Manager, Validation

Benefits

Additional Information

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? - ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. - Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. - Work with a collaborative team with the ability to work across different areas of the company. - Ability to join a growing company with professional development opportunities. POSITION SUMMARY The Manager, Validation is responsible for being a hands-on leader to the validation staff as they perform qualification activities needed to meet company objectives. The role requires demonstrated ability to lead and align the validation team's efforts to meet dynamic and competing company priorities. This role must be proficient at developing validation protocols, executing protocols, creating summary reports, and managing validation activities in FDA regulated biopharmaceutical environments. ESSENTIAL FUNCTIONS Provide leadership and technical support for the validation group and work with Validation Associate Director to define, recommend, and justify validation budgets, capacity, personnel, and capital equipment needs, Plan, coordinate and track the progress of validation projects, Interface with management personnel in Engineering, Manufacturing, Regulatory Affairs, etc. Oversee and support commissioning, cleaning validation, process validation and equipment qualifications for new and existing equipment, utilities, and facilities, Interact and collaborate with cross-functional departments to define qualification requirements needed to meet company objectives, Establish project timelines and expectations, ensuring compliance to validate parameters Participating in implementation of Validation policies and procedures, Generate and execute validation protocols (IQ/OQ/PQ/PV/CV) for production equipment, laboratory equipment, utilities, facilities, and other related systems in an FDA regulated environment, as needed. Review and approve SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems, Lead validation scope planning meetings, as needed, to define qualification requirements for new and complex equipment, Maintain schedules for all GMP systems to ensure that they are requalified/revalidated on time, Oversee and Manage team and contractors to support multiple projects with shifting priorities, Train end-users on validation policies and requirements to support GMP operations, Perform risk assessments per QRM for GMP systems as required, Perform deviations, change controls, and CAPAs as required per QMS, Report on Validation Metrics to Quality Management Review, Utilize Six Sigma Lean ideology on Validation approaches, Mentor, coach, and train validation staff on validation practices, policies, and procedures required to support GMP operations, Collaborate with Talent Acquisition to identify outside agencies to help support projects on an as needed basis, Collaborate with clients, CMO's, and vendors to meet project and company objectives, Participate in audits and regulatory agency inspections for Validation, Serve as subject matter expert in all aspects of Validation, Lead investigations related to validation discrepancies and assured thoroughness of investigation, documentation, and closure, Create work orders, as needed, to ensure that calibrations, maintenance, and repairs are completed as required, to carry out qualification activities, Managing staff by setting objectives, creating development plans, and completing performance reviews, Collaborate and support the CSV team to validate computer systems Supports and oversee domestic ImmunityBio sites Validation activities Implement qualification practices to align with industry standards and look for streamlined approaches for process improvement and increased throughput Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities. Education and Experience Bachelor's degree in science or related disc