Director – Packaging Engineering

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November 20

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Loyal

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Healthcare Insurance • Artificial Intelligence • SaaS

Loyal is a comprehensive digital healthcare platform that integrates various touchpoints for patients and providers. Their solutions include data management, digital engagement, CRM campaigns, self-scheduling, and conversational AI, which are designed to optimize healthcare operations, improve patient engagement, and enhance care search and scheduling. Loyal focuses on making healthcare seamless by unifying provider and location data, managing reputation and directory listings, and offering robust machine learning and natural language processing capabilities to improve healthcare outcomes. The platform facilitates improved communication and retention through omni-channel engagement and feedback analysis, serving prominent healthcare organizations to streamline operations and drive better patient experiences.

51 - 200 employees

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

☁️ SaaS

📋 Description

• 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 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.

🏖️ 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