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."
The Scientist, Vaccine Product Development will assist other team members with researching and developing manufacturing processes related to numerous expression system-based immunotherapies, including self-amplifying RNA (saRNA) and viral vector platforms. The Scientist, Product Development will primarily be involved in the characterization, optimization, troubleshooting, and validation of such clinical and/or commercial manufacturing processes. The role includes performing bio-assay development experiments, the careful documentation of methods and materials and results, writing technical reports, and effectively communicating findings to other teams. The ideal candidate will have a breadth of expertise in Molecular Biology, RNA Biology, Cell Biology, tissue culture and cell-based methods, with a proven track record of achievement. The successful candidate will possess excellent organizational skills and have strong attention to detail, be proficient in communication (written and verbal), is timeline focused as well as flexible in their work scheduling to meet the demands of a multi-product clinical phase biopharmaceutical company that is transitioning to the commercial phase.
* Supports daily tasks in the Vaccine Product Development group, including method and protocol development, and characterization of novel immunological and biochemical technologies.
* Conducts daily tasks associated with the characterization of our novel vaccine vectors.
* Work directly and professionally with other scientists and research associates to coordinate product development experiments.
* Performs routine human tissue-culture maintenance within the BSL2 facility.
* Conducts immunological in-vitro assays to support our vaccine discovery/ development programs and translational strategies.
* Acts as an independent study technician while interacting with senior team members, preparing study calendar and notebooks, recording raw data on worksheets and electronic notebook, test article preparation and handling records.
* Efficiently and accurately conducts assigned test procedures within constraints of lab scheduling.
* Meticulously maintain experimental records, analyze data, and prepare study reports.
* Conduct additional laboratory work as needed within the group, or as assigned by other senior group members.
* Maintain strong professional communication with managers, team leads, and research associates to facilitate on-time project completion.
* Perform problem-solving for issues pertaining to GMP production
* Provide cGMP and equipment SOP training and coaching when qualified.
* Aid in the generation of QC and QA executed manufacturing batch records for compliance.
* Support validation team for facility and equipment validation.
* Aid in the characterization and optimization of our RNA based vaccine platform
* Aid in the generation of new viral seed stocks (VSS) used upstream in the manufacturing process for the Ad5-platform.
* Manage work related to assigned programs and collaborate with downstream, analytical, quality, and manufacturing colleagues.
* Supervise and train research associates or technicians as needed.
* BS in a scientific discipline (Biology, Molecular Biology, Biochemistry or similar) with 7-10 years of industry work experience.
* MS in a scientific discipline (Biology, Molecular Biology, Biochemistry or similar) with at least 5 years of industry work experience.
* Ph.D. in a scientific discipline (Biology, Molecular Biology, Biochemistry or similar) with at 1-3 years of industry work experience.
* Experience with molecular sub-cloning methods (PCR, restriction digest, DNA preparation), and gene expression assays (SDS-PAGE, Western Blot).
* Strong experience working directly with mRNA, including in-vitro transcribed mRNA, molecular cloning, maintenance of mammalian cell lines, and in vitro immunological assays, such as ELISA, immunostaining and flow cytometry.
REQUIRED COMPETENCIES - KNOWLEDGE, SKILLS, ABILITIES
* Working with RNA (mRNA, rRNA, saRNA, siRNA, miRNA, etc.)
* Working with BSL-2 viral-vectors
* Tissue Culture of primary cells
* Current Good Manufacturing Practices
* QC.QA-documentation requirements
* Possess good interpersonal and strong written/verbal communication skills.
* Excellent skills in prioritizing and time management.
WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS
* Working environment is within an approximately 2,000 square foot space with equipment sufficient to compete with the tasks described above.
* Occasionally: Transporting small equipment required
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.