Research Associate I, Analytical Development

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, quick learner, and organized person.
• Good interpersonal, verbal and written communication skills.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Proven ability to be highly productive and successful in a fast-paced work environment with excellent attention to detail, ability to think critically and troubleshoot/problem solve.

Working Environment / Physical Environment

This position works on site in Louisville, CO. Regular work schedule is Monday – Friday, within standard business hours. Working environment is within a GMP BSL-2 laboratory with sufficient equipment to complete the tasks described above. Frequently working on the computer for data analysis. Occasionally lifting/carrying up to 40 lbs; frequent bending, sitting, squatting.