Loyal

The CMC Quality Manager, Analytical, provides quality oversight and technical leadership for analytical development and testing activities supporting veterinary pharmaceutical products under FDA Center for Veterinary Medicine (CVM) guidance. This role ensures that analytical methods, stability programs, and product testing are scientifically sound, validated, and compliant with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and applicable regulatory expectations.

Lead all aspects of packaging process development, qualification, validation, launch readiness, and commercial supply for Loyal’s small molecule, oral solid dosage (OSD) products. This role is responsible for packaging operations across the entire product lifecycle — from development through commercial execution — and will drive CDMO selection and management, packaging process development, packaging line readiness, and packaging validation (IQ/OQ/PQ). You will ensure that Loyal’s packaging systems are robust, compliant, and ready to support product launch and ongoing commercial supply.

Lead all aspects of drug product (DP) manufacturing and packaging operations for Loyal’s small molecule, oral solid dosage (OSD) programs, as this role is essential to ensuring late-stage manufacturing execution, product launch readiness, commercial manufacturing oversight, and long-term supply continuity. The VP of Manufacturing will guide internal and external teams through process validation, PPQ, commercial technology transfer, packaging validation.

Seeking an experienced Senior Director, Technical Operations to provide technical leadership across all CMC disciplines as programs advance from early development through commercialization, including preparations for upcoming product launch. This role serves as a cornerstone of the Technical Operations organization, ensuring connectivity, scientific rigor, and technical excellence across process, analytical, and formulation development, manufacturing, and supply.

Responsible for building and leading cross-functional quality assurance systems across Loyal teams with an emphasis on FDA-CVM regulatory compliance for drug submissions and products. The work will ensure that all aspects of drug development and clinical operations are high quality, and that any deviations from this are investigated and understood. You will report to our VP of Regulatory and QA.

The Clinical Quality Specialist will own data quality generated in Loyal’s pre-clinical and clinical studies. They are responsible for implementing quality assurance and quality control processes to ensure studies are conducted and data are generated, documented, and reported in compliance with applicable protocols, GLP, GCP, and regulatory requirements. This role will participate in quality initiatives, collaborating with cross functional teams.

Responsible for building and leading cross-functional quality assurance systems across Loyal teams with an emphasis on FDA-CVM regulatory compliance for drug submissions and products. This role ensures all aspects of drug development, manufacturing and clinical operations are high quality, and that any deviations from this are investigated and understood. The Quality Compliance Officer is responsible for maintaining and continuously improving the company’s Quality Management System (QMS).

Partner with the executive team in guiding the company’s financial strategy and operations. Bring deep financial expertise, operational rigor, and strategic insight to support growth, improve financial performance, and prepare the organization for upcoming milestones. Design and implement scalable financial processes.