Research Associate I, Analytical Development

NKW ImmunityBio; Louisville (CO); On-site; USD 55,000 - 85,000; Full time

Job summary

ImmunityBio is seeking a Research Associate I to join the Process Science team. You will contribute to developing and implementing processes across ImmunityBio's platforms, supporting drug substance and product production, and coordinating with Manufacturing, QA, QC, and Process/Product Development teams.

The role requires bachelor’s-level biology or biomedical engineering education, lab experience, and familiarity with analytical methods.

Qualifications

• Bachelor's degree in biological sciences or biomedical engineering.
• Some experience in a research lab setting and/or a regulated pharmaceutical environment preferred.
• Previous training in handling and maintaining mammalian cell culture in a BSL-2 laboratory is a plus.
• Previous training in data analysis is a plus.

Responsibilities

• Assist in and provide support to engineers and scientists in Process Development of bench-scale upstream and downstream unit operations.
• Assist in and provide support to engineers and scientists for methods development, optimization, and troubleshooting of analytical methods.
• Collaborate in data collection and interpretation from bench-scale experiments and large-scale manufacturing data.
• Set up bench-scale experiments, including preparing buffers, solutions and assay reagents.
• Analyze and document experimental data in lab notebooks in a timely and accurate manner.

Skills

Aseptic technique

Data analysis

MS Office

Lab documentation

Education

Bachelor's degree in Biological sciences

Tools

Excel

GraphPad Prism

JMP

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 Summary

The Research Associate I will work as part of the Process Science team at ImmunityBio to contribute to our efforts to develop and implement processes and methods across ImmunityBio's platforms, and the advancement of our pipeline by collaborating with internal and external partners. The role will assist with process and method development, provide support for the production process of drug substance and drug product, and require timely execution of samples in support of all development activities. The Research Associate I will assist in data review, process unit operations, method qualification and/or validation and will require cross-functional interaction with members of the Manufacturing, Quality Assurance, Quality Control, and Process/Product Development teams.

Essential Functions

• Assist in and provide support to engineers and scientists in Process Development of bench-scale upstream and downstream unit operations.
• Assist in and provide support to engineers and scientists for various product platforms, process improvements and efficiencies in method development, optimization, and troubleshooting of analytical methods.
• Participate in the collection and interpretation of data from bench-scale experiments and large-scale manufacturing data with guidance and oversight from supervisor or manager.
• Set-up bench-scale experiments, including preparing buffers, solutions and assay reagents, with guidance and oversight from supervisor or manager.
• Analyze and document experimental data in laboratory notebooks in a timely and accurate manner in accordance with the company guidelines.
• Perform a variety of techniques to assess product quality and characterize products, including UV-Vis, osmolality, pH, conductivity, Karl Fischer analysis, other analytical chemistry techniques as well as routine maintenance of various mammalian and bacterial cell cultures.
• Perform analyses in a BSL-2 laboratory, handling BSL-2 microorganisms while working in a biological safety cabinet.
• Support internal and/or external transfers of analytical methods and feasibility testing.
• Generate and organize process and analytical data using software like Excel, and GraphPadPrism or JMP for data trending.
• Perform general duties to clean, maintain, calibrate and operate analytical and process equipment and instruments, as required.
• Clean and autoclave glassware and lab equipment, as needed.
• Support routine and non-routine laboratory and process development operations.
• 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 sciences or biomedical engineering required.
• Some experience in a research lab setting and/or a regulated pharmaceutical environment preferred.
• Previous training in handling and maintaining mammalian cell culture in a BSL-2 laboratory is plus.
• Previous training in data analysis is a plus.

Knowledge, Skills, & Abilities

• Basic skills in aseptic/sterile techniques, basic wet chemistry and laboratory best practices.
• Competency in computer skills and familiarity with Microsoft Office programs (Word, Excel, PowerPoint) and strong technical writing skills.
• Exhibit a proactive, can-do attitude and commitment to team success.
• Attention to detail, qui