Assoc. Dir., Engineering, Combination Products Platform Assembly and Packaging Technical Leadership

Associate Director Medical Device And Combination Product Platform Packaging And Assembly Technical Leadership

Reporting into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) Platform Packaging and Assembly 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 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 Associate Director of MDCP Platform Packaging and Assembly Technical Leadership is integral to this mission. The successful candidate will possess deep technical expertise in assembly and packaging of MDCP, 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.

As an individual contributor, the associate director will lead cross-functional teams. The leader 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, device development and technology teams, supply chain, operations, quality, analytical, regulatory, and project leaders. The successful candidate will demonstrate ownership and make informed cost / benefit decisions based on the analysis of inputs, outcomes, risks, and company-wide prioritization.

Essential Responsibilities :

• Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence across the MDCP assembly and packaging platform portfolio, 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.
• Collaborate with cross-functional teams to ensure that all platforms (e.g. syringes, auto injectors, kits) meet safety, efficacy, quality, and robust supply standards.
• Develop and maintain strong relationships with internal stakeholders, including packaging 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.
• Manage the portfolio of work in the platform, holding the cross functional team accountable to deliver on priorities
• Provide strategic leadership and direction for technical support and MDCP packaging & assembly 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.
• 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, medical device 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.

Minimum Education Requirements and Experience :

Required Skills and Experience :