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Senior Scientist , Bioanalytics, Gene Therapy, Assay Development and I

Company: CSL Behring
Location: Pasadena
Posted on: March 20, 2020

Job Description:

About CSLWith operations in 35+ nations and - 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!Job DescriptionSummary of Role --- To develop test methods from first principles for characterization and product release of cellular and gene therapies --- Develop cellular and molecular assays comprising the following skill sets and techniques: isolation and culture of primary human CD34 HSPC. In vitro expansion and lineage differentiation cultures, CFU assays, cell potency assays, immunophenotyping, and functional Flow Cytometry, --- Develop HSC expansion and self-renewal culture conditions that correlate with long term engraftment. --- Develop single cell technologies and high throughput molecular screens of small molecules that enhance transduction, --- Develop Biochemical and multiplex immunological assays. --- Troubleshoot assay methods as required --- To qualify and validate molecular and cellular analytical methods according to established guidelines. --- To provide analytical support of product development activities, release tests, and/or patient sample analysis where required and report results --- To transfer assays internally and externally where required --- To maintain laboratory quality systems and records of analytical results. Responsibilities:

  • Develop analytical methods suitable for characterisation, release testing, and stability testing of cell therapies
  • Qualify and validate analytical methods for release testing and stability testing of cell therapies
  • Prepare test procedures, standard operating procedures (SOPs) and data collection forms, where required.
  • Present progress updates and experimental results at project meetings
  • Work independently and as part of a team
  • Consult/Collaborate with other scientists as required on assay design and execution to leverage resources and make use of other Scientists' expertise
  • Perform Technical Transfer of methods in and out of department.
  • Seek out and research new technologies and laboratory practices to enhance the groups capabilities and to be aware of and utilize as appropriate, current international standards
  • Maintain records of all laboratory work to Good Scientific Practice (GSP) and Good Manufacturing Practice (GMP) standards, as required
  • Implement and support Quality Systems within Bioanalytical Sciences, and ensure department compliance with GSP and GMP standards, as appropriate
  • Initiate change controls for documents or procedures, closing out change controls by training of staff.
  • Ensure routine maintenance and repairs on scientific instrumentation, as required.
  • Ensure critical instruments are calibrated and calibration records maintained.
  • Ensure high safety standards within the areas of responsibility are taken into account and adhered to as governed by local, state and federal regulations, laws and policies as well as CSL's policies and directives Essential Qualifications/Experience:
    • An M.D. or Ph.D degree with training in Gene Therapy, experience in Molecular Biology, Immunology, Biomedical engineering, or a related field, including relevant postdoctoral training.
    • At least five years laboratory experience in Stem Cell or Immunology Research with an emphasis on assay development and analytics preferably working in a multidisciplinary systems biology environment. Expertise in Hematopoietic Stem and Progenitor Cell (HSPC) Biology, Cellular and Gene Therapy is preferred.
    • Candidates with a strong record of scientific accomplishments are preferred.Essential Skills, Knowledge & Attributes
      • Expertise in HSPC biology and hematopoiesis, isolation and culture of human CD34 HSPC from mobilized peripheral blood and BM MNCs. Cell subset enrichment, flow sorting, stem cell biomarkers, and functional cellular assays.
      • Experience in multicolour flow cytometry, immunophenotyping, phopho-flow, including advanced data analysis and visualization tools.
      • Experience in viral gene transfer, transduction, transfection of reporter constructs, si/shRNA screens, gene editing technologies.
      • Experience in DNA and RNA isolation, qPCR, RT-qPCR, multiplex qPCR, ddPCR, and recombinant DNA methods.
      • In depth understanding of Next Generation Sequencing and omics technologies, scRNA-Seq methods, and bioinformatic methods and visualization tools for analysis of NGS data sets.
      • Competence in data analysis and statistical methods
      • Scientific report writing and presentation skills
      • Outstanding verbal and written skills
      • Writing SOPs and assay qualification/validation plans.
      • Good Documentation Practices
      • Understanding of GLP/GMP/GCLP regulatory requirements in cell and gene therapy.

Keywords: CSL Behring, Pasadena , Senior Scientist , Bioanalytics, Gene Therapy, Assay Development and I, Healthcare , Pasadena, California

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