Jobs at ImmunityBio

Support analytical development for adoptive cell therapy projects by performing immunological and biochemical assays (ELISA, MSD, flow cytometry), cell culture, mycoplasma/endotoxin testing, data analysis and documentation, maintain lab operations and compliance, and assist cross-functional projects.

Support process and analytical development for adoptive cell therapy projects by performing immunological and biochemical assays (flow cytometry, ELISA, MSD, ELISpot), cell culture, mycoplasma/endotoxin testing, data generation and trending using Excel/JMP, and maintaining regulatory-compliant laboratory records and general lab operations.

Lead and oversee statistical programming for clinical trials: create, validate, and maintain analysis datasets and outputs; review SAPs and dataset specifications; prepare electronic regulatory submissions; develop/validate global macros; standardize data (CDISC SDTM/ADaM); mentor junior staff; contribute to process improvements and resource planning.

Lead end-to-end delivery of facility, utility, and equipment capital projects for GMP manufacturing. Own planning, budgets, schedules, CQV/IQ-OQ-PQ coordination, vendor management, construction oversight, risk mitigation, cross-functional alignment, and handover to operations in a regulated biotech environment.

The Senior Biostatistician will oversee statistical analyses and reporting of clinical trial data, ensuring quality and compliance with regulatory standards while mentoring junior staff.

The Principal Statistical Programmer manages statistical programming for clinical trial data, ensures quality and compliance for CDISC standards, and mentors junior staff.

The DevOps Engineer role focuses on integrating continuous delivery practices, maintaining CI/CD pipelines, collaborating with teams on infrastructure automation, and ensuring compliance standards.

Lead global labeling strategy and maintenance from clinical development through commercialization. Draft and maintain USPI/SmPC, ensure regulatory and GMP compliance, coordinate cross-functional stakeholders, manage label content/artwork updates with manufacturing/vendors, respond to Health Authority questions, and develop labeling specifications, change controls, and proofs.

Lead and manage global labeling strategy and team from clinical development through commercialization. Oversee preparation and maintenance of labeling documents (USPI, SmPC), ensure regulatory and GMP compliance, coordinate artwork and packaging updates with manufacturing and vendors, respond to health authority comments, draft label specifications, train staff on SOPs, and collaborate cross-functionally on CMC and labeling matters.

Manage day-to-day administration and support for GxP computerized systems, ensuring compliance with regulations and providing technical leadership for system deployments and upgrades.

Lead development, qualification, and transfer of analytical methods for proteins, viral vectors, and cell therapies. Mentor and manage a process sciences team, author regulatory CMC documentation, support process development and QC/QA interactions, perform HPLC/biochemistry assays, formulation/stability studies, and oversee lab instrumentation and contract testing compliance.

Support QC stability and reference programs by scheduling tests, entering and trending data, performing basic statistical analysis, drafting protocols and reports, packing/shipping materials, maintaining logs and stability chambers, assisting regulatory submissions (IND/BLA), and supporting quality systems including SOP updates and change requests.

Manage Product Development laboratory operations including equipment maintenance, supplies purchasing and inventory, SOPs, vendor management, team hiring/training and supervision, EHS support, and coordination of sterility/bioburden testing and lab information systems.

Manage cell therapy product development projects end-to-end using project management methodology: define scope, schedule, resources; lead cross-functional teams; track progress, risks, and budgets; report to stakeholders; improve processes and support ad-hoc initiatives.

Serve as strategic HR partner to leadership, advising on employee relations, performance management, compensation, recruitment, training, policy compliance, and HR projects. Conduct investigations, report people metrics, and ensure alignment of HR practices with business objectives.

Provide legal support for clinical trials by drafting, reviewing, and negotiating CTAs and related agreements; advise on regulatory, data privacy, IP, indemnification, and payment terms; develop templates, playbooks, and policies; manage vendor/CRO contracts; ensure compliance with FDA, GCP, HIPAA, GDPR; support due diligence and CLM improvements.

The Regulatory Affairs Program Manager leads cross-functional regulatory projects, ensuring products meet global regulatory requirements and are launched on schedule.

Perform molecular biology and protein/RNA production to support immunotherapy R&D: cloning, PCR, plasmid prep, in vitro transcription, protein expression/purification, data recording, SOP adherence, and train junior staff.

Provide legal support for clinical research by drafting, reviewing, and negotiating Clinical Trial Agreements and related vendor and commercial contracts. Ensure compliance with FDA, GCP, HIPAA, GDPR and other regulations; develop templates, SOPs, and negotiation playbooks; advise internal stakeholders on risk mitigation; assist with informed consent review; deliver training and lead process-improvement and cross-functional projects.

The Associate, Manufacturing supports biological manufacturing by adhering to cGMP guidelines, executing manufacturing processes, and collaborating cross-functionally to ensure quality operations.