ImmunityBio

ImmunityBio

BioProcess Engineer II, Downstream

Louisville, CO · Mid

Sponsorship not specifiedDetected 15 days ago
Customer SupportGMPFDA RegulatoryCRISPRCommunicationCollaborationProblem SolvingTime ManagementWritingMicrosoft Office

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odds of building a lasting career here

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Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

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Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

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About the role

  • 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.
  • 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.
  • 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.

Responsibilities

  • 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.
  • 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.
  • 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.
  • Provide technical support during tech transfer and scale-up to the cGMP suite, and support troubleshooting and mitigation efforts for GMP manufacturing situations.
  • 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.
  • Perform column packing and qualification (HETP/asymmetry), establish dynamic binding capacity, resin lifetime, cleaning, and sanitization strategies, and define operating ranges for chromatography steps.
  • 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.
  • 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 filtration (clarification, TFF and sterile filtration) required.
  • Extensive hands-on experience in process-scale chromatography 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).
  • 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.

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
  • Skills in sterile filtration and filter integrity testing, filter sizing studies, and filter compatibility for viral vector products.

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.
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This listing is sourced directly from ImmunityBio's careers page and normalized into a canonical job model.