Clinical Supply Chain Import-Export and Logistics Operations, Cell Therapy (Manager/Senior Manager)

Company: Takeda Pharmaceutical
Location: Boston
Posted on: January 27, 2023

Job Description:

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Job Description

About the role:
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Cell Therapy Clinical Supply Chain Import-Export and Logistics Operations (Manager/Senior Manager) where you will ensure Takeda import/export activities for Cell Therapy clinical programs are processed, according to policies and procedures, and in accordance with Customs and other applicable governmental agencies regulations. You will also ensure volume of shipments and programs are balanced among all import-export operational specialists, and import-export specialists are trained and ready to execute shipments. As part of the Cell Therapy, you will report to the Cell Therapy Supply Chain Program Lead.

How you will contribute:

• You are responsible for ensuring Takeda import/export activities for Cell Therapy clinical programs are properly and timely processed, according to policies and procedures, and in accordance with Customs and other applicable governmental agencies regulations.
• Ensure volume of shipments and programs are balanced among all import-export operational specialists, and import-export specialists are properly trained and ready to execute shipments.
• Manage relationship of Takeda and Supply Chain external partners, in particular, Third Party Logistics Providers (carrier, freight forwarder, customs brokers, warehouse & distribution providers), conducting quarterly business reviews, as well as maintaining providers within a satisfactory KPIs level.
• Manage Accounts Payable process in support to any related expenses, such as transportation, customs clearance and Participating Government Agencies-PGAs import and export permits.
• Manage daily logistics, distribution and import-export operational activities to ensure shipments of Cell Therapy products are processed timely and properly so clinical studies and project timelines are not affected, and supply chain pipeline is kept uninterrupted.
• Ensure compliance and adherence to country specific regulations and standard operating procedures for importing/exporting Cell Therapy clinical trial material and raw materials, including logistics, customs clearance and delivery cycle times. This includes US Customs and Border Protection(Customs), USDA, FDA, Fish Wildlife, CDC, Bureau of Industry and Security, DEA, FAA and possible other government agencies. This includes generating shipping documentation, working closely with the requester on specific to imports or exports.
• Maintain and manage all international product data for development compounds: Country of Origin, Harmonized Tariff Codes, Export Commerce Control Number (ECCN), PGA Licenses & Permits, FDA product codes, IND's for raw materials, chemical intermediates, and finished goods.
• Instruct customs brokers and freight forwarders on the clearance of Cell Therapy import/export transactions. Conduct post-entry review ensuring transactions comply with US import regulations
• Verify all international product data for CLINICAL AND RESEARCH AND DEVELOPMENT SUPPLIES: Country of Origin, Tariff Code/Schedule B, Export Commerce Control Number (ECCN), FDA product codes, NDA's, IND's for raw materials, chemical intermediates, and finished goods, are the ones determined and established by the Trade Compliance group.
• Where applicable, manage a team of distribution, logistics and import-export specialists (internal and/or external) ensuring specialists are well trained and prepared to support the pre-assigned clinical trial studies within the requirements of its transportation/logistics modalities, as well as support team members on their specific projects.
• Proactively work and influence internal and external stakeholders (including but not limited to Takeda Cell Therapy clinical program/product teams, in-country coordinators/ CROs/ CMOs/ CDMOs) to establish standard import and export requirements for clinical trials, including import/export solutions that adhere to international trade regulations and product quality.
• Manage network and relationships with Cell Therapy Supply Chain external partners, in particular 3rd party Logistics Service Providers, ensuring key performance indicators are maintained at a satisfactory level and such network encompasses all services required by Takeda business.
• Work closely with Global Trade Compliance team on formal inquiries from Global Customs and/or Trade authorities to ensure proper response is provided.
• Develop effective KPI measurable indicators for all aspects of global logistics, distribution and import-export operational activities such as volume, type of entries, duties and transportation costs, and other available metrics that can be built using ACE (Automated Customs Environment) and other systems.
• Develop, publish and implement control documents (policies, procedures, protocols, processes, and work instructions) for Import and Export Operational activities.
• Work closely with Global Trade Compliance group in the determination of key trade data such as Country of Origin, Tariff Code/Schedule B, Export Commerce Control Number (ECCN), FDA product codes, NDAs, INDs and customs valuations for products imported/exported to support Takeda projects.
• Responsible for the maintenance of key trade operational data in a centralized, automated import/export system.
• Identify key opportunities for process improvements and implement solutions to eliminate identified compliance deficiencies. Minimum Requirements/Qualifications:
  • Bachelor's Degree, preferred in Business, Science or Law
  • Minimum 4 years' experience in R&D material management/clinical supplies/logistics, including at least 2 years' experience in importing and exporting.
  • Experience in Pharmaceutical, Medical Device & Clinical Supplies highly preferred
  • Strong understanding and experience with international trade compliance laws and regulations including but not limited to, imports, exports, economic sanctions, Harmonization Tariff system (HTS), country of origin, boycott laws and Free Trade Agreements.
  • Working knowledge of trusted trader programs including Customs-Trade Partnership Against Terrorism (C-TPAT) and Importer Self-Assessment (ISA) Preferred:
    • Valid Customs Broker License and other certifications, when regionally possible.
    • MBA or Masters
    • Import/Export auditing experience
    • HAZMAT Certification IATA and IMDG
    • Proficiency in computer software Excel and MS Project or equivalent project management software is a plus
    • Ability to influence stakeholders from many technical disciplines and at many levels.
    • Ability to apply multiple lenses to analyze and represent complex interdependencies, scenarios, and tradeoffs. What Takeda can offer you:
      • Comprehensive Healthcare: Medical, Dental, and Vision
      • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
      • Health & Wellness programs including onsite flu shots and health screenings
      • Generous time off for vacation and the option to purchase additional vacation days
      • Community Outreach Programs and company match of charitable contributions
      • Family Planning Support
      • Flexible Work Paths
      • Tuition reimbursement More about us:
        At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
        
        Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
        
        This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
        
        Base Salary Range: $102,200.00 to $146,000.00, based on candidate professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
        
        The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
        
        EEO Statement
        
        Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status . click apply for full job details

Keywords: Takeda Pharmaceutical, Boston , Clinical Supply Chain Import-Export and Logistics Operations, Cell Therapy (Manager/Senior Manager), Executive , Boston, Massachusetts