Manager Warehouse, Operations

We are seeking a highly motivated Manager of Warehouse Operations to lead a high-performing team responsible for all processes associated with material receipts, movement, storage, and distribution of RUO and GMP material.

This individual will play a critical role in the warehousing processes, ensuring appropriate controls, complete traceability, and efficient operations. These operations may include general warehousing, material kitting, cold chain operations, and dispensary activities.

This position ensures individual compliance with all FDA and regulatory agencies and applicable policies, regulations, and certifications, including training, documentation, standard operating procedures, and corporate policies. The right candidate will maintain a safe, compliant, effective, and efficient operation that meets or exceeds site goals and objectives.

This is a multidisciplinary role, and the individual will need to interface with all levels of the organization, including Manufacturing, MSAT, Quality Operations, Quality Control, Process/Analytical Development, Supply Chain, Engineering/Facilities, EH&S, 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

• Develop scalable systems and processes for incoming material receipt, storage, movement, and distribution
• Establish standard operating procedures (SOPs) and training programs for the Supply Chain team and all departments interfacing with the Warehouse
• Hire, mentor, and develop an effective Warehouse team, focusing on safety, quality, delivery, and compliance
• Operate within the requirements of a validated warehouse system, manage daily operational activities associated with receiving GMP material, material movement, kitting, outbound logistics (domestic and international)
• Establish systems and processes for cost-effective and dependable domestic and international shipping operations, at various temperature ranges
• Develop an inter- and intra-department communication framework; establish and run daily huddles and weekly staff meetings as needed to drive excellence and monitor performance
• Establish a warehousing labor capacity model for supply review as part of the Sales and Operations Planning Cycle
• Champion and enforce safety guidelines; promote a safe workplace, ensure compliance of warehouse staff certifications (ex, forklift cert, etc)
• Perform physical inventory checks at site-mandated cadence (monthly or quarterly), ensure 99 % inventory accuracy, and provide inventory reports
• Define, monitor, and improve Warehouse Key Performance Indicators associated with Safety, Quality, and Delivery
• Support implementation and/or integration of ERP system(s) and ensure compliance upon launch
• Maintain shipping, receiving, staging, kitting, and storage areas that are compliant, efficient, effective, and safe
• Engage with various groups to manage and expedite receipt, along with ensuring appropriate sampling/inspection of incoming materials
• Manage the creation, implementation, and compliance for all Warehouse documentation, procedures, and policies, including materials management, cycle counting, etc
• Identify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resources
• Build and maintain systems to continuously monitor, analyze, and optimize Warehouse Operations and support and own Warehouse Quality events, including change controls, investigations, and CAPAs
• Lead and actively participate in all regulatory and internal audits of the facility
• Work closely with other functional areas to develop and execute against the strategic plan for the manufacturing site
• Build Operational Excellence capabilities through training, continuous improvement tools, and events such as 5S assessment and Kaizen within the Warehouse
  
  

Requirements

• Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management, or related fields
• 5 years of experience within a cGMP environment in the biotech/biopharma industry, concentrated within Warehouse Operations, Manufacturing, and Supply Chain
• 2 years of leadership experience,
• Process-oriented with an advanced understanding of material and product flow, methodical thinker
• Cell/Gene Therapy experience preferred
• Advanced knowledge of warehouse operations, including best industry practices, application of principles, concepts, practices, standards, validation, and qualification
• Advanced knowledge and understanding of cGMP/GDP/Pharmaceutical regulations
• Advanced knowledge of Quality and Compliance systems, with an understanding of ISO 9001 and 13485
• Advanced knowledge of OSHA, DEA, USP, and other applicable WH regulations
• Advanced proficiency in ERP systems / WMS Applications, and analytics tools
• 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
• Strong analytical, problem-solving, and critical thinking skills, and the ability to lead as a change agent to promote flexibility, creativity, and accountability
• Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization
• Experience with Operational Excellence and/or Lean Manufacturing, Green belt or Black belt a plus
• Excellent organizational and communication skills
• Self-motivated and passionate about advancing the field of cell therapy
• Self-awareness, integrity, authenticity, and a growth mindset
  
  

$90,000 - $210,000 a year

Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent

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.