Jesse Mosqueda Email & Phone Number

Medford, Ma, Us

Somerville, Massachusetts, Us

• Enrolling qualified treatment center’s patient and execute processes end to end (Enrollment to infusion).• Coordinating apheresis and final drug product to and from the QTC to CMO.• Provide white glove services to QTC in a specific region.• Create, manage, and enhance SOP and WI within timelines.• Working alongside bluebird cross functional teams, manufacturing partners, and distribution partners to ensure “right first time” execution.• Attending cross-functional commercial project meetings and represent the patient supply team.• Effectively communicating any risks and mitigation plans associated with commercial projects.• Providing support to clinical meetings and working with manufacturing team in supporting cGMP production runs at CMO.

Lawrence Township, Nj, Us

• Operationalized FDA approved commercial GMP Cell Therapy facility. • Test and operationalize ERP (SAP S4) system to create GMP processes for warehouse and material operations. • Hire, build, manage, and train employees joining new department by creating an environment to foster a culture of safety, effective communication, sense of urgency, accountability, high motivation, and goal achievement. • Drive cross-functional collaborations within site and across the network to problem solve • Apply new systems to integrate into GMP warehouse processes. • Manage all processes related to incoming GMP material receipt including inspection, documentation, and system updates. • Track and analyze KPIs for Warehouse and Receiving department. • Develop, cross train, and motivate technicians with a focus on regulatory inspection readiness.

Houston, Tx, Us

• Supervise and perform all processes related to incoming GMP material receipt including inspection, documentation, and system updates.• Order, manage, and forecast inventory levels based on the influx of manufacturing operations on various product pipelines.• Oversee and recommend the layout and set up of the warehouse for appropriate ambient and cold chain storage in a cGMP environment.• Create, organize, and supervise inventory management controls and processes such as cycle counts, inventory dispensing, kitting activities, and final product shipment.• Adapts Supply Chain Logistics solutions to changing conditions, improving processes and services.• Create and follow work instructions and Standard Operating Procedures with regards to warehouse operations.• Establish departmental goals and objectives that improves GMP materials performance for the organization.• Track and analyze KPIs for Supply Chain department.• Establish a Chain of Custody system from raw material through the production of final product.• Develop, cross train, and motivate technicians with a focus on regulatory inspection readiness.• Coordinate staffing plans and recommendations based upon workload and support requirements.• Analyze reports, measurements and external benchmarks to identify opportunities for continuous improvement.• Adhere to corporate governance of Regulatory Compliance processes related to material operations.

Houston, Texas, Us

• Manage and forecast inventory levels based on the influx of manufacturing operations on various product pipelines.• Create, organize, and supervise inventory management controls and processes such as cycle counts, inventory dispensing, kitting activities, and final product.• Establish a Chain of Custody system from raw material through the production of final product.• Implement risk mitigation plans for high risk materials.• Track and analyze KPIs for Materials Management department.• Develop, cross train, and motivate technicians with a focus on inspection readiness.• Supervise and perform shipping and receiving of raw material, final product, lab equipment, and temperature sensitive materials nationally and internationally.• Streamlined kitting processes within regulatory guidelines without impacting quality.• Streamlined receiving process by implementing a new labeling system for raw materials.

Houston, Texas, Us

• Plan, organize, and lead materials management activities to support a clinical stage startup cell gene therapy company.• Collaborate with quality, manufacturing, and research departments to facilitate materials flow within the organization.• Generate and present reports for change controls, deviations, CAPAs, and SCARs.• Lead shipping and receiving of raw material, final product, lab equipment, and temperature sensitive materials nationally and internationally.• Inspect and receive GMP and non-GMP material upon delivery.• Create, edit, and implement standard operating procedures to stream line materials management operations.• Cross trained Materials Technicians across all departmental procedures. • Ensure warehouse/storeroom is in good working order by maintaining areas to 5s standards.• Created KPI for cycle count accuracy, on-time kitting accuracy, and deviation frequency.

Santa Monica, California, Us

• Managed the packaging and shipping of final product and mitigate issues that may arise during packaging with QA.• Led GMP inventory counts to ensure accurate inventory levels and proper segregation of materials.• Create and edit SOPs so that they are clear for operators performing tasks.• Manage shipping and receiving for Non-GMP material and equipment for R&D department.• Develop 5s system to maintain GMP warehouse in good working order for audits.• Lead internal and external audit inspections with Quality groups in preparation of FDA audits.• Scheduled meetings with Internal customers and vendors to resolve major issues experienced with vendors.• Receive and perform primary inspection of GMP material/equipment and Non-GMP material/equipment.• Initiate and complete deviation reports, SCARs, CAPAs, and change controls.• Collaborate with quality departments to inspect, release, or dispose of any GMP materials.• Streamline the processes of collecting, kitting, staging, and establishing chain of custody for GMP material.• Lead shipping and receiving of raw material, final product, lab equipment, and temperature sensitive materials nationally and internationally.