Senior Specialist, Manufacturing GMP Investigations

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 Senior Specialist, Manufacturing GMP Investigations is responsible for writing and owning quality records for GMP Manufacturing Operation activities in support of the release of product. This position provides a unique opportunity to make an immediate impact and lay the foundation for processes and procedures in a fast-paced dynamic environment. Essential Functions Independently manage closure of deviations, ensuring disposition cycle timelines are met and patient supply is maintained. Plan, organize, and prioritize multiple concurrent investigative assignments to ensure deadlines are met and that results are aligned with current business strategy. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Perform analytical, statistical and trending analyses on deviation data to support timely management review and proactive response and implementation of corrective actions. Serve as the primary point of contact for applicable procedures and work instructions related to investigation process; collaborate with subject matter experts (SME’s) and senior management in cross functional departments to adequately evaluate risk and impact. Prepare and present deviation trend data to stakeholders to ensure potential underlying trends are addressed. Lead training for root cause analysis and/or product impact for new investigators. Identify and lead continuous improvement opportunities to reduce repeat and/or recurring deviations. Participate in regular site and Quality/Manufacturing meetings. Participate in audits and regulatory inspections as assigned. Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience Bachelor’s degree in biological science, chemistry, engineering, or related science field required. 4+ years of experience in the pharmaceutical/biopharmaceutical industry required. Experience with biologics cGMP manufacturing ideally including cell therapy cGMP manufacturing required. Facility and Engineering experience/knowledge preferred. Knowledge, Skills, & Abilities Strong knowledge of biologics cGMP manufacturing ideally including cell therapy cGMP manufacturing. Strong verbal, written, and interpersonal communication skills. Proficiency in computer use and Microsoft Office applications. Proven ability to work independently and analyze and resolve issues that impact quality. Attention to detail with strong analytical and problem-solving skills. Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities. Strong decision-making skills with the ability to balance quality/compliance/risk. High level of businesses acumen and ability to work with all levels in the organization. Exceptional organization and time-management skills with the ability to deliver under deadlines. Working Environment / Physical Environment This position works on-site in El Segundo, CA. This position works primarily in an office environment. Regular work schedule is Monday – Friday, within standard business hours. Flexibility is