QC Specialist IV

3 weeks ago

Houston, United States CTMC Full time
Job DescriptionJob Description

About CTMC

CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, and located in the renowned Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, ETC, and TCR-T. Our expert team collaborates closely with MD Anderson’s research and clinical faculty, bringing impactful cell therapies to cancer patients.

In our first year alone, we have filed four INDs, each ahead of schedule, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience, an ambitious biomanufacturing organization that has raised $2 billion in two years, enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results.

Our state-of-the-art, 60,000 sq. ft. facility in the Texas Medical Center is staffed by an integrated team of 75 industry veterans and scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our mission.

At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission.


Responsibilities

  • Perform analytical testing on cell and viral therapy products, to verify product quality, purity, and safety.
  • Accurately perform, analyze, and demonstrate proficiency on the following tests:
  • Automated and manual cell counts and viability
  • Flow cytometry analysis
  • ELISA
  • Molecular assays (PCR, ddPCR)
  • Participate as an analyst in MQ activities including authoring SOPs and FRMs.
  • Demonstrate aseptic processing of samples for relevant tests.
  • Follow laboratory’s quality control policies and procedures.
  • Document all quality control activities according to SOPs.
  • Perform and documents equipment maintenance and calibration activities according to SOPs.
  • Assist in writing new SOPs, and revising SOPs for test methods, equipment maintenance, and general laboratory practices.
  • Execute daily lab responsibilities and tasks to meet assigned schedule and deadlines.
  • Perform stability testing as scheduled and specified in the stability studies or protocol for cell therapy and viral supernatant products.
  • Assist in performing laboratory investigations related to OOS/ OOT/Abnormal analysis.
  • Assist in the execution of validation/qualification programs per ICH guidelines, cGMP and cGTP and other applicable standards.
  • Assist with equipment qualification, validation programs and/or performance qualification programs.
  • Reference material/standards characterization and trending.
  • Assist with technology transfer activities.
  • Assist area management to ensure that the lab is always in a state of readiness for a given area of relevant standards and regulations.
  • Ship and receive materials and samples to support QC testing and release.
  • Support inventory management for all QC lab activities.
  • Review and release raw materials to be used in GMP manufacturing.
  • Maintain laboratory upkeep and organization.
  • Train junior members of the team on medium-high complexity assays.
  • Other duties as required.

Qualifications/Skills

  • Bachelor’s degree in science field required or equivalent combination of education and experience.
  • 5 yr.’s analytical testing in a quality control laboratory including, automated and manual cell counts and viability, flow cytometry analysis, ELISA and molecular assays.
  • Serve as an SME one or more assay categories.
  • Experience with accurate laboratory calculations and conversions.
  • Demonstrated aptitude for managing reports.
  • Previous experience with writing SOPs preferred.
  • Demonstrated ability to collaborate effectively in a multi-disciplinary team.
  • Able to carry out planned laboratory activities with minimal supervision.
  • Shows initiative to take on additional responsibility.
  • Proficient with Microsoft Office (Excel, Outlook, etc.).
  • Able to work flexible work hours to maintain critical testing during manufacturing runs.
  • Capable of working in a fast-paced environment and communicating effectively with a diverse work group.

Working Conditions, Equipment, Physical Demands

The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands:

Equipment- Computer, printer, fax, and telephone.

Physical Demands-

  • Frequent sitting, standing, walking
  • Carrying packages and moving bins and boxes, lifting up to 10 lbs.

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.

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