Director, Packaging Engineering

About Loyal

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Our mission is to help dogs live longer, healthier lives.

We’ve already achieved significant milestones on our path to earning FDA approval for the first lifespan extension drug for any species. We have three products in our pipeline and are on track for FDA conditional approval within the next year.

Loyal is a well-funded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. This role will play a key role in supporting our growth strategies.

About the role

We’re seeking an experienced Director, Packaging Engineering to 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.

The ideal candidate brings deep expertise in OSD packaging engineering, strong experience with external packaging and manufacturing partners, and the ability to deliver packaging strategies and solutions that meet regulatory, technical, operational, and commercial requirements. Experience with veterinary products is a plus but not required.

This role reports to the Vice President, Manufacturing.

Your daily work will include

• Lead packaging process development, scale-up, and optimization for OSD drug products.
• Drive CDMO/CMO selection, including technical evaluations, audits, contracting, and governance for packaging operations.
• Develop and refine packaging processes, ensuring robustness, manufacturability, and compliance with regulatory and product requirements.
• Lead packaging qualification and validation (IQ/OQ/PQ) for launch and commercial readiness.
• Oversee packaging launch readiness, including artwork, labeling, serialization, child-resistant/senior-friendly requirements, packaging components, and distribution-related packaging needs.
• Establish and oversee commercial packaging operations, ensuring efficiency, compliance, and long-term supply continuity.
• Author and contribute to packaging-related sections of regulatory submissions (Module 3), including container closure system documentation, packaging process descriptions, and responses to regulatory queries.
• Support or participate in PAIs and other regulatory interactions related to packaging.
• Conduct and oversee packaging component qualification, compatibility studies, and packaging-related stability evaluations.
• Troubleshoot packaging issues, conduct root-cause investigations, and lead CAPAs.
• Drive continuous improvement across packaging operations, materials, and systems.
• Collaborate cross-functionally with Manufacturing, Quality, Supply Chain, Regulatory, Formulation, and Analytical Development to ensure packaging readiness across all development and commercial stages.

About you

• Bachelor’s, Master’s, or PhD in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, or a related field.
• 10+ years of experience in pharmaceutical or biopharmaceutical packaging engineering, with significant experience supporting commercial or late-stage OSD products.
• Deep expertise in small molecule, oral solid dosage packaging, including bottling, blister packaging, labeling, serialization, and container–closure systems.
• Proven success leading packaging process development, scale-up, qualification, and validation (IQ/OQ/PQ).
• Strong experience with CDMO/CMO selection, technical transfer, and day-to-day management for packaging operations.
• Experience supporting commercial packaging operations, including launch readiness and ongoing supply.
• Demonstrated ability to author packaging sections of regulatory submissions (e.g., Module 3) and respond to packaging-related regulatory questions.
• Strong understanding of global packaging regulatory expectations (FDA, EMA, ICH), including CR/SF requirements and serialization/traceability standards.
  Experience with packaging component qualification, compatibility studies, and packaging-related stability requirements.
• Experience supporting or participating in pre-approval inspections (PAIs) related to packaging.
• Demonstrated excellence in risk assessments (FMEA) and