Technical Operations

Senior Manager/Associate Director - Technical Operations, Analytical Development

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 Manager/Associate Director to join the ArsenalBio Technical Operations team. The individual will work closely with Process Development, Manufacturing, and Quality team members to lead the development and provide scientific and technical leadership on analytical method assessment, development, qualification, transfer, and troubleshooting. The role will also include developing methods for product characterization in support of ArsenalBio’s clinical product. This position will report into the Director of Technical Operations and will interact cross-functionally across the organization to enable the success of ArsenalBio.

What You Will Do:

  • Independently lead the design and implementation of quality-based analytic assays to support the characterization and release of cell therapy products, driving the development and implementation of overall analytical control strategy
  • Manage the Analytical Development team, overseeing analytical method development and qualification studies.
  • Provide oversight of analytical method transfer to Quality Control, qualification and validation activities. Troubleshoot method performance, as needed
  • Provide technical expertise and leadership within project teams and in a matrix environment.
  • Assist in defining and executing overall analytical development strategy enabling accelerated CMC development timelines
  • Establish process for tracking and trending analytical analyses of process development and cGMP production runs, including evaluation of critical reagents and lot to lot variability, in order to improve process standardization.
  • Good understanding of cGMP environment, and Quality by Design (QBD) principles for process and assay development, qualification and validation highly preferred.
  • Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challenges
  • Maintain proficiency in the latest analytical technologies as well as emerging analytical development strategies
  • Organize, communicate, and present complex data sets to key stakeholders and senior management
  • Author and review technical development documents and relevant sections of health authority filings
  • What You Will Bring:

  • Advanced degree in relevant scientific field. At least 6-10 years experience in biotechnology/pharmaceutical industry in an Analytical Development role
  • Expertise in development of analytical methods for cell therapy products required
  • Demonstrated track record of successfully developing, qualifying, transferring analytical methods
  • Strong background in flow cytometry, cell-based assays, and other analytical methods for cell therapy products
  • Strong grasp of statistical approaches for design of experiments (DoE) analytical method development, robustness testing, data analysis
  • Previous experience successfully managing multidisciplinary analytical teams to meet program milestones and timelines
  • In depth knowledge of US and European regulatory requirements for cGMP
  • Expertise in transfer of methods to Quality Control, management of external vendors (central testing labs, contract manufacturing organizations), partnerships, with the ability to manage multiple technical projects successfully
  • Excellent strategic thinking skills with demonstrated ability to successfully create and implement short and long range plans to support product development strategy
  • Strong leadership skills, experience managing diverse teams, mentoring junior team members
  • Proficient in analyzing technical data and preparing written technical reports
  • Excellent oral and written communication skills, detail-oriented, scientifically-driven
  • 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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