Associate Director, Logistics and Distribution Technology

Job Description

Reporting into the Director, Logistics and Distribution Technology the Associate 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, experimental design and execution, along with leadership skills to shape the technical capabilities lead a global, cross-modality technical team.

The Associate 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.

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.

• 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.

• Analyze complex problems using critical thinking and laboratory experiments to create effective shipping solutions to maintain temperature control and physical protection.

• Provide subject matter expertise and ensure scientific rigor, technical problem solving and execution excellence in support of the portfolio of work, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and solve problems to achieve results.

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

• Drive proactive risk management activities, including risk assessment, risk mitigation, and risk communication strategies.

• Collaborate with cross-functional teams to evaluate processes and shipping systems, resolving excursion issues, and implementing corrective actions.

• Develop and maintain strong relationships with internal stakeholders, including commercialization, quality, analytical, regulatory, manufacturing, and Supply Chain to facilitate effective technical support.

• Manage a portfolio of work, holding the team accountable to deliver on priorities.

• Document preparation, maintenance, and review of documentation including specifications, testing protocols, testing reports, technical memos and supplier assessments

• 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 twelve (12) 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 ten (10) 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…