Senior Advisor, Manufacturing Package Design

Eli Lilly and Company

. Lead the design, development, and technical strategy for primary and secondary packaging systems for small molecule solid oral dosage forms .

Posted 11/5/2026full-timeRemote • United StatesSenior💰 $144,000 - $250,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in packaging design and development for pharmaceutical applications, with a strong focus on cGMP compliance, regulatory submissions, and cross-functional collaboration. Proven leadership in managing packaging technical strategies and relationships with external partners to ensure successful project execution.

Highest-signal resume keywords

Packaging Design LeadershipCGMP Regulations KnowledgeRegulatory Submissions ExperienceCross-Functional CollaborationProject Management Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Packaging EngineeringDesign Verification/ValidationTechnology TransferRisk AssessmentsFMEAsPackaging SpecificationsStability Packaging ConfigurationsCompatibility StudiesChange Control ManagementQuality Systems Expertise

Soft Skills

LeadershipMentoringCollaborationProblem-SolvingCommunication

Industry Keywords

Pharmaceutical PackagingContainer Closure SystemsClinical Trial PackagingManufacturing Package DesignLate-Stage Clinical ProgramsCommercial ManufacturingPackaging Materials EvaluationSupplier QualificationCAPAsRegulatory Inspections

About the role

Key responsibilities & impact

Lead the design, development, and technical strategy for primary and secondary packaging systems for small molecule solid oral dosage forms
Represent the company as manufacturing/CMC packaging design lead on project teams with external CMOs/CPOs
Manage packaging-related technical relationships, including periodic site visits
Partner with CMC and Clinical Supply Chain on clinical trial packaging and labeling aligned with production forecasts and product demand
Direct packaging engineering activities, including design verification/validation, transportation and shipping validation, stability packaging configurations, and compatibility studies
Lead technology transfer of packaging design and processes from development/clinical scale to commercial manufacturing
Conduct line trials, engineering runs, and scale-up activities
Develop and maintain design history files, packaging specifications, risk assessments, and FMEAs in accordance with cGMP and design control requirements
Author and review CMC packaging sections of regulatory submissions and respond to health authority packaging queries
Collaborate with Manufacturing, Quality, Supply Chain, and Commercial teams on launch readiness, commercial supply continuity, and product lifecycle management
Lead continuous improvement initiatives for packaging processes, equipment, and vendor performance
Manage packaging-related change controls, deviations, and CAPAs; support root cause investigations
Evaluate and select packaging materials, components, and equipment; support supplier and packaging line qualification
Provide packaging design expertise for quality systems, processes, and procedures
Build, lead, and mentor a team supporting manufacturing package design activities
Provide subject matter expertise during regulatory inspections and audits

Requirements

What you’ll need

Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field
7+ years’ experience in sponsor-side manufacturing package design
Demonstrated leadership of packaging design programs
Significant experience supporting late-stage clinical and/or commercial packaging programs
Strong knowledge of cGMP regulations and industry standards/trends pertaining to pharmaceutical packaging design, container closure systems, and manufacturing
Demonstrated experience leading packaging technical strategy and design for late-stage/commercial programs, including technology transfer to commercial manufacturing
Experience managing relationships with CMOs/CPOs and packaging component/material suppliers
Working knowledge of drug substance, drug product, and packaging principles, equipment, and processes across solid dosage and/or parenteral formats
Strong leadership, project management, and cross-functional collaboration skills
Demonstrated ability to identify and address packaging-related technical or quality issues that could jeopardize schedule, supply, or overall program success
Advanced degree preferred
Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred
Experience with combination products/device packaging preferred, as applicable
Domestic and international travel required approximately 10–20%

Benefits

Comp & perks

Company bonus depending in part on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Employee assistance program
Fitness benefits
Employee clubs and activities