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 Quality Control Analyst will have the unique experience of assisting the Quality Control laboratory move from concept to realization as part of a new company build-out.
The QC Analyst performs quality control analysis of raw material, and finished product using USP compendial tests or in-house developed analytical test methods and will play a role in transitioning analytical methods from development/qualification into QC-ready validated methods. This role will function as a hybrid QC/Analytical Sciences resource, focusing on method optimization, robustness, and lifecycle management to ensure methods are fit for purpose for routine QC use. The position will work cross-functionally to perform equipment qualifications and test method optimization, bridging, and validation activities that are reliable, repeatable, and adhere to quality procedures. This candidate will also help manage compliance programs for QC.
This role interacts with all levels of the organization. Delivers collaborative and positive leadership to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values.
Duties and Responsibilities
- Demonstrates high-level of proficiency with, and ability to troubleshoot, multiple raw material and cell culture test assays and instrumentation including cell-based potency assays, cell culture, ELISA, etc.
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Perform qualification/re-qualification requirements for laboratory equipment.
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Lead and execute method validation, transfer, and lifecycle management activities in alignment with ICH guidelines (e.g., ICH Q2) and regulatory expectations.
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Optimize and refine existing analytical methods to improve robustness, reproducibility, and suitability for routine QC release and stability testing.
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Design and execute method bridging/comparability studies when method changes are required, ensuring appropriate statistical evaluation and documentation.
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Writes SOPs and work instructions for current and future laboratory operations, including use, maintenance, and qualification of equipment, laboratory investigations, sampling procedures, and test methods.
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Receives and maintains traceability of test samples, reagents, and materials per Approved procedures.
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Author and approve Out of Specification (OOS) records and Laboratory Investigation Records (LIR) by facilitating implementation of meaningful corrective and preventative actions for laboratory-related issues.
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Prepares and analyzes periodic summary reports of quality control test results using Statistical Process Controls. Tracks and trends OOSs. Identifies and elevates adverse trends to CAPA process and management review.
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Prepares QC data trending for quality management review meetings.
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Provides oversight of contract lab facilities.
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Assist in development and maintenance of the product stability program. Qualifies, maintains, and monitors stability chambers.
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Qualified trainer for test methods
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Manages QC on the job training. Tracks training metrics.
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Provides technical support for LIMS function for QC assays.
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Collaborate closely with Analytical Development, Process Development, and Manufacturing to support PPQ readiness and regulatory submissions.
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Support PPQ activities by ensuring validated methods are in place and performing as expected during commercial release.
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Other duties as assigned
Job Requirements:
- 3-10 or more years of experience in a laboratory setting.
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3-10 or more years of experience in a GMP (Good Manufacturing Practices) type environment.
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Experience with analytical/cell-based QC instruments.
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Strong understanding of analytical method validation, transfer, and comparability principles
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Experience with statistical analysis applied to method performance (precision, accuracy, linearity, and robustness)
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Independence and creative problem-solving abilities.
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Ability to handle highly confidential business information.
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Exceptional time management and multi-tasking skills.
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Team leadership skills and team player.
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Adheres to company values of Integrity, Innovation, Accuracy, Teamwork and Stewardship.
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Regular and predictable attendance.
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Ability to report to work responsive, free from sedatives, and in a non-sedative state.
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Proficient with Microsoft Office, including Word, Excel, and PowerPoint.
Education and Experience:
- B.S./B.A. in Engineering, Biology, Chemistry, Industrial Sciences, or related field.
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3-10 years of experience in a GMP (Good Manufacturing Practices) related field.
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Experience in Pharmaceutical, Biologics, Medical Device or Cell/Gene Therapy industry.
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Preferred: Experience supporting late-stage development and PPQ/Validation readiness
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Preferred: Experience in method development or analytical sciences in addition to QC
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.
May be required to lift and carry 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.
