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 techniquePerforms 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 compliancePerforms various quality control testing of cellular therapy products and components with immunological and cell biological techniques required for the quality of cellular therapy productsPerforms cellular therapy product infusion preparation and product transport under established proceduresAccurately document processing records, generate and review processing reports and chartsAssist in inspections and audits to ensure compliance with regulations from Federal Drug Administration (FDA) and other regulatory agenciesRequired 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 applicationsAbility to troubleshoot issues in process and assay development, analyze results and compile reports.Performs technology transfer from lab bench to clinical manufacturingPerforms preventative maintenance on facility and instruments/equipment in a timely fashion according to defined procedures and scheduleAssists 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 availablePerforms and records all necessary quality control (QC) required for product manufacture, evaluate QC results and take necessary corrective actions according to established protocolWrites or assist in writing standard operating proceduresReviews results for completeness, correctness, and consistencyParticipate in training and competency assessment. Keep up with current knowledge of cellular therapy product manufacturing and analytical techniques and industry practicesUniversal responsibilities:Ensures quality of operations:Follows written standard operating procedures (SOP)Operates instruments/equipment according to protocolUses computers according to established protocol; follows downtime procedures as requiredPerforms required quality system responsibilitiesParticipates in the training of new employees, fellows and studentsAttends at least one personal development session per yearPerforms other duties as assigned, or as needed, to ensure continued quality operationsEnsures safety of operations:Follows all required safety procedures, uses personal protective equipment (PPE) appropriate for tasks performed, and assumes a proactive role in laboratory safetyMaintains clean and organized work areaProvides service excellence:Answers telephone when needed, using NM telephone etiquetteMaintains patient confidentiality including protected health information (PHI)Assists patients, visitors and other contacts whenever need occurs
