Northwestern Medicine
Cellular Therapy Scientist - Transplant Lab, Full-Time, Days
Northwestern Medicine, Chicago, Illinois, United States, 60290
Description
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 assists 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
Qualifications 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.).
Equal Opportunity Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.
Benefits We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more.
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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 assists 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
Qualifications 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.).
Equal Opportunity Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.
Benefits We offer a wide range of benefits that provide employees with tools and resources to improve their physical, emotional, and financial well-being while providing protection for unexpected life events. Please visit our Benefits section to learn more.
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