ImmunityBio
BioProcess Engineer II, Upstream
Louisville, CO · Mid
Sponsorship not specifiedDetected 15 days ago
Customer SupportGMPFDA RegulatoryCRISPRCell CultureCommunicationCollaborationProblem SolvingTime ManagementWritingMicrosoft Office
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odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- 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.
- 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.
- Contribute to manufacturing operations, including collaboration with facilities, quality, and manufacturing groups for implementation of the production process in cGMP clinical manufacturing facilities.
Responsibilities
- 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.
- 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.
- Develop, qualify, and maintain representative scale-down models to support process troubleshooting, process characterization, and robustness studies.
- Provide technical support during tech transfer and scale-up to internal cGMP manufacturing as well as external CDMO partners.
- Meticulously maintain experimental records with detailed observations and maintain laboratory equipment.
- Perform ad-hoc and cross-functional laboratory work and/or projects assigned to support business needs and provide developmental opportunities.
- Trouble shoot, perform root cause analysis, and recommend corrective and preventive actions for the resolution of deviations, investigations, and process issues.
- 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.
Requirements
- Hands-on experience with viral vector purification for gene therapy applications required.
- Industrial/cGMP experience in upstream cell culture and bioreactor operation required.
- Demonstrated experience with process scale-up and scale-down model development required.
- 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).
- Knowledge of cell banking operations and seed train expansion
- Extensive hands-on experience with upstream equipment such as incubators, biosafety cabinets, cell counters and metabolite analyzers, and single-use stirred-tank bioreactors.
- Strong understanding of bioreactor engineering and scale-up/scale-down principles (mass transfer, mixing, shear, power input, gassing strategy) and qualification of scale-down models.
Nice to have
- Cross training across the entire process of viral vector manufacturing (upstream, harvest, downstream purification, and formulation/fill) is a plus.
Skills
- Knowledge, Skills, & Abilities
Compensation
- The annual base pay range for this position is below.
Company info
- We are committed to equal employment opportunity and ensure that all candidates are assessed based on their qualifications, skills, and experience through human review.
- At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace.
Visa & Work Authorization
- race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law
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This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.