Northwestern Medicine · 13 hours ago
Senior Cellular Therapy Scientist - Cell Therapy Lab, Full-Time, Days
710 N. Fairbanks, Chicago, IL
Full-time
Onsite
Mid, Senior Level
3+ years expNorthwestern Medicine is a leader in the healthcare industry, committed to providing a patient-first approach. They are seeking a Senior Cellular Therapy Scientist to oversee the manufacturing of cell and gene therapy products, ensuring compliance with regulatory standards and quality control processes.
Emergency MedicineHealth CareHospitalMedicalNutritionRehabilitation
Responsibilities
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
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
In addition to the responsibilities of a Cellular Therapy Scientist, a Senior Cellular Therapy Scientist provides technical/administrative oversight to and directs the work of personnel who may perform both routine and non-routine or specialized tests and analyses in a designated section
Assist department management to oversee the day-to-day operations
Collaborate with manager in monitoring the operations of department to ensure the service standards and financial goals are met
Coordinate the maintenance and repair activities as related to equipment and facilities
Document maintenance and repairs of equipment and facilities and file calibration, preventive maintenance, monitoring logs, and service records as required
Evaluate instruments and equipment systems and make recommendations for acquisition to facility management
Establish user requirements for purchase and qualification of equipment
Order lab equipment, parts and service requests as needed
Prepare, maintain and coordinate the environmental monitoring schedule
Participate in instrument computer software updates
Review and update laboratory Chemical Inventory and submit to NM Safety Department
Represent department at the NM Safety meetings and collaborate with the NM Safety Department on any safety issue or concern within the laboratory
Participate in preparation and monitoring of expense/revenue budgets
Participate in reconciliation of statistics and adheres to revenue management standards
Participate in coordination of HCT/P processing, manipulation, storage and transport to/from the department
Participate in Supplier and Supply Qualifications
Lead preclinical assay and process development for cell therapy product manufacturing and characterization
Lead and coordinate collection and analysis of preclinical research data and prepare internal progress reports
Lead and perform preclinical research projects utilizing a wide range of experimental cell and molecular biology techniques which include cell culture, lentivirus transduction, imaging, qPCR and flow cytometry
Develop protocols from publications and manufacturer’s recommendations
Ensure clinical trial and commercial product data management is complete and accurate
Ensure performance of proficiency testing
Qualification
Required
Bachelor's degree in Medical Technology, Medical Laboratory Science, Clinical Laboratory Science, Chemistry, Biology, immunology, Molecular Biology and other related field
Minimum of 3 ~ 5 years of relevant laboratory experience
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.)
Benefits
Tuition reimbursement
Loan forgiveness
401(k) matching
Lifecycle benefits
Company
Northwestern Medicine
Northwestern Medicine is the collaboration between Northwestern Memorial HealthCare and Northwestern University Feinberg School of Medicine around a strategic vision to transform the future of health care.
10001+ employees
H1B Sponsorship
Northwestern Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (75)
2024 (66)
2023 (70)
2022 (78)
2021 (35)
2020 (39)
Funding
Current Stage
Late StageTotal Funding
$25M2018-06-26Grant· $25M
Leadership Team
Howard Chrisman, MD
President and CEO
John A. Orsini, CPA
Senior Vice President and Chief Financial Officer
Recent News
2026-01-13
Near North Health
2025-12-01
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