Clinical Supply Chain Import-Export and Logistics Operations, Cell Therapy (Manager/Senior Manager)
Company: Takeda Pharmaceutical
Posted on: January 27, 2023
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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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
- 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
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
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.
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 .
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Keywords: Takeda Pharmaceutical, Boston , Clinical Supply Chain Import-Export and Logistics Operations, Cell Therapy (Manager/Senior Manager), Executive , Boston, Massachusetts
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