Full-Time

Senior Manager

Logistics

Posted on 4/12/2024

Cellares

Cellares

51-200 employees

Integrated platform for cell therapy manufacturing

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

Cellares offers the Cell Shuttle, an integrated platform for cell therapy manufacturing, utilizing Industry 4.0 technologies to enable true walk-away, end-to-end automation, modular hardware, purpose-built process design software, and scalable manufacturing from preclinical to commercial scale, resulting in reduced process failure rates and up to 70% cost reduction compared to manual processes. The company aims to accelerate access to life-saving cell therapies by deploying Cell Shuttles in Smart Factories globally, partnering with academia, biotechs, and pharma companies to lower manufacturing costs and meet global patient demand.

Company Stage

Series C

Total Funding

$373M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights
Headcount

6 month growth

15%

1 year growth

43%

2 year growth

96%
INACTIVE