Job Description
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 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 Analyst will perform hands-on Quality Control testing and laboratory activities for our pet-specific cell and gene therapy programs. Reporting to the Manager, Quality Control, this laboratory-based role will execute phase-appropriate QC assays and procedures that ensure full compliance with current Good Manufacturing Practices (cGMP) and applicable veterinary regulatory requirements. The ideal candidate will bring strong technical expertise in analytical, microbiological, and environmental testing for cell and viral-vector manufacturing, combined with meticulous attention to detail and a pragmatic, compliant approach suitable for both early clinical and late-stage commercial readiness. This is a key individual-contributor role that will support quality culture and enable rapid, compliant advancement of our novel therapies for pets. Key Responsibilities Execute in-process, release, and stability testing programs (identity, purity, potency, safety, sterility, endotoxin, bioburden, and microbial testing) for stem cell and viral-vector based products in accordance with cGMP, SOPs, and FDA CVM guidance. Perform environmental monitoring (viable/non-viable particle counting, surface and air sampling) in ISO-classified cleanrooms and support media fill programs and sterility assurance activities. Accurately document all testing activities, results, and observations in laboratory notebooks, electronic systems, batch records, and certificates of analysis. Assist in the investigation of out-of-specification (OOS) results, laboratory deviations, and environmental excursions; support implementation of corrective and preventive actions (CAPA) as assigned. Support QC method qualification, validation, and transfer activities for advanced therapy products. Prepare and maintain QC reagents, standards, controls, and laboratory inventory; perform routine equipment calibration and maintenance. Collaborate cross-functionally with Manufacturing, Process Development, Quality Assurance, and Regulatory Affairs teams to ensure timely delivery of compliant QC data 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)). Participate in internal audits, supplier/CMO testing oversight activities, and regulatory inspection readiness as required. Perform risk assessments and support mitigation strategies for QC testing and stability activities per ICH Q9 and FDA guidance. Stay current with evolving FDA CVM, USP, ICH, and international guidelines specific to QC testing of 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 - $65,000.00 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 think you are a good fit for this role. Work Location:
In person
