Position Summary
Director, Head of Manufacturing Operations will lead all aspects of clinical and commercial manufacturing for our cell and gene therapy programs. This senior leadership role will oversee day-to-day operations at our CGMP manufacturing facility, drive scale-up and tech transfer activities, and ensure reliable, compliant production of high-quality veterinary therapies. The ideal candidate will bring deep expertise in aseptic processing of advanced therapies and a proven ability to transition products from clinical supply to commercial readiness in a risk-based, phase-appropriate manner. This position reports to the Chief Technical Officer (or equivalent) and will work closely with Quality, Process Development, Regulatory Affairs, and Clinical teams.
Key Responsibilities
- Lead and optimize clinical and commercial manufacturing operations for cell and gene therapy products, including autologous/allogeneic cell processing and viral vector production.
- Oversee cGMP manufacturing activities, batch production, scheduling, and facility operations to meet clinical supply and commercial demand timelines.
- Manage tech transfer, process validation, scale-up, and continuous improvement initiatives while applying phase-appropriate, risk-based principles.
- Ensure all manufacturing operations comply with FDA regulations, including current Good Manufacturing Practice (cGMP) and FDA Center for Veterinary Medicine (CVM) guidance for veterinary biologics and advanced therapies.
- Lead aseptic process execution, environmental monitoring, and sterility assurance programs in classified cleanrooms.
- Build, mentor, and lead a high-performing Manufacturing team, including hiring, training, and performance management.
- Collaborate cross-functionally to support regulatory submissions (INAD/NADA), deviation investigations, CAPA implementation, and change control.
- Drive operational excellence through metrics, capacity planning, supply chain coordination, and cost-of-goods optimization.
- Prepare for and support regulatory inspections (FDA CVM and others) and internal audits.
- Implement robust safety, training, and documentation systems to maintain a compliant and efficient manufacturing environment.
Required Qualifications
Education
- Bachelor’s or Master’s degree in a scientific or engineering discipline (Biology, Biochemistry, Chemical Engineering, or related field) required. Advanced degree (MS/MBA) is preferred but not required.
Experience
- Minimum 10 years of progressive experience in biopharmaceutical manufacturing, with at least 6 years in cell therapy, gene therapy, or complex biologics.
- Demonstrated success leading manufacturing operations for clinical and/or commercial production of advanced therapies.
- Strong hands-on background in aseptic processing, cleanroom operations, and GMP-compliant production of sterile biologics.
- Prior experience scaling manufacturing processes from clinical to commercial stages.
- Leadership experience managing manufacturing teams in a cGMP facility.
Skills & Competencies
- Thorough knowledge of FDA cGMP regulations (21 CFR Parts 210/211, 600 series) and CVM-specific guidance for veterinary cell and gene therapies.
- Expertise in risk-based manufacturing, process validation, and technology transfer.
- Strong problem-solving, decision-making, and project management skills.
- Excellent communication and collaboration abilities with the ability to influence cross-functional teams.
- Passion for animal health and commitment to delivering high-quality therapies for pets.
Preferred Qualifications
- Prior work in startup or small-biotech environments.
- Knowledge of single-use systems, closed processing, and automation for cell/gene therapy manufacturing.
- Professional certifications in GMP, lean manufacturing, or related areas are a plus.
Location & Work Environment
This is a full-time, on-site position based at our cGMP manufacturing facility. The role requires hands-on presence on the manufacturing floor during production campaigns, including occasional off-shift or weekend support as dictated by the manufacturing 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 Head of Manufacturing Operations plays a critical role in ensuring the safe, compliant, and reliable production of advanced veterinary therapies.
We are an equal opportunity employer committed to advancing safe and effective veterinary cell and gene therapies in full accordance with FDA/CVM standards.
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.
Pay: From $200,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- Can you tell us why you would be a good fit for the role?
Experience:
- biopharmaceutical manufacturing: 10 years (Required)
Work Location: In person
