Overview
Cellular Therapy Scientist – Transplant Lab, Full-Time, Days Jobs in Chicago, IL at Northwestern Medicine
Benefits
$10,000 Tuition Reimbursement per year ($5,700 part-time)
$10,000 Student Loan Repayment ($5,000 part-time)
$1,000 Professional Development per year ($500 part-time)
$250 Wellbeing Fund per year($125 for part-time)
Annual Employee Merit Increase and Incentive Bonus
Paid time off and Holiday pay
Pay: Based on experience, starting at: $27.83 + per hour.
Description
TheCellular Therapy Scientistreflects 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 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 estab…
Title: Cellular Therapy Scientist – Transplant Lab, Full-Time, Days
Company: Northwestern Medicine
Location: Chicago, IL
Category:
