
Specialist, Quality Control Analytical
ImmunityBio, Inc. (NANTKWEST, Inc.)
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Job overview
The Specialist, Quality Control Analytical provides testing support for fusion proteins, cell therapies, and cancer vaccines, including in-process and suitability-for-use testing. The role also supports method development, optimization, and investigations, and handles complex troubleshooting. It creates testing protocols and reports, performs laboratory support, and contributes to quality systems and documentation.
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Full job description
Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. 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 SummaryThe Specialist, Quality Control Analytical will provide testing support for various programs (fusion proteins, cell therapies and cancer vaccines), which can include but is not limited to, wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA. The position will be responsible for providing testing support through In Process testing, and suitability for use testing, method development, optimizations, and investigational studies. The Specialist will undertake complex troubleshooting and investigations.Essential Functions * Provides testing support through In Process, and suitability for use testing * Provides support for method development, optimizations and investigational studies. * Creates testing protocols and reports * Performs lab maintenance and lab support Functions including completing maintenance records and deliverables * Provides quality systems and documentation support and completes change controls, standard operating procedures (SOPs) and test method updates, and associated documents * Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.Education & Experience * Bachelor's degree in Biochemistry or related discipline with 4+ years of experience in the Biotechnology industry required; or * Master's degree in Biochemistry or related discipline with 2+ years of experience in the Biotechnology industry required * Hands-on experience with HPLC and ELISA preferred * Must have experience working in cGMP laboratoryKnowledge, Skills, & Abilities * Strong interpersonal, communication, organizational, and problem-solving skills * Working knowledge of QC testing requirements, methodology, and general equipment such as pH meter and analytical balance * Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics * Ability to be flexible and manage multiple priorities in a fast-paced environment * Ability to thrive in an efficient, highly interactive, goal-oriented team environment * Knowledge of MS Word and ExcelWorking Environment / Physical Environment * This position works on site in Dunkirk, NY * Flexibility in working schedule, i.e., off-hours * Exposure to onsi
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