Director, Assembly and Packaging Platform

Role Overview

• Provide strategic and scientific leadership for the development, commercialization, and lifecycle stewardship of pharmaceutical and combination ‑ product packaging platforms.
• Ensure robust technical execution, compliant global submissions, and optimized manufacturing performance through expert guidance, risk management, and cross ‑ functional collaboration.
• Lead, mentor, and develop a team of technical staff, fostering a culture of continuous improvement.
• Provide subject matter expertise and ensure scientific rigor, technical problem solving, and execution excellence across the assembly and packaging platform portfolio.
• Develop and execute robust technical plans across device assembly, packaging, and/or distribution and logistics of finished goods images.
• Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
• Provide technical guidance to investigations and lifecycle changes for packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards.
• Provide technical guidance to platform standards for standard finished goods images and packaging and assembly equipment standards.
• Drive continuous improvement initiatives.
• Develop and maintain strong relationships with internal stakeholders to facilitate effective technical support and platform stewardship.
• Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities.
• Provide strategic leadership and direction for technical support across the platform stewardship teams.

Requirements

• Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years of required experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR MS with twelve (12) years OR PhD with eight (8) years
• Subject matter expertise in medical device and combination product (MDCP) assembly and packaging, including primary and secondary packaging formats such as bottles, blisters, and prefilled syringes (PFS), with experience spanning process development, scale-up, validation, and commercialization.
• Experience leading or supporting global technical transfers of combination product assembly and packaging processes, including scale-up, PPQ readiness, and cross-site implementation.
• Demonstrated experience in a leadership role; managing technical teams supporting packaging as well as combination product assembly & packaging.
• Strong technical problem-solving capability with experience in root cause analysis, process optimization, and troubleshooting of automated or high-speed assembly and packaging systems, including integration of device and packaging processes.
• In-depth knowledge of global regulatory requirements and design controls for medical devices and combination products, including integration of device design, packaging performance, and regulatory submissions (e.g., human factors, extractables/leachables, stability considerations).
• Strong technical knowledge of automated and semi-automated assembly systems, including AI-enabled inspection technologies, vision systems, and smart manufacturing solutions supporting combination product assembly and packaging.
• Demonstrated expertise across diverse packaging formats and materials, including rigid containers, blister systems, and injectable device formats, with understanding of material compatibility, sterility assurance, and product integrity requirements.
• Strong understanding of risk management principles, including ISO14971 and other relevant standards.
• Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support and product stewardship.
• Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.

Tech Stack

• Assembly

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days