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CTMC · 2 days ago

QC Specialist IV

Houston, TX

Full-time

Onsite

Senior Level

5+ years exp

CTMC is a pioneering biotech joint venture focused on accelerating cell therapies from bench to bedside. The QC Specialist IV will lead analytical method qualification and validation activities, ensuring compliance with regulatory expectations while supporting the release and characterization of cell and gene therapy products.

BiopharmaBiotechnologyTherapeutics

H1B Sponsor Likely

Hiring Manager

Jenifer Klemme

Responsibilities

Lead and execute analytical method qualification and validation activities for QC assays supporting the release and characterization of cell and gene therapy products. Ensure study design, execution, and reporting are compliant with ICH and FDA expectations

Apply subject matter expertise across key analytical platforms, including:

Flow cytometry for phenotyping, purity, and functional marker expression

Molecular assays (qPCR/ddPCR) for vector copy number (VCN) determination

Immunoassays such as IFN-γ ELISA for functional potency assessment

Automated cell counting and viability using systems such as the Cellometer and NC-200

Design, author, and oversee analytical method qualification and validation in compliance with ICH guidelines

Partner closely with Analytical Development to ensure seamless and compliant transfer of analytical methods into QC

Author, review, and approve technical documents including SOPs, validation protocols, qualification reports, and analytical methods. Ensure scientific integrity and regulatory readiness of all deliverables

Provide SME-level guidance and training to QC analysts, fostering technical proficiency and consistency in execution

Support regulatory submissions, audits, and inspections by preparing method validation summaries, presenting data, and defending QC analytical approaches

Lead or contribute to laboratory investigations (OOS, OOT, deviations) with emphasis on method performance, data integrity, and scientifically justified root cause determination

Continuously monitor assay performance, trend analytical data, and implement improvements or requalification as needed

Ensure all QC analytical activities are conducted in full compliance with cGMP, ICH Q2(R2), and applicable global regulatory standards

Engage in external-facing technical discussions with partners, collaborators, and contract laboratories to align on analytical expectations, study designs, and data interpretations. Represent CTMC QC in cross-functional and partner project meetings with professionalism and scientific rigor

Other duties as required

Qualification

Analytical method qualificationFlow cytometryMolecular assays (qPCR/ddPCR)ELISAAutomated cell countingRegulatory guidelines knowledgeTechnical documentationLaboratory Information Management Systems (LIMS)Communication skillsOrganizational skills

Required

Bachelor's degree in a scientific discipline

5+ years of QC or analytical development experience in a GMP-regulated environment or equivalent combination of education and experience

Proven experience in analytical method qualification and validation, including protocol design, execution, and data interpretation

Hands-on expertise with flow cytometry, molecular assays (qPCR/ddPCR), ELISA, and automated cell counting and viability platforms

Demonstrated ability to function as a subject matter expert (SME) for QC analytical methods and provide technical leadership within cross-functional teams

Proficient in authoring and reviewing technical documentation, including SOPs, validation protocols, qualification reports, and investigations

Familiarity with Laboratory Information Management Systems (LIMS) and electronic data workflows to support data integrity and compliance

Strong understanding of regulatory guidelines (ICH, FDA, EMA) governing analytical method validation and QC operations

Excellent organizational skills with the ability to manage multiple priorities, projects, and timelines in a dynamic environment

Effective communication and collaboration skills, with the ability to engage confidently across diverse teams and external partners

Able to work flexible work hours to ensure continuity of manufacturing and release activities

Preferred

advanced degree preferred

Company

CTMC

CTMC is a clinical cancer center to enable innovation from academia and biotech to accelerate cell therapy’s impact on cancer patients.

Founded in 2022

Houston, Texas, USA

51-200 employees

https://ctmc.com

H1B Sponsorship

CTMC has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2025 (2)

2022 (1)