Supervisor, Quality Control
DISCGENICS INC
Summary
The Supervisor, Quality Control (Bioassay) leads the day-to-day operation of DiscGenics established laboratory, overseeing a team of 1-5 QC analysts responsible for cell-based potency, identity, and functional assays supporting product release and stability testing. This role is responsible for laboratory equipment management, test method validations, sample and data integrity, investigations, and staff training development ensuring the lab operates in compliance with GMP standards.
Job description
Quality Control Duties and Responsibilities
- Demonstrate proficiency with cell-based potency assays, cell culture technique, and related bioassay instrumentation (e.g., cell culture ELISA, flow cytometry, plate-based imaging), including the ability to troubleshoot assay and instrument performance issues.
- Perform qualifications and requalification of laboratory equipment (i.e. plate readers, incubators, flow cytometer, UPLC, etc.)
- Validates and transfers cell-based and chemistry-based test methods to be performed by the QC laboratory.
- Maintain routine performance and lifecycle management of qualified equipment.
- Assist in maintenance of the product stability program.
- Receive and maintain traceability of test samples, reagents, and materials per approved procedures.
- Provide oversight of contract lab facilities supporting testing.
- Writes or revises SOPs and work instructions for current and future laboratory operations including use, maintenance and qualification of equipment, laboratory investigations, sampling procedures and test methods.
- Author and approve Out of Specification (OOS) records and Laboratory Investigation Records (LIR) by facilitating implementation of meaningful corrective and preventive actions for laboratory-related issues.
- Provide technical support for LIMS functionality related to QC assays.
- Prepares and analyzes periodic summary reports of quality control test results using Statistical Process Control (SPC) methods.
- Tracks and trends OOS results and assay performance metrics (i.e. system suitability and control trending); identify and elevate adverse trends to CAPA process and management review.
- Prepares QC data trending materials for quality management review meetings.
- Directly supervise a team of 1-5 QC analysts, including day to day workload management, performance feedback, and development.
- Serve as a qualified trainer for bioassay test methods.
- Manage bioassay/QC on-the-job training and track training metrics for direct reports.
- Other duties as assigned
Job Requirements
- Minimum 6 years of experience in a laboratory setting, with hands-on experience in cell-based/bioassay testing.
- Minimum 6 years of experience in a GMP environment.
- Experience in pharmaceutical, biologics, or cell/gene therapy industry.
- Prior experience directly supervising or leading a laboratory team, with strong team leadership skills and collaborative mindset.
- Independence and creative problem-solving abilities.
- Ability to handle highly confidential business information.
- Exceptional time management and multi-tasking skills.
- Adheres to company values of Integrity, Innovation, Accuracy, Teamwork and Stewardship.
- Regular and predictable attendance.
- Ability to report to work responsive, free from sedatives, and in a non-sedative state.
- Proficient with Microsoft Office, including Word, Excel, and PowerPoint.
Education and Experience
- B.S./B.A. in Cell Biology, Bioengineering, Biochemistry, Chemistry, or related field with 6 years of experience OR master’s degree with 4 years of experience, or PhD with 2 years of experience.
- Minimum 6 years of experience in a GMP (Good Manufacturing Practices) type environment.
Requirements
- Minimum 6 years of experience in a laboratory setting, with hands-on experience in cell-based/bioassay testing.
- Minimum 6 years of experience in a GMP environment.
- Experience in pharmaceutical, biologics, or cell/gene therapy industry.
- Prior experience directly supervising or leading a laboratory team, with strong team leadership skills and collaborative mindset.
- Independence and creative problem-solving abilities.
- Ability to handle highly confidential business information.
- Exceptional time management and multi-tasking skills.
- Adheres to company values of Integrity, Innovation, Accuracy, Teamwork and Stewardship.
- Regular and predictable attendance.
- Ability to report to work responsive, free from sedatives, and in a non-sedative state.
- Proficient with Microsoft Office, including Word, Excel, and PowerPoint.
- B.S./B.A. in Cell Biology, Bioengineering, Biochemistry, Chemistry, or related field with 6 years of experience OR master’s degree with 4 years of experience, or PhD with 2 years of experience.
Company overview
DiscGenics Inc. is a privately held, clinical-stage biotechnology company headquartered in Salt Lake City, Utah, focused on developing innovative regenerative cell-based therapies for degenerative diseases of the spine. Founded in 2007, the company specializes in creating allogeneic cell therapies derived from intervertebral disc cells to address chronic back pain, a condition affecting millions worldwide. DiscGenics' lead product candidate, IDCT (rebonuputemcel), is an injectable disc cell therapy that utilizes proprietary Discogenic Cells to treat mild to moderate degenerative disc disease. The company has raised over $71 million in funding, including a $50 million Series C round in 2020, and is conducting concurrent clinical trials in both the United States and Japan. With a team of 11-50 employees, DiscGenics operates a state-of-the-art manufacturing facility in Utah and has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for IDCT, positioning it as a pioneer in non-surgical, potentially regenerative solutions for spinal disorders.