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 distributionEstablish standard operating procedures (SOPs) and training programs for the Supply Chain team and all departments interfacing with the WarehouseHire, mentor, and develop an effective Warehouse team, focusing on safety, quality, delivery, and complianceOperate 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 rangesDevelop an inter- and intra-department communication framework; establish and run daily huddles and weekly staff meetings as needed to drive excellence and monitor performanceEstablish a warehousing labor capacity model for supply review as part of the Sales and Operations Planning CycleChampion 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 reportsDefine, monitor, and improve Warehouse Key Performance Indicators associated with Safety, Quality, and DeliverySupport implementation and/or integration of ERP system(s) and ensure compliance upon launchMaintain shipping, receiving, staging, kitting, and storage areas that are compliant, efficient, effective, and safeEngage with various groups to manage and expedite receipt, along with ensuring appropriate sampling/inspection of incoming materialsManage the creation, implementation, and compliance for all Warehouse documentation, procedures, and policies, including materials management, cycle counting, etcIdentify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resourcesBuild and maintain systems to continuously monitor, analyze, and optimize Warehouse Operations and support and own Warehouse Quality events, including change controls, investigations, and CAPAsLead and actively participate in all regulatory and internal audits of the facilityWork closely with other functional areas to develop and execute against the strategic plan for the manufacturing siteBuild 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 fields5+ years of experience within a cGMP environment in the biotech/biopharma industry, concentrated within Warehouse Operations, Manufacturing, and Supply Chain2+ years of leadership experience, Process-oriented with an advanced understanding of material and product flow, methodical thinker Cell/Gene Therapy experience preferredAdvanced knowledge of warehouse operations, including best industry practices, application of principles, concepts, practices, standards, validation, and qualificationAdvanced knowledge and understanding of cGMP/GDP/Pharmaceutical regulationsAdvanced knowledge of Quality and Compliance systems, with an understanding of ISO 9001 and 13485Advanced knowledge of OSHA, DEA, USP, and other applicable WH regulationsAdvanced proficiency in ERP systems / WMS Applications, and analytics toolsMust be able to manage shifting priorities to meet critical deadlines in a fast-paced and dynamic, growing environment, while providing clear direction to team membersStrong analytical, problem-solving, and critical thinking skills, and the ability to lead as a change agent to promote flexibility, creativity, and accountabilityExcellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organizationExperience with Operational Excellence and/or Lean Manufacturing, Green belt or Black belt a plusExcellent organizational and communication skillsSelf-motivated and passionate about advancing the field of cell therapySelf-awareness, integrity, authenticity, and a growth mindset Additional Information 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.
Compensation 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
