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Scientist II - III, AMD - Immune Oncology

LOCATION:  This position will initially be located in our Point Richmond facility and then relocate to Brisbane.  We anticipate opening our Brisbane facility in late 2018 / early 2019.   JOB SUMMARY:    The Analytical Methods Development (AMD) scientist will perform laboratory-based activities to design, develop and qualify analytical methods for the characterization, release testing and stability testing of the Company's recombinant Adeno-associated Virus (rAAV) Gene Therapy, Genome Editing, and Immune-Oncology Cell Therapy products. Ideal candidate will be experienced, hands-on individual can independently perform cGMP compliant analytical methods development for Gene & Cell Therapy product characterization, lot release and stability studies. The successful candidate will be responsible for analytical method development, assay optimization, qualification and validation. Participating cross-functional project team, representing AMD function, management of tech/methods transfer to in-house QC department as well as external contract manufacturing organization (CMO), contract testing organizations (CTO).   ESSENTIAL FUNCTIONS:  Development & qualification of cGMP method development for gene & cell therapy product characterization, lot release and stability testing Proficient with flow cytometry, cell culture techniques, cell-based assays and immunoassay Serve as technical resource for analytical method issues. Guide characterization of products including preparation of reference standards, and assay development plans Develop and implement cellular characterization assays including Immune Cell Phenotyping, T-cell function, DNA sequencing (sanger or NGS) Design and execute laboratory-based assay development, qualification and validation. Develop and qualify potency assays, set assay acceptance criteria and product specifications by applying appropriate statistical tools and comply with regulatory guidelines Drafting and reviewing of SOPs, development report, test records and protocols to facilitate transferring methods and training staff of the QC department or CTOs Assist in the preparation of CMC regulatory submissions Other activities as may be assigned   EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:The ideal candidate for this position will have demonstrated in-depthexperience of the development,qualification, validation and implementation of analytical methods for the characterization, release testing and stability testing of biologic products in an industry setting.Candidatemust possess: Ph.D. in Immunology, Cancer Immunology, Cell Biology, Biological Sciences, or biochemistry Minimum 5 years of experience in the biotechnology or pharma industry with a primary focus on AMD for biologic products Up-to-date knowledge in immunology and oncology is required Experience with flow cytometry, and proficiency with FlowJo or FACSDiva software for data analysis, cell culture techniques, cell-based assays and immunoassay is must Expertise in developing and executing cellular characterization assays including Immune Cell Phenotyping, T-cell function, DNA sequencing (sanger or NGS) are highly desired Drug development experience using AAV gene transfer, CAR-T platform is preferred A strong commitment to experimental work is essential, as well as the ability to independently identify and solve complex problems to advance projects through the development process Demonstrated expertise in the independent design and execution of analytical development projects, DOE and statistics for data analysis Strong verbal and writing skills including data documentation, project presentation, drafting technical reports, and communication of progress to manager OTHER REQUIREMENTS: Specific experience with quantitative analytical techniques including qPCR, ddPCR, ELISA and fluorescence-based enzymatic assays Sound understanding and demonstrated application of statistical methods/tools Knowledge and good understanding of FDA, EMA, cGMP, WHO and ICH regulatory requirements Excellent interpersonal skills, outstanding organizational skills Excellent written and oral communication skills Strong analytical, organizational and communication skills The above reflects management's definition of essential functions for this position, but does not restrict the tasks that may be assigned.The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.   Key functional words: Research, Manufacturing, Biotechnology
Salary Range: NA
Minimum Qualification
5 - 7 years

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