Description
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients.
We have strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both oncology and autoimmune disease. Our portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class.
Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of cancer and autoimmune indications.
We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization.
With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients.
Summary:
Cullinan Therapeutics is seeking an experienced Manager/Sr. Manager reporting to the Director, Distribution and Logistics, you will support the planning, creation, implementation, build, and optimization of shipping logistics operations to ensure uninterrupted and timely clinical drug supply for Cullinan’s clinical programs, as well as distribution and logistics support for the RND, CMC, and Clinical teams as needed.
\n- Monitor and arrange day to day domestic and international shipments for the CMC and RND teams using Cullinan tools and processes, minimizing any requirement for Cullinan team involvement outside of the Cullinan Supply Chain team:
- Follow pre-existing shipment design plans for repeat shipment lanes.
- Help construct shipment design plans for new lanes.
- Produce necessary shipment documentation as applicable, considering all Trade Compliance data elements associated as needed (including but not limited to, Exporter of Record, Importer of Record, commodity descriptions for Customs purposes, material quantities, HTS codes, Value for Customs, Country of Origin, Incoterms, Intended Use, Transport Hazard statements, shipping and storage temperatures, permit/license/declaration details).
- Ensure Cold Chain packaging is adequate for the material being shipped and the shipment lane (using Cullinan tools and processes).
- Ensure detailed in-transit shipment monitoring at critical points in transit for all shipments, ensuring timely involvement to expedite processes when needed.
- Ensure the fast recovery and analysis of Temperature Monitor data as applicable.
- Ensure all relevant stakeholders are updated of shipment activities door to door.
- Help ensure the uninterrupted delivery of materials domestically and internationally, helping with issue resolution.
- Provide monitoring support for Clinical Logistics sample shipments as needed.
- Accurately manage and report on inventory levels associated with Cullinan materials at third-party facilities world-wide.
- Help develop the inventory management system.
- Maintain accurate documentation within Cullinan systems.
- Help identify areas for process improvement initiatives and participate in metrics review discussions.
- Participate in Cold Chain packaging reviews and any associated improvements.
- Help maintain and grow relationships with logistics related vendors.
- Participate in Freight Forwarder, Import Broker, and Storage vendor Business Reviews as applicable.
- Help manage the logistics and inventory budget.
- Escalate issues to the Cullinan Distribution and Logistics head.
- Provide support to the broader Cullinan Supply Chain team as needed.
- 7 years’ of progressive experience in Global Trade Operations and Compliance within the Biotech/Pharma industry.
- Experience with dealing with Import/export/Interstate permits/licenses and associated regulatory agencies (US at a minimum – US Customs, FDA, USDA, USFWS, CDC, EPA, DEA, etc.). Experience with similar agencies in Europe and Asia is preferred.
- Ability to operate effectively and consistently in a fast-paced environment.
- Strong cross-functional communication skills.
- High level of organizational skills.
- Ability to operate in a hybrid/remote environment with a self-motivated personality.
- Ability to remain unphased by shifting priorities and changing shipment requirements.
- A problem-solving attitude.
- Experience in successfully shipping a wide variety of biological and chemical materials within the Biotech/Pharma industry, at a range of different temperatures.
- Proficient knowledge of Microsoft Excel.
- General Knowledge of GxP.
- BSc/BA in a scientific discipline/engineering/Supply Chain.
- Experience in working at a specialist Freight Forwarder, CRO/CMO/CDMO and Biotech/Pharma preferred.
- Scientific background.
- Detailed knowledge of specialist Freight Forwarder and integrator global operations.
- APICS certifications (e.g. CLTD / CSCP).
- IATA Dangerous Goods training.
- Multi-country workplace experience.
- Lean six sigma experience.
- Ability to travel to the Cullinan Therapeutics facility in Cambridge MA at least once a week.
Cullinan Therapeutics is proud to be an Equal Opportunity Employer. We are committed to creating an inclusive and diverse environment for all employees and applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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