Associate Director, Manufacturing Package Design

Associate Director, Manufacturing Package Design

We are currently seeking an Associate Director, Manufacturing Package Design. This individual will lead the design, development, and technical strategy for primary and secondary packaging supporting late-stage clinical and commercial-stage drug product manufacturing. Reporting to the Vice President, CMC, this role will provide technical and strategic leadership for packaging systems, ensuring solutions meet quality, regulatory, and commercial manufacturing readiness requirements. This individual will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, and Supply Chain, as well as external Contract Manufacturing/Packaging Organizations (CMOs/CPOs), to drive packaging design, qualification, and launch readiness for late-stage development programs.

Key Responsibilities

• Lead the design, development, and technical strategy for primary and secondary packaging components/ systems for small molecule solid oral dosage forms (e.g., container closure systems including bottles and blisters, and blister wallet configurations where applicable) supporting late-stage clinical and commercial manufacturing programs.
• Serve as the manufacturing/CMC packaging design lead representing the company on project teams with external CMOs/CPOs; manage packaging-related technical relationships, including periodic site visits as required.
• Partner with CMC and Clinical Supply Chain to ensure proper clinical trial packaging and labeling are 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, including line trials, engineering runs, and scale-up activities.
• Develop and maintain technical documentation supporting packaging design (e.g., design history files, packaging specifications, risk assessments/FMEAs) in accordance with cGMP and applicable design control requirements.
• Partner with Regulatory Affairs to author and review CMC packaging sections of regulatory submissions and respond to health authority queries related to packaging.
• Collaborate with Manufacturing, Quality, Supply Chain, and Commercial teams to ensure packaging design supports launch readiness, commercial supply continuity, and product lifecycle management.
• Identify, lead, and implement continuous improvement initiatives for packaging processes, equipment, and vendor performance to achieve sustainable, scalable manufacturing performance.
• Manage packaging-related change controls, deviations, and CAPAs in collaboration with Quality; support root cause investigations related to packaging design or component performance.
• Evaluate and select packaging materials, components, and equipment in partnership with CMOs/CPOs and suppliers; support qualification of new suppliers and packaging lines.
• Provide packaging design expertise in support of the development of quality systems, processes, and procedures.
• Build, lead, and mentor a team supporting manufacturing package design activities (scope dependent on level).
• Provide subject matter expertise and support during regulatory inspections and audits related to packaging design and engineering.
• Domestic and international travel required (approximately 10–20%).

Qualifications

• Bachelor's degree in packaging engineering, mechanical engineering, materials science, chemistry, life sciences, or a related field; advanced degree preferred.
• 8-10 years' experience in sponsor-side manufacturing package design, with demonstrated leadership of packaging design programs. Significant experience supporting late-stage clinical and/or commercial packaging programs required.
• 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.
• Experience authoring or reviewing CMC packaging sections of regulatory submissions preferred.
• Experience with combination products/device packaging preferred, as applicable.
• Strong leadership, project management, and cross-functional collaboration skills; exercises judgment within broadly defined practices and policies in determining solutions and actions.
• Demonstrated ability to identify and address packaging-related technical or quality issues that could jeopardize schedule, supply, or overall program success.

Compensation

The annual base salary range for the Associate Director…