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 productsDefine and execute in-process, product, and in-use stability studiesDevelop and implement process improvements (e.g. process closure) to improve robustness, scalability and COGs of cell therapy productsCompile 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 risksSupport operational start-up and technology transfer activities, including, generation of risk assessments, manufacturing batch records, standard operating procedures (SOPs), and training materialsProvide on-the-floor manufacturing operations support and participate in RCAsSupport clinical subteam with closure of drug product-related clinical deviationsDefine, execute, and author process validation study plans and reportsEstablish process monitoring trendsCollaborate closely with other functions to enable effective and successful project executionActively engage in cross-functional collaboration with peers to overcome technical challengesOrganize, communicate, and present complex data sets to key stakeholders and senior managementAssist cross-functional activities including hand-offs to various teams, compiling data, and presenting at project meetingsAssist 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 requiredExperience with human immune cell isolation, T cell expansion, and mammalian cell culture techniques is desirableUnderstanding of and experience with cGMP environment, Design of Experiment (DOE), and Quality by Design (QBD) principles for process and assay development, qualification, and validation requiredExperience working in cGMP environment in supporting equipment set-up, commissioning, qualification is preferredExperience working in cGMP environment and within Quality management systems is requiredPrior experience in cell therapy and/or process development teams preferredExperience in multi-color flow cytometry analyses including panel design and data analysis preferredExperience in T cell functional assays including cytotoxicity, cytokine/chemokine, and proliferation a plusAbility to quickly adapt and learn new skills for changing research prioritiesFlexible mind with the ability to think outside the box, creative approach to problem-solvingDemonstrated ability to work well in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlinesWillingness 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.
