BioProcess Engineer II, Upstream

ImmunityBio

Louisville, CO

Pay: $99,100-$109,000/yr

Shift: Full time

**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 BioProcess Engineer II, Upstream role is responsible for process development, engineering, and technical support of upstream viral vector manufacturing for the Company’s gene therapy programs. This position serves as a technical expert for cell culture and bioreactor unit operations, from cell bank thaw and seed train expansion through transfection/infection, vector production, and harvest. The individual will design and execute process development experiments, lead scale-up and scale-down activities, and use a data-driven approach to troubleshoot manufacturing issues, identify root causes, and implement improvements, working cross-functionally to deliver a robust and scalable clinical production process.

**Essential Functions**

• Serve as the process owner/subject matter expert for upstream viral vector unit operations, including cell bank thaw, seed train expansion, cell culture in adherent and suspension formats, transient transfection or infection, vector production, and harvest.
• Design and execute experiments (including DOE) to develop, optimize, and characterize upstream processes for viral vectors with the goal of improving cell growth, productivity, vector titer and quality.
• Lead scale-up of upstream processes from bench scale to pilot and cGMP manufacturing scale (e.g. shake flasks, benchtop, and single-use stirred-tank bioreactors up to 200L), applying engineering scale-up principles such as P/V, tip speed, kLa, mixing time and gas sparging strategy.
• Develop, qualify, and maintain representative scale-down models to support process troubleshooting, process characterization, and robustness studies.
• Operate and support bioreactor systems including set-up, inoculation, monitoring, and control of critical process parameters (pH, DO, temperature, agitation, feed, gassing).Participate in the collection, trending, and interpretation of data from bench scale experiments and large-scale manufacturing, and aid in organization of data for statistical process control.
• Provide technical support during tech transfer and scale-up to internal cGMP manufacturing as well as external CDMO partners.
• Trouble shoot, perform root cause analysis, and recommend corrective and preventive actions for the resolution of deviations, investigations, and process issues.
• Contribute to manufacturing operations, including collaboration with facilities, quality, and manufacturing groups for implementation of the production process in cGMP clinical manufacturing facilities. This can include equipment FAT/SAT, commissioning and qualification, defining user requirements, and support of validation from a process perspective.
• Provide equipment engineering support for upstream processes with a focus on single-use technologies, including support in the creation of custom single-use consumables from design through testing to cGMP operations.
• Draft and review documents including batch records, Standard Operating Procedures (SOPs), qualification protocols, development and tech transfer reports, and investigation reports.
• Meticulously maintain experimental records with detailed observations and maintain laboratory equipment.
• Train Manufacturing personnel and less experienced team members in equipment and process operations.
• Perform ad-hoc and cr