Loyal

Director – Packaging Engineering

Loyal

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Salary

💰 $180,000 - $240,000 per year

Job Level

Lead

About the role

  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
packaging process developmentscale-uppackaging qualificationvalidation (IQ/OQ/PQ)packaging component qualificationcompatibility studiespackaging-related stability evaluationsrisk assessments (FMEA)packaging investigation methodologies (RCA, CAPA)serialization
Soft skills
cross-functional collaborationproject leadershipexternal partner managementtroubleshootingroot-cause investigationcontinuous improvementeffective communicationproactive approachability to thrive in fast-paced environmentsstrong interpersonal skills