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Loyal · 2 weeks ago

Sr. Principal, Packaging Engineering

United States

Full-time

Remote

Senior Level, Lead/Staff

$180K/yr - $240K/yr

10+ years exp

Loyal is a clinical-stage veterinary medicine company focused on extending the lifespan and healthspan of dogs. They are seeking a Sr. Principal, Packaging Engineering to lead packaging process development, qualification, validation, and commercial supply for their oral solid dosage products while ensuring compliance and efficiency in packaging operations.

BiotechnologyPetVeterinary

Comp. & Benefits

Responsibilities

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

Qualification

Packaging EngineeringOSD ProductsPackaging Validation (IQ/OQ/PQ)CDMO/CMO ManagementRegulatory SubmissionsRisk Assessments (FMEA)Cross-functional CollaborationVeterinary Products ExperienceContinuous ImprovementProject Leadership

Required

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