Manager/Sr. Manager, Logistics Operations

2 months ago

Cambridge, Massachusetts, United States Cullinan Oncology Full time

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.

Position Responsibilities:

  • 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.

Candidate Requirements:

  • 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.

Preferred Qualifications/Experience:

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.

  • Senior Manager, SAS Operations

    3 weeks ago

    Cambridge, Massachusetts, United States Pfizer Full time

    ROLE SUMMARYThe Sr. Manager, Specialty Access Solutions, Operations & Execution is responsible for providing operations support to monitor the development, implementation, and execution of Specialty Pharmacy (SP) processes throughout the Specialty Access Solutions COE. This will include analyzing and monitoring key elements of SPP Contract implementation...

  • Sr. Clinical Trial Manager, Clinical Operations, Oncology

    7 days ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The RoleThe Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs. The position may report to the Sr. Director,...

  • Sr. Manager, Communications

    2 months ago

    Cambridge, Massachusetts, United States Biogen Idec Full time

    Job Description The Sr. Manager, BI&O Communications and Change Management role is responsible for leading the narrative for the BI&O organization's purpose, progress and impact on performance, innovation, and transformation. This role will need a strategic mindset to grasp and craft the right level of topics and discussion around Insights & Analytics, Data...

  • Sr Program Manager, Services Development

    3 weeks ago

    Cambridge, Massachusetts, United States Philips Full time

    Job TitleSr Program Manager, Services DevelopmentJob DescriptionSr Program Manager, Services DevelopmentAs one of our Senior Program Managers, you will be taking on End-to-End ownership of complex and high impact service development programs within the Business Innovation & Service Delivery team in the Hospital Patient Monitoring business unit.Your role:...

  • Sr Clinical Marketing Manager, Sleep

    2 weeks ago

    Cambridge, Massachusetts, United States Philips Full time

    Job TitleSr Clinical Marketing Manager, SleepJob DescriptionSr Clinical Marketing Manager, Sleep As our Senior Clinical Marketing Manager for Sleep, you will be joining the highly impactful Therapy Platforms business within Sleep & Respiratory Care team at Philips. You will be part of a truly global work environment that is committed to improving billions of...

  • national sales manager/freight forwarding

    2 months ago

    Cambridge, Massachusetts, United States gpac Full time

    NATIONAL SALES MANAGER/FREIGHT FORWARDINGThe National Sales Manager will be responsible for leading the sales team and developing sales strategies to increase revenue and market share in the Shipping and Logistics Freight Forwarding industry. This role requires a deep understanding of the freight forwarding market and experience in managing sales teams.Key...

  • Farm Equipment Operator

    1 week ago

    Cambridge, Massachusetts, United States A & W Farm Operations Full time

    Welcome to A&W Farm Operations We're hiring a Farm Equipment Operator to join our team in Cambridge, IA (about 20 miles southeast of Ames). In this role you will be operating and performing maintenance on various types of farm equipment including tractors, planters, sprayers, combines, etc. We are a leading player in the agriculture sector, specializing in a...

  • Sr. Manager, Clinical Biomarkers, Oncology

    4 weeks ago

    Cambridge, Massachusetts, United States ModernaTX, Inc. Full time

    The Role:Moderna is seeking a Sr. Manager, Clinical Biomarkers to develop and drive biomarker plans across clinical stage Oncology programs. This position reports to Moderna's Associate Director of Oncology, Clinical Biomarkers. The Senior Manager will work collaboratively across biomarker and translational teams (internal, external CROs) to ensure planning,...

  • Sr. Director, Global HR Operations

    3 months ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    As the Sr. Director of HR Operations at Moderna, you will be responsible for leading our global HR operations, encompassing HR service delivery, process documentation and execution, knowledge management, audit and compliance, vendor management, and data and reporting. This role demands the design and implementation of an advanced HR operations strategy to...

