VP, Medical

VP, Manufacturing Loyal Loyal is a clinicalstage 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 have 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 wellfounded startup in growth mode. Our team includes scientists, veterinarians, engineers, operators, and creatives. 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 latestage manufacturing execution, product launch readiness, commercial manufacturing oversight, and longterm 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. The leader will also oversee drug product process development for earlystage programs, ensuring that processes are scientifically rigorous, scalable, and positioned for smooth transition into latestage and commercial manufacturing. In addition, the VP of Manufacturing will author and review manufacturingrelated 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 preapproval 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 latestage development through commercial launch and ongoing commercial supply. Oversee process validation, PPQ, and commercial technology transfer to commercial manufacturing sites. 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 manufacturingrelated CMC regulatory submissions, including process descriptions, validation summaries, commercial readiness content, and containerclosure 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 preapproval inspections (PAIs), including technical documentation, training, and site responses. Partner with Quality to support technical investigations, rootcause analyses, and CAPA development. Contribute to process lifecycle management, including postapproval 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 highperforming team supporting manufacturing, packaging, and technical operations. PhD in Chemical Engineering or a closely related discipline preferred; 15+ years of experience in pharmaceutical/biopharmaceutical manufacturing covering the full product lifecycle early development, latestage development, product launch, and commercial manufacturing. ~ Experience in latestage manufacturing, product launch, and commercial manufacturing oversight is a must. ~ Experience building and scaling commercial manufacturing and packaging capabilities is a must. ~ 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 manufacturingrelated 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, rootcause analyses, and CAPA development. ~ Demonstrated success establishing governance with CDMOs, including technical and quality oversight. ~ Experience with lifecycle management, continued process verification, and postlaunch operations. Experience with veterinary or animal health manufacturing. Passion for Loyal's mission to bring sciencedriven longevity therapeutics to dogs. Fullcoverage health insurance medical, dental and vision for you and your dependents ~$1,000 home office equipment stipend ~$1,200/year learning budget for books, courses, etc. ~$250/month wellness budget for gym, cleaners, spa, food, etc. ~ All 3day weekends are turned into 4day weekends #127881; ~ Unlimited vacation and paid holidays ~ Pawternity leave adopt a dog and get a day off with your new family member #128054; ~ Company equity options grant for new hires Loyal is founded and led by a firstgen female CEO and is proud to be an equal opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law. We have the bravery to take risks and shoot for the impact we want to have.