Director, Engineering Assembly and Packaging Platform Technical Leadership

Overview

Director, Engineering Assembly and Packaging Platform Technical Leadership role orting into the Executive Director Packaging Technical Operations, the Director Packaging and Assembly Platform Technical Leadership is responsible for technical leadership, strategic planning and portfolio execution of key packaging and assembly platforms, with a focus on combination drug products such as prefilled syringes and autoinjectors.

The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Director of Packaging and Assembly Platform Technical Leadership provides deep technical expertise, strong problem-solving capability, strategic acumen, and execution excellence to shape the technical capabilities and strategic direction for a global, cross-modality technical team.

• 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, including data and science reviews and evaluating alternative approaches to meet safety, efficacy, quality, and robust supply standards for platforms (e.g., syringes, autoinjectors, bottles, blisters).
• Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
• Develop and maintain strong relationships with internal stakeholders (packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical Product Leaders, Value Chain) to facilitate effective technical support and platform stewardship, including support for significant investigations, complaints monitoring and rapid response activities.
• Develop and maintain KPIs to measure and improve the effectiveness of technical platform stewardship activities and manage the total platform portfolio of work to deliver on priorities.
• Provide strategic leadership and direction for technical support for the platform stewardship team, including management of ongoing changes and tech transfers for components, equipment, and processes; develop and refine technical platform lifecycle management plans and platform standards.
• Provide technical guidance to lifecycle changes for packaging platforms, ensuring internal technical requirements are met and filings with regulatory bodies for compliance; apply engineering, medical device and packaging science to deliverables for new product introductions and tech transfers across the network, including alignment of control and validation strategies.

• BS in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years of relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields; OR
• MS in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years of relevant experience; OR
• PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years of relevant experience.

• Subject matter expertise in medical device and combination product commercialization and tech transfer, assembly and packaging process improvement and support from early stage through launch and supply, including components, process, and equipment, as well as qualification and validation, medical device design controls and device risk management, and design verification/validation.
• Demonstrated experience in a leadership role; managing technical teams supporting packaging as well as combination product assembly & packaging.
• Strong problem-solving and decision-making skills with ability to interrogate the science,…