ImmunityBio, Inc. (NANTKWEST, Inc.) logo

Senior Scientist, Quality Control Analytical

ImmunityBio, Inc. (NANTKWEST, Inc.)

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At a glance

Compensation
No compensation found
Location
DUNKIRK, NY
Work Authorization
Not specified

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Job overview

The Senior Scientist, Quality Control Analytical provides analytical testing leadership for programs including fusion proteins, cell therapies, and cancer vaccines. The role supports analytical chemistry methods across development and commercial programs, including method development, optimization, transfer, qualification, and investigations. It also serves as a subject matter expert within QC and leads complex troubleshooting and analytical investigations.

Skills & qualifications

RequiredNice to have

Skills

Wet ChemistryHPLCCapillary ElectrophoresisUV-Vis SpectroscopyELISAMethod DevelopmentMethod OptimizationMethod TransferMethod QualificationAnalytical TroubleshootingAssay DevelopmentAnalytical ChemistryStructural CharacterizationRoot Cause Analysis

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 Senior Scientist, Quality Control Analytical provides analytical testing leadership for various programs such as fusion proteins, cell therapies and cancer vaccines. The analytical testing will include but is not limited to the wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA. The position will also take on a lead role for providing testing support through In Process testing, and suitability for use testing, method development, optimizations, transfer, qualification work and investigational studies. The Senior Scientist will undertake complex troubleshooting and investigations.Essential Functions * Develop strategies, and support the introduction, validation and on-going technical agenda for pipeline and commercial analytical chemistry methods and technology. Including: * The polishing of analytical methods to implement GMP-friendly structure into the method. * Drafting and reviewing of protocols, reports, and methods to support the method validation lifecycle. * Complex troubleshooting of methods * Development of new assays to support raw material, in process, drug substance, or drug product release and stability testing. * As required, provide training or mentorship to other QC or cross functional team members. * Act as Subject Matter Expert (SME) for analytical chemistry within QC. This may include the identification, purification and separation of the components in an unknown mixture. * Complete structural analytical characterization (via experimental analysis or review of outsource reports) on various drug products, including product related impurities. * In the event of non-conformance to acceptable quality and/or safety standards (including invalid assays), lead analytical investigations, using Root Cause Analysis techniques where appropriate. Work with the QC team to improve the state of validation and drive analytical variability reduction. * Draft and edit documents, Standard Operating Procedures (SOPs) and test plans as needed. * Lead continuous improvement activities to help improve the overall operations of the testing labs. * Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence. * Partner with colleag

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