Associate Director, Manufacturing Package Design

We are seeking an Associate Director to lead the design, development, and technical strategy for primary and secondary packaging supporting late-stage clinical and commercial-stage drug product manufacturing. This role reports to the Vice President, CMC and ensures packaging solutions meet quality, regulatory, and commercial manufacturing readiness requirements.

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) 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%).

Requirements

• 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.

Pay

The annual base salary range for this Associate Director level position is $140,000.00 to $210,000.00. Individual compensation within this range will be determined based on qualifications, skills, relevant experience, job knowledge, and location. In addition to base pay, this role is eligible for a discretionary annual bonus.

Benefits

• Comprehensive benefits package, including a 401(k) plan.
• Company-sponsored medical, dental, vision, and life insurance.
• Generous paid time off.
• Health and wellness program.

Schedule

This is a full-time, exempt position based in the US, with occasional travel (approximately 10–20%).