Quality Control Coordinator

ABOUT GALLANT

Gallant is the leader in veterinary regenerative medicine on a mission to bring transformational "ready-to-use" stem cell therapies to pets everywhere that treat the root cause of disease. With five high value clinical stage programs in development and a platform that is generating additional therapies, the company is positioned for their first FDA conditional approval in 2026, bringing a new class of therapies to animal health. Gallant is a privately-held company and backed by top venture capital firms BOLD Capital, Digitalis Ventures, Hill Creek Partners and NovaQuest, and recently completed our Series B financing. We have onsite GMP manufacturing, R&D and offices headquartered in La Jolla, CA. We offer a competitive base salary, generous health benefits, stock compensation, PTO, pet-friendly offices, and a virtual work environment as needed. We are a tight, incredibly smart and passionate team, deeply committed to our vision to bring "ready-to-use" stem cell therapies to pets worldwide. Position Summary The QC Coordinator will manage the receipt, logging, tracking, storage, distribution, and shipment of samples and clinical materials supporting Quality Control testing and stability programs for our pet-specific cell and gene therapy programs. Reporting to the Lead, Quality Control, this hands-on support role will ensure sample integrity, proper chain of custody, accurate documentation, and full compliance with current Good Manufacturing Practices (cGMP) and applicable veterinary regulatory requirements. The ideal candidate will bring strong organizational skills, meticulous attention to detail, and experience in GMP sample management and clinical material shipment within a biopharmaceutical or cell therapy environment, combined with a pragmatic, compliant approach suitable for both early clinical and late-stage commercial readiness. This is a key role that will support the QC team and enable rapid, compliant advancement of our novel therapies for pets. Key Responsibilities Receive, inspect, log, label, and track all incoming QC samples (in-process, release, stability, and retention samples) from Manufacturing and Process Development in accordance with cGMP SOPs. Manage sample chain of custody, storage conditions (refrigerated, frozen, cryogenic), inventory, and retrieval activities to maintain sample integrity. Coordinate timely distribution of samples to internal QC testing laboratories or external contract testing organizations, including preparation of shipping documentation. Prepare, package, label, and coordinate the shipment of clinical trial materials and QC samples to clinical trial sites, external testing laboratories, contract organizations, or regulatory authorities, ensuring compliance with temperature-controlled shipping requirements, chain-of-custody documentation, and applicable transport regulations (IATA, DOT) for veterinary biological materials. Monitor and document temperature-controlled shipments of clinical materials, investigate any temperature excursions or deviations during transit, and support timely resolution and reporting per cGMP and FDA CVM guidance. Support the stability program by executing scheduled sample pulls, labeling, tracking, and storage for long-term and accelerated studies. Accurately enter and maintain sample information, testing requests, shipping records, and status updates in Laboratory Information Management Systems (LIMS) or electronic documentation systems. Assist in the investigation of sample-related deviations, temperature excursions, or laboratory events and support implementation of corrective and preventive actions (CAPA). Perform routine QC laboratory support tasks including reagent preparation, equipment calibration assistance, and general housekeeping. Conduct regular sample inventory audits and maintain retention sample programs in compliance with regulatory requirements. Collaborate cross-functionally with Manufacturing, Process Development, Quality Assurance, and Regulatory Affairs teams to ensure timely sample flow and support for batch disposition and regulatory submissions (e.g., FDA Center for Veterinary Medicine (CVM) Investigational New Animal Drug (INAD) applications and eventual New Animal Drug Applications (NADA)). Stay current with evolving FDA CVM, USP, ICH, and company SOPs related to sample management, stability programs, and clinical material shipment for veterinary advanced therapies. Required Qualifications Education Bachelor's degree in a scientific discipline (Biology, Microbiology, Chemistry, or related field) required. Master's degree is a plus but not required. Experience 2-5 years of hands-on Quality Control or analytical laboratory experience in the biopharmaceutical industry, with direct exposure to cell therapy, gene therapy, or complex biologics testing preferred. Demonstrated experience performing GMP-compliant analytical and microbiological testing, environmental monitoring, and sterility assurance activities in a cleanroom environment. Familiarity with cell-based potency assays, flow cytometry, qPCR, ELISA, or compendial microbiological methods is highly desirable. Experience supporting QC for autologous or allogeneic cell products and/or viral-vector gene therapies is a plus. Skills & Competencies Working knowledge of

U.S. GMP

regulations (21 CFR Parts 210/211), USP compendial methods, ICH guidelines, and risk-management principles as they apply to QC operations. Strong attention to detail, organizational skills, and ability to execute detailed SOPs while maintaining high standards of data integrity in a fast-paced biotech setting. Excellent written and verbal communication; able to clearly document results and contribute to team discussions. Passion for animal health and a collaborative, positive, team-oriented mindset. Preferred Qualifications Direct experience with veterinary biologics or FDA CVM-regulated products. Previous work in a startup or small-biotech environment. Professional certifications or aseptic processing/sterile manufacturing training are advantageous but not required.

Most Important Qualities:

Strong communication skills, both written and verbal Easily adapts to change, enjoys a dynamic environment Willingness to learn High integrity, genuine Entrepreneurial spirit Remarkable discipline and organization Great attention to detail High speed of execution Strong work ethic Resourcefulness, ability to get things done on your own despite obstacles Ability to receive and incorporate feedback Passion for service Great at conflict resolution Consistently positive attitude Loves cats, dogs and horses! Work Environment This is a full-time, on-site position based at our cGMP manufacturing facility. The role requires hands-on presence in the QC laboratory and on the manufacturing floor during production campaigns, including occasional off-shift or weekend support as dictated by the manufacturing and testing schedule. All duties will be performed in strict compliance with FDA regulations related to the manufacture of cell and gene therapy products for veterinary medicine, including current Good Manufacturing Practice (cGMP) and CVM-specific guidance. The QC Analyst plays a critical role in ensuring the safe, compliant, and reliable production of advanced veterinary therapies.

Job Type:

Full-Time We are an equal opportunity employer committed to advancing safe and effective veterinary cell and gene therapies in full accordance with FDA/CVM standards.

Pay:

$55,000.00 - $78,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Application Question(s): Tell us why you are a fit for the position.

Work Location:

In person