Principal, Packaging Engineering Jobs

Loyal

Location:
United States

Category:
Manufacturing

Contract Type:
Not provided

Salary:

180000.00 - 240000.00 USD / Year

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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

Additional Information:

Job Posted:
December 10, 2025

Employment Type:

Fulltime

Work Type:

Remote work

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Principal, Packaging Engineering