Job Description

Scismic is supporting the growth of a biotech company that is developing a novel pipeline of TIL (tumor-infiltrating lymphocyte) therapies in oncology. We’re looking for a highly motivated scientist with a strong background in analytical development to help drive the development of multiple cell therapy products in our pipeline targeting cancer. As part of our Technical Development and Manufacturing department you will be a vital part of a highly collaborative team working to achieve our company's vision by translating innovative science into medical breakthroughs for patients, starting with our lead program engineered to make TILs more effective for more patients.

This is a unique opportunity in a well-funded pre-clinical company with blue-chip investors, field-leading advisors, and a highly experienced team. You will help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.

YOU WILL…

• Apply your expertise in developing and qualifying analytical assays to support the release and characterization of viral vector starting materials and cell therapy products for early and late phase clinical trials
• Design, plan, and execute experiments in Analytical Development, working both independently and as part of a multidisciplinary team of researchers, including partnering closely with the process development team
• Support method development and provide technical expertise for the transfer and qualification of assays to assess identity, purity, safety and potency of viral vectors (eg retroviral vectors) and engineered primary cells (eg T cells, Tumor Infiltrating Lymphocytes)
• Support introduction of new analytical technologies, implementation of common reagents and controls, trending of data, and transfer of analytical methods
• Interpret results, troubleshoot technical hurdles, and propose solutions to the team
• Maintain excellent records of experiments, including Electronic Notebook entries.
• Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods
• Collaborate effectively across our organization, present internally to project teams, management, and scientific teams.

YOU BRING…

Core Qualifications

• Ph.D. in a relevant discipline (immunology, biochemistry, cell biology, engineering, or related field) or MS and 7+ years of relevant industry experience.
• Subject matter expertise in product characterization methods relevant to an immune cell-based product and viral vector (retroviral/ lentiviral) starting materials, with a focus on molecular and immunoassay development (PCR / qPCR, ddPCR, ELISA, MSD and western blot) and cell culture skills
• Strong troubleshooting and communication skills, highly organized with strong record-keeping and an ability to multi-task
• Highly collaborative working style and ability to adapt in a fast paced, rapidly developing environment
• Ability to work with minimal direction to meet objectives and timelines, adapting to changes and priorities in order to fulfill our mission

Bonus Qualifications

• Experience with multi-parameter flow cytometry assays, cell line/ primary cell transduction/ transfection, and cell-based assay development
• Demonstrated track record with analytical development supporting early and/or late-stage development of biologics
• Demonstrated track record with analytical development and method qualification for characterization of engineered cell therapies or viral vectors
• Experience with Design of Experiment (DOE) approaches and application to analytical development
• Experience working with CDMOs/ CTLs for method transfer/ development/ qualification/ validation
• Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy analytical development and method validation