Director, Assembly and Packaging Platform – Technical Leadership

Role Overview

• Reporting into the Executive Director Packaging Technical Operations the Director Packaging and Assembly Platform Technical Leadership will be responsible and accountable 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 successful candidate will possess deep technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape the technical capabilities and strategic direction for a global, cross-modality technical team.
• The Director will lead a team of technical experts responsible for technical leadership of key packaging and assembly platforms. They will be responsible for executing the organization's priorities and ensuring the successful completion of projects.
• This includes the development and execution of robust technical plans across device assembly, packaging, and/or distribution and logistics of finished goods images, encompassing proactive risk management strategies, platform standards for standard finished goods images and packaging and assembly equipment standards, technical lifecycle management, and continuous improvement initiatives to guarantee the robustness and compliance of our company's product portfolio across the internal and external networks.
• The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and manufacturing sites, packaging & device development and technology teams, supply chain, operations, quality, analytical, regulatory, and project leaders.

Requirements

• Bachelor of Science (BS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with fifteen (15) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields;
• OR Master of Science (MS) in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with twelve (12) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields;
• OR PhD in packaging/ mechanical/ chemical/ biochemical engineering, pharmaceutical science or chemistry or related fields with eight (8) years relevant experience pharmaceutical packaging, combination product assembly and packaging, or related technical fields;
• 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 an ability to determine interrogate the science, identify true requirements, and detect critical flaws including the ability to determine areas of potential risk, generate gap analysis and mitigation strategies.
• In-depth knowledge of global regulatory requirements for medical devices and combination products and packaging.
• Strong understanding of risk management principles, including ISO 14971 and other relevant standards.

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