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Senior Manager, Logistics

Cellares

Cellares

Operations
Bridgewater, NJ, USA
Posted on Friday, April 12, 2024
Position Summary
We are seeking a highly motivated Senior Manager, Logistics who will manage clinical and commercial vein to vein logistics activities, focusing on autologous and allogeneic client programs at Cellares. The primary focus is on managing incoming patient apheresis and outgoing final drug product, import/export requirements and collaborating with third-party logistics companies. This position involves serving as the main point of contact for partners, ensuring on time, compliant, day-to-day shipment management, monitoring vendor performance through KPIs, and tracking budgets. In this highly visible role, the successful candidate will join the existing supply chain team team to coordinate activities across our manufacturing sites, labelling and distribution, and other key stakeholders to deliver our clients’ products. The position requires enthusiasm, passion, and attention to detail. The Sr. Manager will be responsible for all processes associated with delivery, receipt, and storage of patient apheresis and distribution of clinical and commercial cell therapy drug products that will be manufactured within a state-of-the-art multi-product cell therapy manufacturing facility.
This individual will play a critical role in the logistics processes ensuring appropriate controls, complete traceability, and efficient operations to support the production of cell therapy products through safe and compliant manufacturing operations according to cGMP requirements. This individual will lead different operations within the logistics space while providing strategic and operational efficiencies, cost savings, shipping accuracy and leadership actions. This position assures individual compliance with all FDA and regulatory agencies and applicable policies, regulations and certifications including training, documentation, standard operating procedures, and corporate policies. The Senior Manager will maintain a compliant, effective, safe and efficient operation that meets or exceeds site goals and objectives.
This is a multidisciplinary role & this individual will need the ability to interface with all levels of the organization, including Manufacturing, MS&T, Quality Assurance, QC, Process/Analytical Development, Supply Chain, Training, Engineering/Facilities, HS&E, and Finance.
The successful candidate should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.

Responsibilities

  • Lead day to day support of clinical and/or commercial supply operations for autologous and allogeneic cell therapies, including scheduling, tracking, and managing clinical product logistics and performing quality checks across the supply chain to ensure compliance
  • Act as a first line resource to manage the interface between functions pertaining to supply, transportation, logistics, and traceability issues for clinical and commercial products
  • Generate and maintain a clinical and/or commercial supply plan to drive manufacturing, labeling, and forecasting logistic supply activities across internal and external stakeholders
  • Coordinate with manufacturing sites, client sites, and 3rd party storage/distribution vendors and other internal stakeholders to ensure on time shipment and delivery of drug product
  • Work closely with Clinical and Commercial Operations, Manufacturing, Quality, along with other service providers to ensure seamless operation of clinical trials and commercial supply and address any challenges
  • Review upcoming inbound patient material and outbound drug product to ensure alignment with internal and external stakeholders
  • Participate in the Sales and Operations Planning process, attend weekly and daily huddles to ensure alignment with all functions of the supply chain, manufacturing, quality, and warehouse operations
  • Participate/lead investigations into exceptions in labeling, storage, and logistics activities in close collaboration with Quality
  • Identify issues and/or risks within logistics in meeting clinical and/or commercial supply requirements and suggest solutions to meet timelines
  • Responsible for chain of identity and chain of custody between clinical and/or commercial and manufacturing sites
  • Develop and maintain materials for Cellares sites to ensure effective product handling (e.g., manuals, visual work instructions, information sheets, checklists, and other documents)
  • Consistently perform duties within established SOPs, and in accordance with GXP requirements
  • Provide support to the Senior Director of Supply Chain with ad-hoc tasks as required

Requirements

  • Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields
  • A minimum of 8 years of experience within a cGMP environment in the biotech/biopharma industry concentrated within Logistics, Manufacturing, and Supply Chain
  • A minimum of 5 years leadership experience
  • Cell/Gene Therapy or CDMO experience is required
  • Experience with 3PL Logistics and Warehousing is required
  • Understanding of cryopreservation and shipping/handling of cryopreserved patient material/Apheresis is required
  • Proficiency in Chain of Identity (CoI) and Chain of Custody (CoC) E2E management
  • Proficiency in ERP systems/WMS Applications and analytics tools in a plus
  • Advanced knowledge of cGMP/GDP/Pharmaceutical regulations
  • Advanced knowledge of Quality and Compliance systems
  • Advanced knowledge of OSHA, DEA, USP and other applicable regulations
  • Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members
  • Excellent organizational and communication skills
  • Self-motivated and passionate about advancing the field of cell therapy
  • Self-awareness, integrity, authenticity, and a growth mindset
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.