The Cellular Therapy Scientist reflects the mission, vision, and values of NM, adheres to the organization’s Code of Ethics and Corporate Compliance Program, and complies with all relevant policies, procedures, guidelines and all other regulatory and accreditation standards. The incumbent will perform process development, assay development and validations under supervision of the laboratory Director as well as manufacture cellular therapy products for treatments of patients on clinical trials and standard of care plans. Responsibilities: Technical: Responsible for manufacturing of autologous and allogeneic cell and gene therapy products according to standard operating procedures, and specific guidance for clinical trials/commercial products, using aseptic technique Performs cell and gene therapy product manufacturing under GXP (GLP, GTP, GMP, GDP) guidelines and protocols to ensure the quality of cellular therapy products and regulatory compliance Performs various quality control testing of cellular therapy products and components with immunological and cell biological techniques required for the quality of cellular therapy products Performs cellular therapy product infusion preparation and product transport under established procedures Accurately document processing records, generate and review processing reports and charts Assist in inspections and audits to ensure compliance with regulations from Federal Drug Administration (FDA) and other regulatory agencies Required to wear pager to respond promptly to emergency calls and for critical equipment failure. Performs cell and gene therapy manufacturing process development, assay development, optimization, validation, and verification for cellular therapy investigational new drug applications Ability to troubleshoot issues in process and assay development, analyze results and compile reports. Performs technology transfer from lab bench to clinical manufacturing Performs preventative maintenance on facility and instruments/equipment in a timely fashion according to defined procedures and schedule Assists in equipment installation/operation/performance qualifications (IQ/OQ/PQ) Verifies reagents and supplies meet defined acceptability criteria upon receipt and prior to use; take action to ensure unacceptable items are removed from use; ensures that sufficient reagents and supplies necessary for manufacturing are available Performs and records all necessary quality control (QC) required for product manufacture, evaluate QC results and take necessary corrective actions according to established protocol Writes or assist in writing standard operating procedures Reviews results for completeness, correctness, and consistency Participate in training and competency assessment. Keep up with current knowledge of cellular therapy product manufacturing and analytical techniques and industry practices Universal responsibilities: Ensures quality of operations: Follows written standard operating procedures (SOP) Operates instruments/equipment according to protocol Uses computers according to established protocol; follows downtime procedures as required Performs required quality system responsibilities Participates in the training of new employees, fellows and students Attends at least one personal development session per year Performs other duties as assigned, or as needed, to ensure continued quality operations Ensures safety of operations: Follows all required safety procedures, uses personal protective equipment (PPE) appropriate for tasks performed, and assumes a proactive role in laboratory safety Maintains clean and organized work area Provides service excellence: Answers telephone when needed, using NM telephone etiquette Maintains patient confidentiality including protected health information (PHI) Assists patients, visitors and other contacts whenever need occurs
Required : Bachelor’s degree in Medical Technology, Medical Laboratory Science, Clinical Laboratory Science, Chemistry, Biology, immunology, Molecular Biology and other related field. Minimum of 1~2 years of relevant laboratory experience including training in a technical specialty. Preferred: Master’s degree or higher in Chemistry, Biology, immunology, Molecular Biology and other related field. Working Experience in a cellular therapy laboratory or in clinical hematology or blood bank setting preferred. Bone marrow and/or stem cell processing, blood banking, hematology, cell culture and apheresis. Experience with processing of either mammalian cells for upstream and downstream processing of viral vectors, or primary tissue and human blood for the isolation and expansion of immune cell populations (e.g. T-cells, NK cells, T-regs, monocytes, dendritic cells, etc.) and also characterization assays for cells and proteins (flow cytometry, ELISA, functional assays, etc.).
Northwestern Medicine is an equal opportunity employer (disability, VETS) and does not discriminate in hiring or employment on the basis of