Process & Analytical Development

Process Engineer (2278-R-680-PDAD)

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 Process Engineer to join the ArsenalBio Process Engineering team. The individual will work closely with cross-functional team members to develop, optimize, transfer, and troubleshoot phase-appropriate, GMP-compatible drug product (e.g. harvest, filling, freezing) manufacturing processes and procedures for our cell therapy products. After the initial transfer and implementation of the GMP process, this individual will be expected to work closely with Manufacturing Operations, MSAT, and Quality groups to provide on-the-floor manufacturing troubleshooting support, to participate in root cause analyses, to perform and document risk/impact assessments, and to author change control documents as needed. Additionally, this individual will be responsible for identifying, evaluating, and transferring improvements for drug substance (DS) and drug product (DP) manufacturing processes; and the execution and documentation of DS and DP process characterization and validation studies for later-stage projects and regulatory filings. This position will report into the Process Engineering team lead, and will also interact cross-functionally within Process Sciences (e.g. Analytical Development), Tech Ops (e.g. Manufacturing, Supply Chain, Quality), and across the organization (e.g. Clinical Subteam) to enable the success of ArsenalBio.

What You Will Do:

  • Plan, execute, analyze, and report on experiments and analytic assays to support the development, process characterization, and process validation of drug product GMP process to manufacture, characterize, and release T cell therapy products
  • Define and execute in-process, product, and in-use stability studies
  • Develop and implement process improvements (e.g. process closure) to improve robustness, scalability and COGs of cell therapy products
  • Compile documentation (protocols, batch records, and study reports) to facilitate transfer of ArsenalBio’s process to manufacturing sites (e.g. CDMO(s), internal manufacturing site(s))
  • Support process FMEAs to understand process and product risks
  • Support operational start-up and technology transfer activities, including, generation of risk assessments, manufacturing batch records, standard operating procedures (SOPs), and training materials
  • Provide on-the-floor manufacturing operations support and participate in RCAs
  • Support clinical subteam with closure of drug product-related clinical deviations
  • Define, execute, and author process validation study plans and reports
  • Establish process monitoring trends
  • Collaborate closely with other functions to enable effective and successful project execution
  • Actively engage in cross-functional collaboration with peers to overcome technical challenges
  • Organize, communicate, and present complex data sets to key stakeholders and senior management
  • Assist cross-functional activities including hand-offs to various teams, compiling data, and presenting at project meetings
  • Assist in regulatory documentation authoring and/or review

  • What Will You Bring:

  • PhD, Masters, or Bachelors in a relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, or Biochemistry)
  • 0-2 years experience with PhD or 3+ years with Masters or 5+ years with Bachelors of relevant research experience (cGMP manufacturing, T cell biology and/or immunotherapy preferred)
  • Expertise in clinical-scale cell therapy harvest, filling, and freezing techniques is required
  • Experience with human immune cell isolation, T cell expansion, and mammalian cell culture techniques is desirable
  • Understanding of and experience with cGMP environment, Design of Experiment (DOE), and Quality by Design (QBD) principles for process and assay development, qualification, and validation required
  • Experience working in cGMP environment in supporting equipment set-up, commissioning, qualification is preferred
  • Experience working in cGMP environment and within Quality management systems is required
  • Prior experience in cell therapy and/or process development teams preferred
  • Experience in multi-color flow cytometry analyses including panel design and data analysis preferred
  • Experience in T cell functional assays including cytotoxicity, cytokine/chemokine, and proliferation a plus
  • Ability to quickly adapt and learn new skills for changing research priorities
  • Flexible mind with the ability to think outside the box, creative approach to problem-solving
  • Demonstrated ability to work well in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines
  • Willingness to accept other responsibilities outside of initial job description

  • ArsenalBio prioritizes the providing of a safe and healthy workplace that is consistent with COVID-19 public health guidance and legal requirements.  In order to protect our employees and visitors, we require all visitors (including candidates) and employees to present proof of being fully vaccinated against COVID-19 when coming onsite.

    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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