Scientist II - III, AMD - Immune Oncology

Sangamo BioSciences   •  

Richmond, CA

Industry: Pharmaceuticals & Biotech

  •  

5 - 7 years

Posted 171 days ago

This job is no longer available.

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 and qualification of cGMP analytical methods for gene & cell therapy product characterization, lot release and stability testing
  • Serve as technical resource for analytical method issues. Guide the analytical characterization of products including preparation of reference standards, assay development plans, DOE and statistics for data analysis
  • Design and execute laboratory-based analytical 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-depth experience 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.Candidate must possess:

  • Ph.D. in Immunology, Cancer Immunology, Cell Biology, Biological Sciences, or biochemistry
  • A minimum of 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
  • 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