United States Remote (Country) Employment

EX Squared is hiring a Director, Packaging Engineering (Remote - US)

About the Role

A confidential opportunity exists for a Leadership Role in Pharmaceutical Packaging Engineering within the United States. This executive position demands comprehensive oversight of packaging engineering for oral solid dosage products, encompassing comprehensive project management from initial development through commercial implementation. The role involves strategic guidance of packaging process development, validation protocols, and launch readiness while maintaining rigorous regulatory compliance and operational excellence. Key responsibilities include: · Pioneering packaging process development, scaling, optimization, and comprehensive validation for oral solid dosage products. · Strategically managing contract manufacturing partner selection through technical evaluations, audits, and operational governance. · Supervising packaging launch preparedness, including intricate labeling, artwork creation, serialization, and distribution requirements. · Establishing robust commercial packaging operations ensuring sustained efficiency and regulatory adherence. · Developing regulatory submission documentation addressing container closure systems and process specifications. · Executing packaging component qualification and comprehensive stability assessments. · Resolving packaging challenges through systematic root-cause investigations and corrective interventions. · Implementing continuous improvement strategies across packaging ecosystems. · Facilitating cross-functional collaboration to synchronize packaging readiness objectives. Candidate Requirements: · Advanced degree in Packaging, Chemical, Mechanical, or Materials Engineering · Minimum 10 years pharmaceutical packaging engineering experience · Extensive expertise in packaging technologies and systems · Demonstrated success in process development and validation · Exceptional CDMO/CMO partnership management capabilities · Comprehensive understanding of global regulatory frameworks · Proficient in risk assessment and corrective action methodologies · Exceptional project leadership and collaborative skills · Adaptable to dynamic, mission-driven environments Comprehensive Compensation Package: · Salary Range: $180,000 - $240,000 · Comprehensive health coverage · $1,000 home office equipment allowance · $1,200 annual professional development budget · $250 monthly wellness stipend · Flexible vacation policy · Unique pet adoption leave · Equity participation opportunities · Inclusive workplace environment Talent matching platform utilizing advanced AI-driven screening processes will evaluate candidate profiles, comparing skills, experience, and achievements against role-specific requirements to identify top candidates efficiently and objectively. #LI-CL1

Required Skills
Packaging EngineeringPharmaceutical Regulatory ComplianceCDMO/CMO ManagementProcess ValidationSerializationRisk AssessmentProject LeadershipCross-functional CollaborationQuality SystemsRoot Cause Analysis
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About company
EX Squared

Technology company focused on IT and software solutions

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Job Details
Category management
Posted 4 months ago