VP, Manufacturing

VP, Manufacturing

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.

We're seeking an experienced Vice President, Manufacturing to lead all aspects of drug product (DP) manufacturing and packaging operations for Loyal's small molecule, oral solid dosage (OSD) programs.

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, and the establishment of commercial manufacturing operations.

This leader will also oversee drug product process development for early-stage programs, ensuring that processes are scientifically rigorous, scalable, and positioned for smooth transition into late-stage and commercial manufacturing.

In addition, the VP of Manufacturing will author and review manufacturing-related CMC submission sections, lead technical responses to regulatory agencies, and participate directly in regulatory interactions. You will work closely with Quality and Regulatory to prepare for pre-approval inspections (PAIs) and ensure manufacturing and packaging operations meet global regulatory expectations.

This role partners closely with Supply Chain to ensure launch readiness, demand planning, inventory strategy, and commercial supply continuity across Loyal's CDMO network.

This position reports to the Chief Technical Operations Officer.

• Lead all drug product manufacturing and packaging operations from late-stage development through commercial launch and ongoing commercial supply.
• Oversee process validation, PPQ, and commercial technology transfer to commercial manufacturing sites.
• Provide oversight and technical guidance for early-stage drug product process development, ensuring scalable, robust, and well-controlled processes.
• Drive CDMO selection, contracting, and governance, ensuring strong technical performance, quality, and supply reliability.
• Ensure manufacturing and packaging operations meet GMP compliance, process robustness, and global regulatory expectations.
• Author and review manufacturing-related CMC regulatory submissions, including process descriptions, validation summaries, commercial readiness content, and container-closure documentation.
• Lead technical interactions with regulatory authorities, including preparing briefing materials, responding to inquiries, and representing manufacturing during regulatory meetings.
• Support preparation and readiness for pre-approval inspections (PAIs), including technical documentation, training, and site responses.
• Partner with Quality to support technical investigations, root-cause analyses, and CAPA development.
• Contribute to process lifecycle management, including post-approval changes, continued process verification (CPV), and ongoing optimization.
• Partner with Supply Chain on launch readiness, production planning, technical supply risk assessment, and commercial supply continuity.
• Build, mentor, and lead a high-performing team supporting manufacturing, packaging, and technical operations.

• PhD in Chemical Engineering or a closely related discipline preferred; MS / BS candidates with extensive relevant experience will also be considered.
• 15+ years of experience in pharmaceutical / biopharmaceutical manufacturing covering the full product lifecycle early development, late-stage development, product launch, and commercial manufacturing.
• Experience in late-stage manufacturing, product launch, and commercial manufacturing oversight is a must.
• Experience building and scaling commercial manufacturing and packaging capabilities is a must.
• Experience supporting or overseeing early-stage drug product process development.
• Proven expertise in small molecule, oral solid dosage manufacturing, including tech transfer, PPQ, and process validation.
• Strong experience overseeing packaging operations, including packaging readiness and validation.
• Demonstrated ability to author manufacturing-related regulatory submission sections and respond to agency queries.
• Experience participating in or preparing for regulatory inspections, including PAIs.
• Strong understanding of GMP regulations and global manufacturing expectations (FDA, EMA, ICH).
• Experience leading technical investigations, root-cause analyses, and CAPA development.
• Demonstrated…