Technician II-GXP - Applied Gene & Cell Therapy Center (Operations, Controls, and Support Group)

Cincinnati Children's; Cincinnati (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

An established industry player in healthcare is seeking a Technician II to join their Applied Gene & Cell Therapy Center. In this role, you will manufacture and test cell products for clinical trials while ensuring compliance with GxP standards. Your responsibilities will include maintaining detailed records, performing environmental monitoring, and supporting equipment calibration. This position offers a unique opportunity to contribute to groundbreaking therapies in a collaborative environment that values diversity and inclusion. If you're passionate about making a difference in the field of gene therapy, this role is perfect for you.

Qualifications

• 0-2 years of experience in a related job discipline.
• Experience in a regulated environment (FDA, ISO, etc.) is preferred.

Responsibilities

• Complete records and documentation for GxP compliance.
• Perform maintenance and cleaning of the cleanroom facility.
• Assist in training laboratory personnel and mentoring junior staff.

Skills

Data Analysis

Statistical Analysis

Problem Solving

Good Documentation Practices

Environmental Monitoring

Education

Bachelor's degree in a related field

Tools

Laboratory Equipment

Job description

Company: Cincinnati Children's
Location: Cincinnati, OH
Employment Type: Full Time
Date Posted: 08/15/2024
Job Categories: Healthcare, Other, Research & Development, Medical

Job Title: Technician II-GXP - Applied Gene & Cell Therapy Center (Operations, Controls, and Support Group)

Expected Starting Salary Range: 21.21 - 25.86

SUBFUNCTION DEFINITION: Manufactures and tests cell in gene therapy products for internal and external phase I/II clinical trials.

REPRESENTATIVE RESPONSIBILITIES

1. GMP Technician - Complete accurate and detailed records and all documentation as required for compliance to GxP. Complete and maintain training required to perform assigned tasks. Analyze data, perform statistical and graphical analysis of data, and interpret results. Maintain an active role in laboratory's meetings.
2. Operations - Perform maintenance and cleaning of the cleanroom manufacturing facility. Routinely perform the Environmental Monitoring sampling and/or testing of the sampled media. Support equipment calibration and validation. Complete accurate and detailed records. Promptly respond to and troubleshoot erroneous results or problems with laboratory equipment or facilities. Order supplies from vendors and storeroom and ensure proper storage requirements are met. Report facility and equipment failure and alarms to laboratory management or QA team.
3. Compliance - Perform work with a high level of integrity and honesty. Practice a high level of integrity in maintaining confidentiality. Maintain required documentation systems. Willing and able to assist in daily operations of the laboratory including answering phone, organizing and cleaning of laboratory. Provides appropriate safety monitoring checks as assigned (radiation safety, biosafety, etc.) Perform other duties as assigned.
4. Process Improvement - Follow Standard Operating Procedures (SOP) and protocols. Cooperate with performance improvement initiatives and other compliance activities. Cooperate with Quality Assurance group to ensure the quality of product, test results and compliance. Perform assigned duties strictly according to SOP. Maintain required proficiency and competency requirements.
5. Training & Development - Assist in training laboratory personnel. May act as a mentor to more junior staff. Serve as the contact for resolution of complex issues, provide education, guidance and work direction. May provide input and feedback to managers on hiring decisions, professional development and performance management.

EDUCATION/EXPERIENCE

Required: Bachelor's degree in a related field, 0 - 2 years of work experience in a related job discipline.

Preferred:

Experience in a regulated environment (i.e. FDA, ISO, CAP, CLIA, FACT)

cGMP experience in some or all of the following:

• Good Documentation Practices
• Material Receipt and Control
• Cleanroom Operations and Controls
• Laboratory Equipment Operation, Calibration, and Validation
• Environmental Monitoring (i.e. Sampling and monitoring of viable and non-viable particulates)

Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/AA/M/F/Veteran/Disability