  • Sr. Manager, Clinical Safety Scientist

    3 months ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The Role:Join Moderna Therapeutics enthusiastic and collaborative team and make a significant impact on the overall success novel messenger RNA approach to drug development. By joining our Clinical Safety Science Team, the Sr. Manager is responsible for performing core pharmacovigilance activities in partnership with the Global Medical Lead by supporting the...

  • Sr. Manager, Tax

    2 weeks ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The Role:Moderna is on the lookout for a Senior Manager, Tax to become an integral part of our Tax team. This role offers a unique opportunity to contribute significantly to Modernas growing global finance organization, supporting our mission to revolutionize the biotech industry with rapid growth. Positioned in our LEED-certified headquarters in Cambridge,...

  • Operations Manager, Custodial Services

    4 weeks ago

    Cambridge, Massachusetts, United States Motion Recruitment Full time

    Our client, a well known Ivy League University is urgently hiring for a Operations Manager, Custodial Services to join their team. This role is onsite in Cambridge, MA so local candidates only apply. ***This is a 3 month initial contract with potential for long-term extension or conversion based on performance*** In this role, you will oversee all day,...

  • Operations Manager AIML

    2 weeks ago

    Cambridge, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: London The Stanley Building, Cambridge 300 Technology SquarePosted Date: Aug The Operations Manager is a key role in operations with a purpose to work with the artificial intelligence-machine learning (AIML) group to support in driving forward key projects and initiatives. The AIML group is working in an exciting and exploratory space focusing on...

  • Manager, Vivarium Operations Actions

    4 weeks ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The Role:We are seeking a highly motivated and talented vivarium operations manager for the In Vivo Pharmacology group to engage with teams at Moderna. This hands-on management role is essential for leading a team tasked to support platform science to deliver on the promise of mRNA-based medicines. We are looking for an individual passionate about animal...

  • Product Manager

    3 weeks ago

    Cambridge, Massachusetts, United States InterSystems Full time

    InterSystems HealthShare seeks strong product leaders to help create the next generation of solutions to highly important health and healthcare issues.InterSystems HealthShare is the premier health interoperability and innovation platform, providing unique solutions for today's widely distributed healthcare in which a single patient may connect to many...

  • Sr Manager, TMF Quality Oversight

    1 week ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Clinical Trial Systems Operations (CTSO) team within Clinical Trial Excellence and Support at Moderna is looking for an agile, self-motivated, and experienced team leader to work across clinical trials to conduct quality reviews of trial master files (TMF) and related documentation to help ensure TMFs meet regulatory standards and meet Modernas...

  • Sr Manager, Sales Development

    4 days ago

    Cambridge, Massachusetts, United States Solo Full time

    Who we are.Solo enables companies to Connect, Secure and Observe modern applications – APIs, Microservices and Data – with the industry's leading API and Service Mesh Management Platform ("Gloo"). Solo innovations allow companies to stay on the leading edge of both technology and business possibilities.Solo is a VC-backed company, founded in 2017 by Idit...

  • Submissions Manager, Regulatory Operations

    5 days ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Regulatory Operations Submission Manager is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The...

  • Quality Development Manager

    4 weeks ago

    Cambridge, Massachusetts, United States InterSystems Full time

    As a Quality Development Manager, you will contribute to developing high quality, robust InterSystems HealthShare software by working hard to uncover weaknesses and areas for improvement. If you are passionate about software you will excel in this role by building tools and automation that verify new technologies and new healthcare-related protocols. We will...

  • Sr. Manager, PV Reporting, Digital Innovation

    3 months ago

    Cambridge, Massachusetts, United States Moderna, Inc. Full time

    The Role:Reporting to the Head of Digital Innovation in the Pharmacovigilance Operations group, this individual experienced in the Pharmacovigilance (PV) reporting landscape will design, manage, and lead the data output from our state-of-the-art Signal Management, Analytics and Reporting Tool. This will require ensuring the data output is aligned with the...