Specialist* Operational Investigational Product Logistics

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Become a member of the BioNTech Family!

BioNTech is a Germany-based biotechnology company with U.S. offices in Cambridge, MA and Gaithersburg, MD, that focuses on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19. The company's oncology pipeline contains several classes of drugs, including mRNA-based drugs to encode antigens, neoantigens, cytokines, and antibodies; cell therapies; bispecific antibodies; and small-molecule immunomodulators. BioNTech is partnered with several large pharmaceutical companies, including Roche, Eli Lilly, Pfizer, Sanofi, and Genmab. Comirnaty (COVID-19 vaccine) is its first commercialized product.

Specialist* Operational Investigational Product Logistics

Responsibilities
  • Demonstration and promotion of the company vision.
  • Adherence to the regulatory requirements and the respective procedures (policies, SOPs, instructions).
  • Operational support and independent performance of operational tasks as process expert in particular clinical trial supply activities related to storage and distribution/logistics e.g. organizing shipments including documents for customs, trouble shooting, checking invoices, TE handling and cumulative tracking.
  • Manage a variety of logistics issues e.g. excursions or deviations that may occur during shipment handling and storage of clinical trial material.
  • Responsible for project-related/project-independent GxP documentation and filing thereof, maintenance of lists.
  • Coordinate logistics of all drug-related storage and distribution activities in global Phase I-IV clinical trials. This includes deviation, change and CAPA management.
  • Support maintaining strategic alliances with contract partners for transportation, brokerage, storage, and distribution e.g. issue solving and alignment on timelines and processes.
  • Support working with CMO and CROs, manage the distribution and global depot locations with special considerations on Import Licenses and shipping lead times for country specific requirements.
  • Support the preparation and review of global trade related shipping paperwork such as FDA End Use Letters, Customs Invoices, USDA Statements, TCSA Statements, and Permits.
  • Support the set-up of Transport Instructions for allocated trials/R&D Programs/products/vendors to ensure the conduction of transport of clinical trial material in accordance with material and GDP requirements to prevent any impairment of product quality and thus any risk to patient safety.
  • Support of preparation of related documents (SOPs, Templates, etc.) to ensure GDP compliance and continuous state of inspection readiness in allocated clinical trials and within clinical trial supply department.

What you have to offer.

Qualifications
  • Supply Chain Management, Natural sciences, or technical background (university degree or successfully completed apprenticeship with experience in a GxP (GMP, GCP, GDP) related profession or similar
Experience
  • Quality management experience
  • Knowledge in relevant legislation and international GxP guidelines  with a focus on GDP
  • Experience in the GxP regulated area
  • Experiences in cold chain logistics, handling of temperature deviations preferable
  • Effective stakeholder management, both in cross-functional internal and external matrix team environment

Benefits for you.

  • Medical, Dental, and Vision Insurance
  • Life, AD&D, STD, and LTD Insurance
  • HRA & FSA Spending Accounts
  • Health & Wellness, including free onsite gym access
  • Adoption & Surrogacy Assistance
  • Vacation and Unlimited Sick Time
  • Holidays and Floating Holidays, including discretionary winter shutdown
  • 401(K) Plan with Significant Company Match
  • Tuition Reimbursement and Professional Development
  • Commuting Assistance and onsite parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
  • And more!

Have we kindled your pioneering spirit?

Then apply now for our location Cambridge, Massachusetts and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 4880 #LI-DCA (please indicate for inquiries)

We look forward to your application!

*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

https://biontech.de