Welcome to DiscGenics, a pioneering, late-clinical stage biopharmaceutical company dedicated to advancing regenerative cell-based therapies for patients suffering from degenerative diseases of the spine. Privately held and passionately driven, our mission is to enhance lives by alleviating pain and restoring function through innovative treatment.
At DiscGenics, we are committed to improving the quality of life for individuals debilitated by degenerative diseases of the spine. Our focus lies in developing cutting-edge therapies that offer hope and tangible results, fostering a future where patients can regain mobility and comfort.
Our team is characterized by a relentless pursuit of excellence and a nimble approach to addressing challenges. Our core values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship guide everything we do.
Join us at DiscGenics and be part of a transformative journey where your contributions have the potential to impact the lives of millions. Together we innovate with purpose and compassion, striving towards a future where pain and limitations of degenerative spine diseases are a thing of the past.
Discover more about us at discgenics.com and see how you can contribute to revolutionizing patient care through regenerative therapies.
Job 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.
This role interacts with all levels of the organization in a collaborative and positive way with colleagues to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values.
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.
Working Conditions:
Position requires qualified individuals to see, hear and speak (verbally and audibly). Required to ascend and descend stairs; sit, stand, lift, bend, stoop, crawl and kneel. The employee must also use hands to finger, handle or feel. Occasionally reaching with hands and arms, climbing or balancing are required. May be asked to drive or travel by car, air, or other transportation for business purposes.
Must be able to lift and carry up to 20 pounds.
Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.
Disclaimer:
Please note: DiscGenics reserves the right to change, modify, suspend, interpret, or cancel in whole, or in part, any of the duties outlined above, at any time, and without advance notice to the employee.
