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 highly motivated Scientist to lead the development of analytic assays for the characterization and release of ArsenalBio’s cell therapy products. The individual will have direct technical experience in a biopharmaceutical setting in the development of analytical characterization and release methods of cell therapy products. This position will report into the EVP and Head of R&D, who oversees Product Development or their designee. The Scientist will work closely with the Process and Technical Development team to design, evaluate, integrate and implement analytical assays to support the manufacture, characterization, and release of ArsenalBio’s chimeric antigen receptor T cell (CART) programs. The Scientist will interact cross-functionally across the organization to enable the success of upstream teams in Discovery and Technology whose activities feed Process and Technology Development, as well as the downstream manufacturing teams.
What You Will Do:Design, test, and implement quality-based analytic assays to support the characterization and release of cell therapy products.Independently plan, execute, analyze, and report assay development and qualification studies.Apply analytic assays to analyze development and manufacturing data for the development of a cGMP cell process.Provide technical expertise and leadership within project teams and in a matrix environment.Establish tracking and trending analyses of process development and cGMP production runs.Establish and draft documentation (protocols, batch records, reports) to enable transfer of ArsenalBio’s analytical methods to external CDMOGood understanding of cGMP environment, and Quality by Design (QBD) principles for process and assay development, qualification and validation.Collaborate closely with other functions to enable effective and successful project development; actively engage in cross-functional collaboration with peers to overcome challengesOrganize, communicate, and present complex data sets to key stakeholders and senior management
What You Will BringPhD (preferred), MS or BS in a relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, Biochemistry)Minimum of 3 years of relevant experience in biopharmaceutical setting, and successful performance track record in establishing and applying Analytical assays for cell therapy products Experience in technical development of analytic assays to support cell and gene therapy biologics and other advanced modalities in an early development setting Strong leadership skills and strategic problem-solving ability; ability to predict issues and identify solutionsAbility to lead successfully within extended project teams and handle multiple challenges under pressureExcellent communications and presentation skills, written and verbalExcellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
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.