Director, Engineering, Logistics & Distribution Technology

Job Description

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 organizations 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 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.

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U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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