VP, Manufacturing at loyalhealth

, , United States -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

320000.0

Posted On

19 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmaceutical Manufacturing, Biopharmaceutical Manufacturing, Process Validation, Commercial Manufacturing, Regulatory Submissions, GMP Compliance, Technical Investigations, Root-Cause Analyses, CAPA Development, Cross-Functional Leadership, Small Molecule Manufacturing, Oral Solid Dosage Manufacturing, Packaging Operations, Lifecycle Management, Supply Chain Management, Team Leadership

Industry

technology;Information and Internet

Description

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 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. Your daily work will include 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. About you 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 success establishing governance with CDMOs, including technical and quality oversight. Effective cross-functional leader with strong communication and collaboration skills. Strategic, hands-on leader who thrives in a fast-paced, mission-driven biotech environment. Experience with lifecycle management, continued process verification, and post-launch operations. Nice to have Experience with veterinary or animal health manufacturing. Passion for Loyal’s mission to bring science-driven longevity therapeutics to dogs — and ultimately humans. Salary range: $270,000 - $320,000 Loyal benefits Full-coverage 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 3-day weekends are turned into 4-day weekends 🎉 Unlimited vacation and paid holidays Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶 Competitive salary Company equity options grant for new hires Loyal is founded and led by a first-gen 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. Our values Lean into moonshots We don’t settle for incremental change. We have the bravery to take risks and shoot for the impact we want to have. Opportunity is at the intersection We lean into combining disciplines, expertises, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos. Expertise without ego Titles do not determine who has a voice. We work on hard technical problems and have a ton of fun while at it. Learning by doing Our path is novel and many things we are doing have never been done before. We lean into MVPs and are open to unexpected outcomes. Lead with context We value leading with context. We equip people with the context and background necessary to make their own decisions and act in the best interest of Loyal. We empower teams to succeed. Empathy and respect for all life Our patients are not just numbers. Our work is intentional, thoughtful, and guided by respect for life. We take our responsibility to pets and pet parents seriously.

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Responsibilities

Lead all aspects of drug product manufacturing and packaging operations from late-stage development through commercial launch. Oversee process validation, commercial technology transfer, and ensure compliance with global regulatory expectations.