Cell/Gene Therapy Laboratory Technician

Indiana University; Indianapolis (IN); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

Medical & dental

HSA contributions

FSA

Life insurance

Retirement plan

Tuition subsidy

Holidays

Paid time off

Parental leave

EAP

Job summary

Indiana University’s Cell Immunotherapy & Transduction Facility (CIT) seeks a Laboratory Technician to manufacture and test cellular products per established SOPs. You will learn aseptic techniques, good documentation, and GMP practices while supporting early-phase clinical trials.

Ideal candidates hold a Bachelor's in science or related field and have 1+ year of lab experience, with GMP/GLP/CLIA/CAP exposure preferred. Work location is Indianapolis with weekend/evening shifts.

Qualifications

• Bachelor's degree in science or health-related field required.
• Minimum 1 year of laboratory experience required.
• 3 years of GMP/GLP/CLIA/CAP‑compliant lab experience preferred.
• GxP compliance experience preferred.

Responsibilities

• Cleans facility and equipment.
• Performs equipment verification.
• Orders and receipts approved supplies.
• Manufactures and tests cellular products per SOPs.
• Develops/manages new manufacturing or testing methods.
• Performs environmental monitoring and facility readiness.
• Supports supervisors with deviations and regulatory reporting.

Skills

Communication

Professionalism

Time management

Quality focus

Flexibility

Dependable

Education

Bachelor's degree in science or health-related field

Job description

Department CANCER CENTER (IN-CANC-IUINA) Department Information

The Indiana University (IU) Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC) is the central hub for cancer research and education across Indiana University. It is the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center and 1 of only 57 in the nation. The comprehensive designation recognizes the center's excellence in basic, clinical, and population research; outstanding educational activities; and effective community outreach across the state.

Cell Immunotherapy & Transduction Facility (CIT) is an International Organization for Standardization (ISO) Class 7 cleanroom facility and quality control testing laboratory at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center (IUSCCC) that manufactures and tests cellular products for patients on early phase clinical trials. The CIT follows Good Manufacturing Practices to make safe products for patient use according to FDA regulations.

Job Summary

The Cell/Gene Therapy Laboratory Technician will manufacture and test cellular products according to established procedures. Staff will be trained on and are expected to become competent in aseptic technique, good documentation practices, and good manufacturing practices.

Department-Specific Responsibilities

• Cleans facility and equipment.
• Performs equipment verification.
• Orders and receipts approved supplies.

General Responsibilities

• Conducts biologic manufacturing processes, biologic and molecular analysis according to defined standard operating procedures for gene therapy vector products, or cellular products, transduced cells, patient samples, and more.
• Participates in the development of new manufacturing or testing methods and protocols.
• Performs preventative maintenance and verification of facility and lab equipment and environmental monitoring equipment.
• Performs environmental monitoring and facility readiness.
• Supports supervisors in managing unexpected occurrences, deviations, and out-of-specification results so that reporting of unexpected findings are evaluated in compliance with government regulations including, but not limited to, the FDA, Federal Aviation Administration (FAA), and others.

Qualifications

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

Education

Required Bachelor's degree in science or a health-related field.

Work Experience

• Required 1 year of laboratory experience.
• Preferred 3 years of laboratory experience including GxP (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Tissue Practice (GTP), Clinical Laboratory Improvement Amendments (CLIA) or College of American Pathologists (CAP)) compliant laboratory experience.

SKILLS

• Required Proficient communication skills.
• Maintains a high degree of professionalism.
• Demonstrated time management and priority setting skills.
• Demonstrates a high commitment to quality.
• Possesses flexibility to work in a fast-paced, dynamic environment.
• Highly thorough and dependable.

Working Conditions / Demands

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.

Work Location

University Hospital Ambulatory Outpatient Center Lab (AOC) 6013 550 North University Boulevard Indianapolis, Indiana 46202

Work Hours

Work hours are defined by processes and will include periodic weekend and evening work.

Benefits Overview

For full-time staff employees, Indiana University offers a wide array of benefits including:

• Comprehensive medical and dental insurance
• Health savings account with generous IU contributions
• Healthcare and dependent care flexible spending accounts
• Basic group life insurance paid by IU
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance
• Base retirement plan with generous IU contributions, subject to vesting
• Voluntary supplemental retirement plan options
• Tuition subsidy for employees and family members taking IU courses
• 10 paid holidays plus a paid winter break each year
• Generous paid time off plans
• Paid leave for new parents and IU-sponsored volunteer events
• Employee assistance program (EAP)

Job Classification

Career Level: Intermediate FLSA: Nonexempt Job Function: Research Job Family: Cell and Gene Therapy

Equal Employment Opportunity

Equal Employment Opportunity Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.