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Cellares · 22 hours ago

Manager Warehouse, Operations

South San Francisco, CA

Full-time

Onsite

Mid, Senior Level

$90K/yr - $210K/yr

5+ years exp

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) focused on mass manufacturing cell therapies. The Manager of Warehouse Operations will lead a team responsible for material management processes, ensuring compliance with FDA regulations and operational excellence in a fast-paced environment.

BiotechnologyLife ScienceManufacturingMedicalTherapeutics

Growth Opportunities

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

Qualification

CGMP experienceWarehouse OperationsERP systems proficiencyQualityCompliance systemsAnalytical skillsProcess-orientedLeadership experienceTeamworkCommunication skillsProblem-solvingSelf-motivated

Required

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

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

Excellent organizational and communication skills

Self-motivated and passionate about advancing the field of cell therapy

Self-awareness, integrity, authenticity, and a growth mindset