ImmunityBio, Inc. is a late-stage immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious disease. The company’s immunotherapy platform is designed to activate both the innate (natural killer cell and macrophage) and adaptive (T cell) immune systems to create long-term “immunological memory.”
Associate Director, Bioanalytical
The Associate Director will be responsible for developing and implementing bioanalytical assays including immunogenicity and biomarker assays in support to the Vaccine and Cell Therapy programs. The incumbent will serve as a scientific expert and leader in bioanalysis for the organization and will oversee technical and regulatory strategies for the implementation of bioanalytical assays for nonclinical and clinical development programs. Individual will also develop and implement innovative approaches to assess the phenotype, function, potency, and functional attributes of engineered NK-cells with the aim of establishing appropriate characterization and analytical control strategies. Proven track record of providing leadership to accelerate clinical product development, implementing best-in-class bioanalytical testing strategies that are compliant to regulatory requirements.
- Design and develop all aspects of preclinical and clinical bioanalysis including de novo assay development, optimization, and troubleshooting
- Support all bioanalysis efforts for preclinical and clinical studies, including biological activity, pharmacokinetic, pharmacodynamic/biomarker, and immunogenicity analysis
- Serve as a bioanalytical representative in nonclinical and clinical teams as needed
- Manage method development/transfer, optimization, validation, critical reagent supply and assay lifecycle management; enable stage-appropriate bioanalytical support for internal and external partners and programs
- Review, present and report results to internal/external teams and in internally authored technical reports
- Design, author and review method validation plans, method qualification and validation reports, sample analysis plans and bioanalytical study reports
- Develop operational work plans including requests for proposals/quotes, tracking of project milestones, timelines, develop risk mitigation strategies and technical troubleshooting
- Manages and maintains equipment, reagents and dedicated laboratory environment needed to carry out assignments
- Provides guidance and mentorship to less experienced colleagues and acts as a technical advisor; demonstrated leadership abilities through project leadership and mentoring.
- Work with a cross-functional team to advance clinical development of NK cell therapy products
- To work with key stakeholders to establish a Quality system for the analytical development and testing groups.
- To provide analytical development and testing subject matter expertise in the writing and review of all the regulatory submission documents.
- Major in Cell Biology, Immunology, Biochemistry and biological sciences or engineering
- PhD with 6+ years or MS with 12+ years or BS with 15+ in a relevant life science discipline and having experience in the biopharmaceutical industry, preferably in biologics drug or cell therapy
- In-depth experience in ligand binding assay development (e.g. ELISA, ECL/MSD)
- Knowledge of assay development and validation, and understanding GXP requirements and ICH guidelines to support the regulatory approval process
- Experience authoring reports/presentations
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
- Ability to think critically and demonstrate troubleshooting and problem solving skills
- Experience with immunoassay technologies such as, flow cytometry, ELISA, MSD, DD-PCR and Luminex
- Excellent interpersonal, verbal and written communication skills
- Excellent skill in DOE, Microsoft word, Excel, Jmp, Prism, FlowJo and data analysis
*All hires are based upon completion and passage of a background check.
ImmunityBio is a mandatory vaccination employer for COVID-19 and its variants. The Company requires that its employees be fully vaccinated as of their start date. If you require a medical or religious accommodation we will engage in the interactive process with you. Proof of vaccination will be required prior to start. If we make you an offer and you are not yet vaccinated, we will accommodate a delay in start date. ImmunityBio may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.