Director, Engineering, Logistics & Distribution Technology

Director, Packaging Shipping Systems (Logistics And Distribution Technology)

Reporting into the Director Packaging Distribution, Components and Systems COE the Director, Logistics and Distribution Technology will be responsible and accountable for subject matter expert technical support for distribution and logistics of human health Drug Substance, Drug Product and Finished Goods globally. 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 Logistics and Distribution Technology Director is integral to this mission. 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 providing Logistics and Distribution Technology Center of Excellence support to the enterprise. The leader will be responsible for executing the organization's priorities and ensuring the successful completion of projects. This includes technical support to the internal and external manufacturing sites as well as Third Party Logistics providers to ensure robust, compliant distribution of products through guidance on distribution qualification activities for shock and vibration as well as thermal protection system testing and qualification and leading execution of qualification of complex systems. In addition, characterizing the real-world distribution experience to enable translation into standard work development for distribution related characterization across packaging platforms to ensure protective packaging designs.

The candidate is expected to build inclusive, collaborative partnerships with internal and external stakeholders, such as packaging and 3rd party logistics sites, supply chain and technology teams, and 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 portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and solve problems to achieve results.

+ Provide strategic leadership and direction for development of standard work to characterize the real-world distribution environment, and to translate that into distribution related characterization of packaging systems.

+ Ensure thorough engineering and distribution packaging science is applied to deliverables for new product introductions and technology transfers across the network.

+ Deliver the development, design, construction, qualification/ validation and/or initial operation of complex tertiary packaging components and processes, including environmental (temperature, shock, etc.) monitors, using new or existing technologies for new and commercial human health products including active pharmaceutical ingredients, drug substance, drug product, finished goods including combination products, and samples.

+ 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 platforms meet safety, efficacy, quality, and robust supply standards.

+ Develop and maintain strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory, manufacturing, and Supply Chain to facilitate effective technical support. 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 COE support. Manage a portfolio of work, holding the team accountable to deliver on priorities.

+ Remain informed of current Good Manufacturing Practices, cGMP, and Good Distribution Practices, cGDP, and requirements and industry trends as described in worldwide regulations and industry standards.

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 of relevant experience in 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 of relevant experience in 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 of relevant experience in pharmaceutical packaging, combination product assembly and packaging, or related technical fields.

Required Skills And Experience

+ Subject matter expertise in distribution technologies (e.g. cold-chain, thermal protection systems, temperature profiles, monitoring technologies, shock, and vibration), processes and operations across internal and external partners and third-party logistics providers. Subject matter expertise in development and qualification of package design and/or distribution/ transportation technologies for pharmaceutical products including parenteral and/or medical device and combination products.

+ Demonstrated experience in a leadership role, managing technical team in support of packaging or distribution operations, or related functions.

+ Strong problem-solving and decision-making skills with an ability to interrogate the science, identify true requirements, and detect critical flaws including ability to determine areas of potential risk, generate gap analysis and mitigation strategies

+ In-depth knowledge of global regulatory requirements for distribution including good distribution practices.

+ Able to guide key activities including development of standard work, investigations, and problem solving.

+ Strong strategic and analytical thinking, with a focus on driving continuous improvement and implementing best practices in technical support.

+ Excellent communication and interpersonal skills, with the ability to effectively engage with internal and external stakeholders.