Director, Packaging Engineering at loyalhealth

, , United States -

Full Time

Start Date

Immediate

Expiry Date

17 Feb, 26

Salary

240000.0

Posted On

19 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Packaging Engineering, Process Development, Qualification, Validation, Commercial Supply, CDMO Selection, Regulatory Compliance, Packaging Operations, Stability Evaluations, Cross-Functional Collaboration, Risk Assessments, Troubleshooting, Continuous Improvement, Project Leadership, Veterinary Products, Oral Solid Dosage

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 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 packaging investigation methodologies (RCA, CAPA). Effective cross-functional collaborator with strong project leadership and external partner management skills. Hands-on, proactive, and thrives in a fast-paced, mission-driven biotech environment. Experience launching packaging operations in a lean or emerging commercial organization. Experience with veterinary or animal health packaging is a plus. 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: $180,000 - $240,000 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 packaging process development, qualification, validation, and commercial supply for small molecule, oral solid dosage products. Ensure packaging systems are robust, compliant, and ready for product launch and ongoing supply.