About This Role  

The Global Logistics & Distribution Senior Engineer role is a member of the Global Distribution & Cold Chain Solutions team within Global Logistics.  In this role, the Senior Engineer is a key subject matter expert on distribution packing, cold chain solutions, and shipping qualification.  Will ensure deployment and continual improvement of essential programs of the supply chain such as Cold Chain and Shipping Validation, as well as support to Technical Transfers, Commercial Launches, and Clinical Programs.  Will have the responsibility for shipping solutions to meet end-to-end supply chain distribution/logistics needs globally, including all product phases from raw materials and critical components through finished goods, that ship globally from any Biogen plant, contract manufacturing organization, 3PL or partner.  Ensure all clinical and commercial programs are compliant with Biogen’s internal requirements in additional to any cold chain/transport qualification best practices, guidance, and regulations.

What You’ll Do  

• Support regulatory submissions, audits/health authority inspections, and regulatory agency questions related to transport qualification for distribution and cold chain solutions.
• Responsible for overseeing/coordinating and performing testing transportation qualification testing including supply chain lane qualifications for new product launches, program life cycle management, new innovations for shipping systems, sustainability & continuous improvement initiatives.
• Lead and/or assist in the design, development, testing, and support of clinical, commercial, and cold-chain distribution packaging
• Act as Technical Transfer lead for Distribution and Cold Chain operations at internal sites, CMO, and 3PL sites.
• Act as global point of contact for internal stakeholders and external customers, in case of cold chain and shipping validation requests.
• Support and create communications to ensure that internal stakeholders and are fully informed and knowledgeable of Cold Chain and Shipping Validation program activities and their status.
• Supports the selection of new vendors and actively participates in Supplier Relationship Management meetings and QBRs; actively participates in RFPs and has knowledge of total landed cost calculations/budget impact
• Contributes to standards for use by affiliates to address external temperature excursions
• Provide input and provide support for temperature monitoring strategy; stability plans; launch plans
• Manage any Trackwise related events, CAPAs, investigations under supervision.

Who You Are  

• This individual is able to display technical insight in the design and execution of processes and procedures. 
• Able to deal with high level of ambiguity and complexity, anticipates potential risks, develops corresponding contingency plans, and is capable of acting proactively in order to support strategic and complex decisions.  
• Applies in‐depth understanding and thorough knowledge of the area of work and related disciplines.
• Must be able to work independently to generate scientifically valid data and carry out routine analyses.

Required Skills  

• BS Degree + 3-5 years packaging, global logistics or temperature controlled supply chain experience
• Experience within an international and regulated environment is required
• US Domestic and International experience required
• Strong analytical, problem solving and communication skills (excellent written and verbal communicator with the ability to articulate recommendations and key decision points to senior management)
• Demonstrated experience reducing complex subjects to key points.
• Ability to work in fast paced environments and great organizational skills to effectively balance a broad range of projects and tasks in parallel
• Exceptional team player (ability to direct and participate in cross functional and management teams). Ability to develop a strong network across the company.
• Excellent project management experience and ability to work in cross-functional teams.
• Experience in MS Project and Powerpoint
• Expertise and operational understanding of Temperature Controlled/Cold Chain Logistics, Transportation, Packaging
• Ability to develop rapport at many levels in the organization
• Mid level of understanding and application of guidance’s that regulate temperature controlled supply chain logistics including but not limited to cGMP, cGDP, 21 CFR Part 11, NVISA, Health Canada, etc.

Preferred Skills 

• BS/BA in Packaging Science/Engineering
• Lean Six Sigma/Green Belt is an asset
• Working knowledge of packaging related standards and regulations.

Why Biogen?  

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.