Senior Advisor, Manufacturing Package Design

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Act as the manufacturing/CMC packaging design lead on project teams with external CMOs/CPOs, representing the company effectively.

• Manage technical relationships related to packaging, including conducting periodic site visits.

• Collaborate with CMC and Clinical Supply Chain on packaging and labeling for clinical trials, aligned with production forecasts and product demand.

• Direct packaging engineering efforts, encompassing design verification/validation, transportation and shipping validation, stability packaging configurations, and compatibility studies.

• Facilitate the transfer of packaging designs 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 compliance with cGMP and design control requirements.

• Write and review CMC packaging sections for regulatory submissions, responding to inquiries from health authorities regarding packaging.

• Collaborate with Manufacturing, Quality, Supply Chain, and Commercial teams to ensure launch readiness, commercial supply continuity, and effective product lifecycle management.

• Spearhead continuous improvement initiatives aimed at enhancing packaging processes, equipment, and vendor performance.

• Oversee packaging-related change controls, deviations, and CAPAs; assist in root cause investigations.

• Assess and select packaging materials, components, and equipment while supporting supplier and packaging line qualifications.

• Provide expertise in packaging design for quality systems, processes, and procedures.

• Build, lead, and mentor a team dedicated to manufacturing package design activities.

• Offer subject matter expertise during regulatory inspections and audits.

⛳️ Requirements

• Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related discipline.

• Over 7 years of experience in manufacturing package design from the sponsor's perspective.

• Proven leadership in managing packaging design programs.

• Extensive experience in supporting late-stage clinical and/or commercial packaging programs.

• In-depth knowledge of cGMP regulations and industry standards/trends related to pharmaceutical packaging design, container closure systems, and manufacturing.

• Demonstrated experience in leading packaging technical strategy and design for late-stage/commercial programs, including technology transfer to commercial manufacturing.

• Experience in managing relationships with CMOs/CPOs and suppliers of packaging components/materials.

• Proficient understanding 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 abilities.

• Proven capability to identify and resolve packaging-related technical or quality issues that may impact schedule, supply, or overall program success.

• An advanced degree is preferred.

• Experience in authoring or reviewing CMC packaging sections of regulatory submissions is preferred.

• Familiarity with combination products/device packaging is preferred, as applicable.

• Willingness to travel domestically and internationally approximately 10–20% of the time.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug benefits.

• Flexible spending accounts for healthcare and/or dependent day care.

• Life insurance and death benefits.

• Paid time off and leave of absence benefits.

• Employee assistance program.

• Fitness benefits.

• Opportunities for employee clubs and activities.