About This Role:
As a Logistics Engineer, you will be an integral part of the Global Distribution Packaging & Shipping Qualification team, serving as a key Subject Matter Expert (SME) on distribution packaging, cold chain solutions, and shipping qualification. Your role is pivotal in supporting the selection, qualification, and implementation of logistics solutions that address temperature-controlled supply chain needs. You will lead and assist in the design, development, testing, and support of distribution packaging and shipping qualifications for clinical and commercial applications globally. Your contributions will ensure seamless supply chain operations, from critical components to finished goods, across Biogen plants, contract manufacturing organizations, and partners. By developing scientifically valid data and conducting routine analyses, you'll ensure compliance with cGMP requirements and enhance our logistics strategies. Your collaboration with various stakeholders will be essential in addressing business needs and driving innovative solutions.
What You’ll Do:
- Lead mid-to-high complexity improvement projects focused on distribution to enhance capabilities and process efficiency.
- Develop and test complex distribution packaging solutions from design through implementation.
- Develop test strategy for GMP products that will cover global regulatory requirements
- Participate and facilitate Supplier Relationship Management meetings and RFPs, managing vendor relationships.
- Collaborate with key partners within Logistics, Quality, and other departments to proactively address business needs.
- Conduct and oversee lab testing and lane validation activities both internally and externally to ensure compliance and quality standards.
- Support audits, health authority inspections, and regulatory agency inquiries related to shipping qualification.
- Manage Trackwise events, CAPAs, and investigations with a focus on compliance and best practices.
- Support Global Change Controls from a SME perspective and manage timelines of activities
- Provide input on temperature monitoring strategies, tech transfers, and launches.
- Represent the distribution team in cross-functional meetings and provide updates to management. Support technical transfer and launch shipping qualification activities at internal/ external sites and 3PL sites including the shipping, handling, & storage of shipping solutions
- Provide training on cold chain and best practices, guidelines, and regulations across departments including expert advice on the shipping, handling, and storage, and of cold chain solutions.
- Maintain current knowledge of relevant cold chain requirements and monitor emerging industry trends
- Coach and provide guidance to team members, including contractors
Who You Are:
You are an organized, analytical, compliance driven thinker who thrives in fast-paced environments, balancing multiple projects and tasks efficiently. Your natural ability to communicate effectively, both verbally and written, allows you to collaborate seamlessly with senior management and cross-functional teams. You possess a keen eye for detail and demonstrate a drive for results, aiming to make a significant impact in a high-growth, transformational company. Your expertise in logistics and cold chain solutions positions you as a proactive problem-solver, ready to address challenges head-on.
Required Skills:
- BS/BA degree required; BS/BA in Packaging Science/Engineering preferred.
- At least 5 years of experience in packaging, global logistics, or temperature-controlled supply chain.
- Experience in an international and regulated environment with knowledge of packaging standards (ASTM/ISTA) and regulations.
- Experience in testing standards and distribution lab environment
- Strong analytical, problem-solving, and communication skills.
- Exceptional team player with project management experience.
- Expertise in Temperature Controlled/Cold Chain Logistics, Transportation, and Packaging.
- US Domestic and International experience required.
- Strong technical writing skills and strong Microsoft word knowledge.
- Ability to present to cross-functional teams and provide succinct clear updates and information.
- Experience working in a GMP environment is required.
- Experience in Failure mode analysis (Ishikawa, 5 why, or other).
Preferred Skills:
- Lean Six Sigma/Green Belt certification is an asset.
- Experience with MS Project and PowerPoint.
Ability to develop rapport at various organizational levels.
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Job Level: Management
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
