Director, Packaging Distribution, Components and Systems Centers of Excellence (Director, Engineering)

Job Description

Reporting into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for technical leadership, strategic planning and portfolio execution of key work in support of Centers of Excellence for the packaging and device community including logistics and distribution technologies, small molecule bulk and primary packaging components and packaging master data and systems.

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 Distribution, Components and Systems COE is integral to this mission. The successful candidate will possess deep packaging and/or combination product 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 providing Center of Excellence support to the enterprise.  They will be responsible for executing the organization's priorities and ensuring the successful completion of projects. This includes providing SME guidance to the enterprise for logistics and distribution technologies including thermal container qualification from frozen through refrigerated to room temperature shipments, distribution (shock and vibration) qualification, and data collection systems for distribution (e.g. temperature monitors).  To provide SME guidance in support of small molecule drug substance and drug product container closure systems including mold qualification and regulatory compliance.  To act as master data stewards and support enterprise wide component specification management as well as maintaining documentation systems for the packaging community.    The COE teams provide support to life cycle changes, investigations, trouble shooting 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, supply chain, commercialization teams across the end to end supply chain, and 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:

• 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 distribution, component and systems COE 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 and stakeholders to ensure that all solutions (e.g. thermal containers, package designs, new components) meet safety, efficacy, quality, and robust supply standards.

• Develop and maintain strong relationships with internal stakeholders, including supply chain, packaging commercialization, quality, analytical, regulatory, manufacturing, Device Development and Technology, to facilitate effective COE support to the portfolio.  This includes above site support for significant investigations, developing new solutions, establishing guidance and standard work. and maintaining key systems including component specifications.

• Provide strategic leadership and direction for technical support across Centers of Excellence including technical guidance to component or process changes, supporting tech transfers and investigations. 

• Develop and maintain key performance indicators (KPIs) to measure and improve the effectiveness of COE support.   Manage the portfolio of work in the platform, holding the team accountable to deliver on priorities on time and right first time.

• Ensure thorough engineering and packaging science is applied to deliverable