Senior Associate , Quality Control QCM

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 Senior Associate, Quality Control Microbiology will support the facility environmental and utility monitoring (EM) programs in support of sterile product manufacturing, to include sampling, testing, and data management of the collected samples, training personnel on aseptic technique and aseptic gowning, complete investigations, and support lab operations such as equipment preventive maintenance, supply inventory management, and general support tasks in order to allow the lab to continuously operate. The position will also provide leadership and guidance to junior analysts, support method/SOP revisions, study protocols, method transfers, and qualifications. The incumbent may also support lab assays for lot release and stability testing, participate in sample preparation and aliquoting, media lot release testing. Essential Functions Organize daily workload schedule and relevant resource requirements. Participate in authoring complex, explicit documentation for manufacturing operations. Environmental and Critical Systems monitoring, testing, review, reporting, and trending. Reviewing of data, trending, and applicable investigations. Support all compliance aspect related to microbiological and analytical testing and will support investigations and root cause analysis. Play a critical role in working collaboratively with manufacturing technicians and associates in support of EM. Routine and validation sample testing under GMP or non-GMP modes, laboratory maintenance, and assist in method or equipment qualification/validations. Responsible for laboratory maintenance to include cleaning and sanitization of laboratory equipment, laboratory restocking of supplies and inventory. Coordinate and generate Risk Assessments. Assist with the drafting of controlled documents including Protocols, Reports, SOPs, Test Methods, Specifications and Work Instructions, data entry and reporting Performs 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 a life sciences discipline with 2+ years of experience in a GMP regulated Biologics or Pharmaceutical environment required Experience in cGMP aseptic processing facility is a plus Knowledge, Skills, & Abilities Knowledge of regulatory expectations for QC Microbiology department Knowledge of environmental and critical utilities monitoring, personnel monitoring, aseptic processing, and microbiological testing assays. Fundamental knowledge of microbiology (knowledge of cell and molecular biology, immunology, and virology is a plus). Strong technical writing skills with experience preparing: SOPs, analytical tests reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings. Strong problem-solving skills with demonstrated attention to detail. Good understanding and demonstration of aseptic techniques. Proficient in Microsoft Word, Project, and Excel Ability to perform troubleshooting and develop solutions to problems of moderate scope in complexity. 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. Well-developed written and oral communication skills; motivated to work in a team environment. Ability to operate in a fast-paced, multi-disciplinary industrial environment while managing multiple priorities. Exceptional