Description
The 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 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
Additional 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 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
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 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.).
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.
