QMS)/training of personnel and oversight of functions at Contract and Development Manufacturing Organizations (CDMOs) and Contract Testing Labs (CTLs). The individual will support and partner with ArsenalBio’s Process Development and Technical Operations team in overseeing process and analytical technology transfer for clinical trial material production, testing, and release of clinical material and be instrumental in developing the framework of product quality oversight and infrastructure. The role requires the ability to rapidly understand and process complex technical issues from a product quality perspective to develop and implement risk-based solutions. The candidate must be skilled at operating within a matrixed organization, with active collaboration and communication to build consensus in a cross-functional and multi-disciplinary culture. The position will report to the Senior Vice President and Head of Technical Operations. The position requires a strong knowledge of cGMP/ICH/FDA/EU regulations as well as people management and team leadership skills.

What You Will Do

  • Develop and establish a departmental vision, strategy, and structure for Quality at ArsenalBio. 
  • Develop 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
  • Provide high-level support of stability programs and specifications 
  • Partner with PDTO in the transfer of manufacturing process and analytical methods to ArsenalBio’s CDMO and CTLs
  • 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
  • Provide strong leadership in resolving 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
  • Author and/or review CMC sections for all regulatory filings
  • Support Quality audits and technical visits as needed
  • Manage timelines to meet corporate goals
  • What You Will Bring

  • MS or BS in relevant scientific field or discipline, 15+ years and strong scientific background in Quality Control and Quality Assurance for the drug development industry with strong knowledge of cGMP/ICH/FDA/EMA regulations
  • Strong leadership and people management skills and demonstrated ability to work in a productive and collaborative cross-functional manner
  • Prior experience in Quality for cell therapy products as well as oversight of Quality at contract organizations preferred
  • Highly collaborative team player who fosters open communication and transparency and ensures involvement of key stakeholders in decision-making
  • 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
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects
  • 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.



    #LI-DNI

    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

    Get Notified of Open Positions!

    Sign up to receive emails when ArsenalBio posts open positions you might be interested in:

    First Name

    Last Name

    Email

    Tel # (Optional)

    Location (Optional)

    Current Company (Optional)

    Current Job Title (Optional)

    {{alert.msg}}