Technical Operations

Associate Director, Process Engineering

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.

ArsenalBio is seeking a driven and experienced Associate Director to lead process engineering, characterization and late-stage validation efforts in support of clinical scale manufacturing. The ideal candidate will focus on 1) harvest/fill/finish and cryopreservation parameters; 2) process parameter optimization; 3) assessment of equipment and processes to streamline and close manufacturing of cell product; 4) integration of assays for in-process controls to monitor success of manufacturing runs; and 5) writing detailed procedures, test protocols, technology transfer documentation, and regulatory documents.

What You Will Do:

  • Lead the characterization and validation of the clinical scale manufacturing process
  • Establish process closure, harvest/fill/finish, and cryopreservation workflows forclinical scale manufacturing process
  • Develop and implement process improvements to improve robustness, scalability and COGs of cell therapy products
  • Act as equipment Subject Matter Expert - supporting equipment set-up, commissioning and qualification (IQ, OQ, PQ), training, and troubleshooting technical issues.
  • Provide strategy and execution of process validation plans
  • Establish process monitoring and trending
  • Analyze data to provide support for process improvement and investigations.
  • Support process FMEAs to understand process and product risks.
  • Participate in continuous improvement projects supporting clinical manufacturing
  • Support operational start-up and technology transfer activities, including, generation of risk assessments, manufacturing batch records, standard operating procedures (SOPs), and training materials.
  • Develop and implement phase appropriate strategies for efficient transfers and verification/validation/comparability execution
  • Support regulatory filings, site readiness, and facility startup as needed.
  • Identify root cause and provide impact assessments to maintain routine manufacturing operations and determine process improvements.
  • Perform troubleshooting and testing of experimental workflows
  • Keep detailed logs of studies to contribute to the dissemination of results
  • Author and review technical reports and source documentation supporting regulatory submissions
  • Support and maintain reagent inventory, instrument maintenance, SOP writing, and related administrative tasks
  • What You Will Bring:

  • BS degree in Life Sciences, Engineering, or a related field with 7+ years of biotechnology/pharmaceutical manufacturing related experience, including Cell Therapy.
  • 2+ years of research experience involving primary cell isolation/culture and multi-dimensional flow cytometry required
  • Practical knowledge of cGMP application and aseptic/sterile technique in ISO 7/Grade B and ISO 5/Grade A environments in the cell therapy space
  • Strong desire for experience in startup/qualification of facility and process, adapting and thriving in a rapidly changing and fast-moving environment.
  • Ability to understand manufacturing process and equipment, review/approve/implement Installation/Operation/Performance Qualification (IQ/OQ/PQ), process flow diagrams, engineering drawings/manuals, technical specifications, etc.
  • Experience in clinical scale cell processing, process closure, harvest/fill/finish, cryopreservation desired
  • Experience with gene editing workflows, automation workflows, and databasingdesired
  • Excellent written and verbal communication skills
  • Ability to quickly learn new skills and knowledge on the job, demonstrate productivity, and deliver high-quality results
  • Technically minded with an aptitude for process optimization and characterization
  • Excellent teamwork and collaboration skills
  • Ability to multitask as needed in a start-up environment
  • 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

    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}}