The Senior Cellular Therapy Scientist is responsible for the manufacturing of cell and gene therapy products, ensuring compliance with regulatory standards. They also provide technical oversight and assist in the day-to-day operations of the laboratory.
Requirements summary
A bachelor's degree in a relevant field and 3-5 years of laboratory experience are required, with a preference for a master's degree and experience in cellular therapy. Skills in cell culture, quality control, and regulatory compliance are essential.
Company DescriptionAt Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace.
This patient-first approach is what sets us apart as a leader in the healthcare industry.
As an integral part of our team, you'll have the opportunity to join our quest for better health care, no matter where you work within the Northwestern Medicine system.
We pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, our goal is to take care of our employees.
Ready to join our quest for better?Job DescriptionThe Senior 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.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.
Benefits
Tuition Reimbursement
401k Matching
Loan Forgiveness
Lifecycle Benefits
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 occursAdditional responsibilities: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 operationsCollaborate with manager in monitoring the operations of department to ensure the service standards and financial goals are metCoordinate the maintenance and repair activities as related to equipment and facilitiesDocument maintenance and repairs of equipment and facilities and file calibration, preventive maintenance, monitoring logs, and service records as requiredEvaluate instruments and equipment systems and make recommendations for acquisition to facility managementEstablish user requirements for purchase and qualification of equipmentOrder lab equipment, parts and service requests as neededPrepare, maintain and coordinate the environmental monitoring scheduleParticipate in instrument computer software updatesReview and update laboratory Chemical Inventory and submit to NM Safety DepartmentRepresent department at the NM Safety meetings and collaborate with the NM Safety Department on any safety issue or concern within the laboratoryParticipate in preparation and monitoring of expense/revenue budgetsParticipate in reconciliation of statistics and adheres to revenue management standardsParticipate in coordination of HCT/P processing, manipulation, storage and transport to/from the departmentParticipate in Supplier and Supply QualificationsLead preclinical assay and process development for cell therapy product manufacturing and characterizationLead and coordinate collection and analysis of preclinical research data and prepare internal progress reportsLead 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 cytometryDevelop protocols from publications and manufacturer’s recommendationsEnsure clinical trial and commercial product data management is complete and accurateEnsure performance of proficiency testingQualificationsRequired: 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.).Additional InformationNorthwestern Medicine is an equal opportunity employer (disability, VETS) 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.Background CheckNorthwestern Medicine conducts a background check that includes criminal history on newly hired team members and, at times, internal transfers.
If you are offered a position with us, you will be required to complete an authorization and disclosure form that gives Northwestern Medicine permission to run the background check.
Results are evaluated on a case-by-case basis, and we follow all local, state, and federal laws, including the Illinois Health Care Worker Background Check Act.Artificial Intelligence Disclosure Artificial Intelligence (AI) tools may be used in some portions of the candidate review process for this position, however, all employment decisions will be made by a person.
BenefitsWe 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.Sign-on Bonus Eligibility (if sign-on bonus offered for position): Internal employees and rehires who left Northwestern Medicine within 1 year are not eligible for the sign on bonus.
Exception
New graduate internal employees seeking their first licensed clinical position at NM may be eligible depending upon the job family.
