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 Senior Director of Quality functions as the Management Representative and Head of Quality functions at DiscGenics (that includes Quality Assurance, Quality Control, and Microbiology) reporting directly to the CEO. Responsible for facilitating Management Review and the implementation of and maintaining a compliant Quality Management System (QMS) to support DiscGenics clinical trial initiatives, cGMP commercial manufacturing operations, and preparations for regulatory filings in advance of commercial approval in defined markets.
The Senior Director, Quality documents, monitors, and assures compliance to the Quality Management System with applicable government jurisdiction regulations. Responsible for building, managing, and mentoring a team of quality professionals that will train the organization on applicable regulatory requirements and ensure that the organization maintains compliance with applicable regulations.
This individual fulfills the Quality Policy by implementing Quality Objectives that are aimed at improving the Quality Management System. Delivers collaborative and positive leadership to facilitate department and organizational initiatives for cultural cohesion aligned to the DiscGenics Values.
Essential Duties and Responsibilities:
Serve as Management Representative for DiscGenics, including facilitation of Management Review. Identify trends in quality metrics to assess the effectiveness of the QMS and devise plans to improve quality systems. Develop and fully implement a Quality Management System that is compliant with FDA and applicable global market regulations. Navigate multiple regulatory requirements including FDA 21 CFR Parts 210/211, 600-680, 820, and 1271, Japan PMDA regulations, and ICH guidelines. Fully implement an electronic quality management system (eQMS) and/or other Quality information system to support compliance of quality systems. Establish and maintain design control, quality by design (QBD), and risk management programs. Qualify raw materials and components and their suppliers, and ensure quality agreements are in place. Oversee adherence to quality system, manufacturing batch records/SOP’s, and applicable in-process and final safety and release testing for IDCT cGMP dose manufacturing.Responsible for ensuring that documented evidence exists that demonstrates the conformance of products to pre-defined specification criteria and for release of such products. Execute external quality audits of suppliers as required per internal procedures. Supports clinical trial execution compliance to the appropriate SOP’s for both DGx and CRO vendors.Responsible for document control, internal quality audits, complaint and corrective action systems, supplier quality, and training. This individual is responsible for control of nonconforming products including their segregation, quarantine, disposition, and disposal, and is the Chairperson of and the Material Review Board. Build Quality (QA, QE, QC) staffing (inclusive of contractors) to support commercial facility and full cGMP readiness (inclusive of regulator audit readiness).Maintains and evolves the Quality Control Analytical and Microbiology labs and the plant environmental monitoring program. Complete QA/QC and other applicable sections of US FDA, and Japanese PMDA and other regulatory submissions. Other duties as assigned.Job Requirements:
Experience with 21 CFR 211 and/or 21 CFR 820 and/or 21 CFR 1271 Familiarity and experience with International Conference of Harmonization (ICH) guidelines Experience performing internal and/or external audits Able to proactively identify quality gaps, and implement appropriate solutions that consider the needs of all company departments Strong communication and technical writing skills Impeccable attention to detail Team leadership skills and team player Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship.Regular and predictable attendance. Ability to report to work unimpairedEducation and Experience:
Minimum 8-10 years’ experience in Quality Management in life sciences (directly in cell therapy, biologics, or other related biopharma sectors), with specific successful management experience in building and successfully implementing a QMS. Minimum bachelor's degree in relevant field, advanced degree preferred. Considerable experience with successful eQMS and/or other Quality information system RFP process, contract negotiations, implementation, and roll out. Considerable experience with cell therapy comparability research and other forms of testing/analysis inclusive of release testing (including potency assay development) and stability testing preferred. Considerable experience in cell therapy cGMP manufacturing for both late-stage and clinical and commercial launch preferred (inclusive of BLA submission and approval).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.
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.
We are looking for a talented and dedicated Analytical Scientist to join our team! The Scientist/Senior Scientist, Analytical Sciences is responsible for the development, optimization, qualification, validation, and execution of analytical methods supporting raw materials, in-process, intermediate, and finished product testing for cell therapy products. This role plays a key part in advancing analytical strategies from early development through commercialization, ensuring compliance with FDA and ICH guidelines.
The position includes leading and supporting cell-based development (e.g., ELISA, flow cytometry, potency assays), evaluating new analytical technologies, and enabling method transfer to Quality Control and external partners. The role also contributes to regulatory filings through authoring and reviewing technical reports and CMC sections.
This role collaborates cross-functionally with Process Development, Manufacturing, and Quality teams, while supporting a culture aligned with company values.
Essential Duties and Responsibilities
Analytical Development & Execution
Design, develop, optimize, qualify, validate, and execute analytical methods for product characterization and release.Lead and/or support development of cell-based bioassays, potency assays, immunophenotyping, and multiplexed protein assays.Perform routine testing to support development studies and clinical batch release.Track, trend, and statistically analyze data to evaluate method performance and support specification setting.Method Lifecycle & Technology Transfer
Advance analytical methods from concept through qualification and transfer to Quality Control and external partners.Apply Quality by Design (QbD) and Design of Experiments (DOE) principles to method development. Support scale-up and commercialization of analytical methods.Manage outsourced testing activities when needed.Collaboration & Leadership
Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams.Present scientific data and serve as subject matter expert (SME) for analytical methods.Lead or mentor junior scientists and assist in training on analytical methods.Support and contribute to departmental and organizational initiatives.Laboratory Operations
Maintain, calibrate, and operate laboratory equipment and instrumentation.Ensure proper documentation and organization or experimental data.Participate in equipment qualification and upkeep.Additional Responsibilities
Contribute to risk assessments, comparability studies, and specification justifications.Perform other duties as required.Education & Experience
Bachelor’s degree in biological sciences, biochemistry, chemistry, cell biology, or a related field with 7-10+ years of relevant industry experience, OR Master’s degree in a related field with 5-8+ years of experience, OR PhD in a related field with 2-5+ years of experience.10+ years of experience preferred, particularly within GMP/CMC or other regulated environments and spanning development through commercialization.Experience supporting clinical and commercial development of pharmaceutical, biological, or cell therapy products, including scale-up to commercialization.Hands-on experience with analytical method development (e.g., immunoassays, multi-parameter flow cytometry, cell-based potency assays) in a QC or regulated setting preferred.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.
Read LessWelcome 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.
Summary:
As DiscGenics prepares to commercialize IDCT, the Senior Manufacturing Associate will be a critical role in executing the daily functions of making IDCT from engineering through commercial production.
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.
Essential Duties and Responsibilities:
Execute cell culture manufacturing processes, within a cleanroom environment, with minimal supervision.Execute aseptic manufacturing processes within a biological safety cabinet.Train junior employees in all aspects of cGMP manufacturing.Ability to step in and lead a team when supervisor is not present.Ability to troubleshoot mechanical and process issues.Maintain production records to comply with cGMP and regulatory requirements.Participate in the development and execution of validation protocols, equipment IOQ/PQ, and SOP creation.Other duties as assignedJob Requirements:
Bachelor’s degree in related field with 6 years relevant experience or high school diploma with 9 years of relevant experience.Proficient with computers and administrative software.Flexible team player, able to adapt to fast pace, changing environmentExceptional time management and multi-tasking skills.Team leadership skills and team player. Adheres to and leads with the 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.Working Conditions:
Position requires weekend availability.
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 50 pounds. This position is in the production plant, employees must be able to stand on their feet between 7-9 hours daily, while wearing cleaning room attire which includes mask and gloves.
Must be able to function effectively with noise in a lab environment. Natural and regular stressors occur on the job.
Must be able to work unimpaired.
Weekend and shift work may be required in the future.
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.
