Full-Time

Senior Manager

Logistics

Updated on 5/17/2024

Cellares

51-200 employees

Automated cell therapy manufacturing platform

Data & Analytics

Hardware

Senior

Bridgewater Township, NJ, USA

Required Skills

Data Analysis

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

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

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.

Cellares

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Website

View Company Profile

Cellares specializes in advanced cell therapy manufacturing with its proprietary Cell Shuttle platform. This platform exemplifies industry leadership by integrating state-of-the-art automation and software solutions, significantly reducing process failure rates and costs. Working at this company provides the unique opportunity to contribute to life-saving innovations while being part of a culturally rich environment that collaborates with top-tier academic and industry partners worldwide.

Company Stage

Series C

Total Funding

$373M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights

Headcount

6 month growth

↑ 19%

1 year growth

↑ 46%

2 year growth

↑ 95%