Director, Combination Products Packaging Engineering Technical Leadership

Job Description

Reporting into the Director Packaging Platform Leadership the Director Medical Device and Combination Product (MDCP) Packaging Platform Technical Leadership will be responsible and accountable for technical support and stewardship of key packaging and assembly platforms including components, processes, and equipment.  The steward organization is responsible for establishing and maintaining the MDCP platform standards for one or more packaging platforms including the standard finished goods images as well as packaging and assembly equipment standards.  The Director will lead a team of cross functional technical experts to ensure the development and execution of robust technical lifecycle management plans including proactive risk management strategies, and continuous improvement initiatives to guarantee the safety, effectiveness, and compliance of our company's product portfolio across the internal and external network including device assembly, packaging and/or distribution and logistics of the finished goods images.

The successful candidate will have organizational, technical, and project leadership experience commensurate with leading a global, cross-modality technical team. The leader will also be responsible for executing on priorities for the organization and the successful completion of projects, through strong scientific excellence, technical rigor, robust problem solving and strategic decision making. The candidate will be expected to build inclusive, collaborative partnerships with internal and external stakeholders such as packaging and manufacturing sites, device development and technology, analytical, regulatory and project leaders.  The successful candidate will display ownership and make informed cost/benefit decisions based on analysis of inputs, outcomes, risks, and company-wide prioritization.

Essential Responsibilities:

• Provide strategic leadership and direction for technical support and packaging platform stewardship, including managing ongoing changes and tech transfers for the components, equipment, and processes.  Develop, maintain, and refine technical platform lifecycle management plans, setting and managing and optimizing platform standards.
• Collaborate with cross-functional teams and stakeholders to ensure that all platforms (e.g. syringes, auto injectors, kits) meet safety, efficacy, quality, and robust supply standards.
• Oversee lifecycle changes for MDCP packaging platforms ensuring internal technical requirements are achieved and ensure filings with regulatory bodies to ensure compliance with relevant regulations and standards.   Ensure thorough engineering and packaging science is applied to deliverables for new product introductions and tech transfers across the network inclusive of aligning the control and validation strategies.
• Drive scientific rigor, technical problem solving and execution excellence including interrogation of the data/ science through technical reviews and exploring alternative ways to view and solve problems to achieve results.
• Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.
• Develop and maintain strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, Technical Product Leaders, and Value Chain to facilitate effective technical support and platform stewardship.  This includes above site support for significant investigations, complaints monitoring and rapid response activities.
• Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of technical platform stewardship activities.  Manage the portfolio of work in the platform, holding the team accountable to deliver on priorities

Minimum Education Requirements and Experience:

• 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