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.
