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Loyal Logo Loyal · Manufacturing

Principal, Packaging Engineering

United States 180000.00 - 240000.00 USD / Year · Job Posted December 10, 2025
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Job Description

Lead all aspects of packaging process development, qualification, validation, launch readiness, and commercial supply for Loyal’s small molecule, oral solid dosage (OSD) products. 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).

Job Responsibility

  • 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

Requirements

  • 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

Nice to have

  • Experience with veterinary or animal health manufacturing
  • Passion for Loyal’s mission to bring science-driven longevity therapeutics to dogs

What we offer

  • 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 - All Job Offers

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