Logistics Engineer, Cold Chain Packaging & Shipping Qualification (Research Triangle Park, NC)

This job is with Biogen, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

About This Role:  

As a Logistics Engineer, you will be a pivotal member of the Global Distribution Packaging & Shipping Qualification team. This role is essential in ensuring that Biogen's distribution packaging and cold chain solutions are optimally selected, qualified, and implemented to meet the temperature-controlled supply chain needs.

You will lead and support the design, development, testing, and support of clinical, commercial, and cold-chain distribution packaging. Your contributions will be vital to the end-to-end supply chain logistics, encompassing all product phases from raw materials to finished goods across global sites. You will work independently to generate scientifically valid data and perform routine analyses, ensuring all work complies with cGMP requirements, SOPs, and test methods. This role involves collaboration with various departments, including Logistics, Quality, and External Manufacturing, to address business needs and support audits and regulatory inquiries. Your influence and negotiation skills will be key in navigating complex decisions and driving strategic initiatives.

What You'll Do:

• Lead improvement projects focused on distribution to enhance capabilities and implement new technology.

• Design, develop, and test complex distribution packaging projects from conceptual design through implementation

• Manage external vendors and contribute to the development of distribution packaging standards.

• Draft strategies, operational protocols, and supply chain study reports for clinical and commercial programs.

• Develop test strategy for GMP products that will cover global regulatory requirements

• Participate and facilitate Supplier Relationship Management meetings and RFPs, managing vendor relationships.

• 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 shipping qualification 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

• Lead weekly cross-functional shipping qualification sub teams and participate in operational/business review meetings.

• Develop and maintain relationships with key customers and partners across various departments such as Logistics, Quality, and other departments to proactively address business needs.

• Coach and provide guidance to team members, including contractors

Who You Are:

You are a detail-oriented engineer with a strong analytical mindset and exceptional problem-solving skills. You are an organized and compliance driven thinker. You thrive in fast-paced environments and have excellent organizational abilities to manage multiple projects simultaneously. You possess strong communication skills, enabling you to articulate complex recommendations to senior management effectively. As a team player, you excel in cross-functional collaborations and can build robust networks across the company. Your expertise in temperature-controlled logistics, cold chain solutions, and packaging makes you a valuable asset in driving innovative solutions.

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 (cGMP, cGDP, 21 CFR Part 11, ANVISA, Health Canada) with knowledge of packaging standards (ASTM/ISTA) and regulations.

• Expertise in Temperature Controlled/Cold Chain Logistics, Transportation, and Packaging.

• Experience in testing standards and distribution lab environment

• US Domestic and International experience required.

• Strong technical writing skills and strong microsoft word knowledge. Proficiency in MS Project and PowerPoint.

• Ability to present to cross-functional teams and provide succinct clear updates and information

• Ability to develop rapport at various organizational levels.

• Experience working in a GMP environment is preferred. 

• Strong analytical, problem-solving, and communication skills.

• Exceptional team player with project management experience.

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.

 

Job Level: Management

Additional Information

The base compensation range for this role is: $103,000.00-$137,500.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. 

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement 
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance 
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit 
• 401(k) program participation with company matched contributions
• Employee stock purchase plan 
• Tuition reimbursement of up to $10,000 per calendar year 
• Employee Resource Groups participation

Why Biogen?

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 our 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.