BioProcess Engineer II, Downstream

• 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, Downstream role is responsible for process development, engineering, and technical support of downstream viral vector purification for the Company’s gene therapy programs. This position serves as a technical expert for crude harvest clarification, tangential flow filtration, chromatography, and sterile filtration unit operations, from clarified harvest through purified bulk drug substance. The individual will design and execute process development experiments, lead scale-up of purification processes, 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 downstream viral vector unit operations, including crude harvest clarification, nuclease treatment, tangential flow filtration (TFF), chromatography, formulation/buffer exchange, and sterile filtration.
• •Design and execute experiments (including DOE) to develop, optimize, and characterize purification processes for viral vectors with the goal of improving step yield, impurity clearance (HCP, host cell DNA, introduced reagents) and product quality.
• •Develop and optimize filtration operations, including clarification (depth filtration, centrifugation), TFF (UF/DF with hollow-fiber and flat-sheet cassettes) and sterile (0.2 µm) filtration; perform filter sizing (e.g., Vmax/Pmax), membrane selection, and filter integrity testing.
• •Develop, optimize, and scale chromatography steps, including affinity capture, anion exchange polishing and full/empty separation, and other modes (e.g., CEX, HIC, SEC, mixed-mode) using resins, monoliths, and membrane adsorbers.
• •Perform column packing and qualification (HETP/asymmetry), establish dynamic binding capacity, resin lifetime, cleaning, and sanitization strategies, and define operating ranges for chromatography steps.
• •Lead scale-up of downstream processes from bench scale to pilot and cGMP manufacturing scale and develop representative scale-down models to support process troubleshooting, process characterization, and robustness studies.
• •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 the cGMP suite, and support troubleshooting and mitigation efforts for GMP manufacturing situations.
• •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 downstream processes with a focus on single-use technologies, including support in the creation of custom single-use consumables and assemblies from design through testing to GMP induction.
• •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 cross-functional laboratory work and/or projects assigned to support business needs and provide developmental opportunities.

Education & Experience

• •Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, or related fields with 5+ years of experience in biopharmaceutical process development and/or cGMP manufacturing operations, including direct hands-on experience in downstream processing required; or
• •Master’s degree in Chemical Engineering, Bioengineering, Biotechnology, or related fields with 3+ years of experience in biopharmaceutical process development and/or cGMP manufacturing operations, including direct hands-on experience in downstream processing; MS preferred.
• •Hands-on experience with viral vector purification for gene therapy applications required.
• •Industrial/cGMP experience in filtration (clarification, TFF and sterile filtration) required.
• •Extensive hands-on experience in process-scale chromatography required.
• •Cross training across the entire process of viral vector manufacturing (upstream, harvest, downstream purification, and formulation/fill) is a plus.

Knowledge, Skills, & Abilities

• •Working knowledge of gene therapy principles, including biology and critical quality attributes of viral vector products (vector genome titer, infectious titer, potency, and product- and process-related impurities).
• •Strong expertise in tangential flow filtration (concentration and diafiltration) using hollow-fiber and flat-sheet membranes, including membrane selection, flux/TMP optimization and scale-up.
• •Skills in sterile filtration and filter integrity testing, filter sizing studies, and filter compatibility for viral vector products.
• •Extensive hands-on expertise with chromatography, including affinity, anion exchange (resins, monoliths, and membrane adsorbers), and other chromatography modes; experience with ÄKTA™ systems and UNICORN™ software.
• •Skills in column packing, column qualification, and chromatography scale-up.
• •Familiarity with in-process and release analytics for viral vectors.
• •Good aseptic technique and strong knowledge of cGMP aseptic manufacturing.
• •Must have strong authorship and be able to critically review technical GMP documents, interpret results and generate technical conclusions.
• •Understanding of relevant regulations and regulatory guidance associated with cGMP and gene therapy products, such as 21 CFR 210-211, FDA CBER guidance for human gene therapy products (CMC), ICH Q5A/Q8/Q9/Q11 and USP.
• •Ability to build strong relationships with Quality and Manufacturi