Principal Scientist, Analytical Development - Cell Therapy

Company: Celgene
Location: Seattle
Posted on: February 17, 2020

Job Description:

Req #:
Location: Seattle, Washington, United States
Job Category: Technical Development
Work Location: 400 Dexter Ave N. 98109
Organization: Bioengineering
Employee Status: Full-time
Job Type: Regular
Juno Therapeutics, a Celgene company, is developing clinical-stage, novel cellular immunotherapies based on two distinct and complementary platforms Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body s immune system to treat cancer.

We are recruiting a Department Leader for Cellular Analytics in Cell Therapy Analytical Development organization. S/he will work with a talented and experienced team to enable the rapid advancement of cellular therapy candidates from pre-clinical development through commercialization. In addition to proven leadership capabilities, the successful candidate should have experience in the development and implementation of analytical methods for cell analysis, including flow cytometry, as well as assessment and implementation of new technologies. The incumbent will provide strategic direction for the department to establish platform cell analysis strategies, analytical method lifecycle management, and development and implementation of novel technologies. This leader will report into the head of Analytical Development.

Responsibilities will include, but are not limited to, the following:

• Direct all activities of the flow cytometry assay function, consisting of scientists and research associates. Ensure the recruitment, mentorship and training of staff. Provide scientific and technical guidance to analytical development programs in support of the development, characterization, qualification, GMP implementation and scale-up of cell analytics methods.
• Balance resource allocation based on project priorities. Communicate effectively to staff and key partners and stakeholders.
• Oversee the design, development, and qualification of analytical methods to assess cellular product identity, purity, quality and potency. Collaborate with other Analytical Development (AD) departments to ensure the overall analytical strategy is complete and phase appropriate as a member of the AD leadership team.
• Coordinate, lead and participate in various aspects of method development, transfer, characterization, investigation and assay validation while collaborating with Cell Therapy Technology, QC, Process Development, Clinical and Commercial Manufacturing, and Quality Operations teams.
• Provide scientific guidance to development operations, and clinical and commercial QC teams. Main t ain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to current and future Cell Therapy Development operations and products.
• Provide key strategic compliance and analytical development input to projects and cross-functional teams, including process development, manufacturing implementation, IMPD and IND preparation, and discussions with regulators.
  Skills/Knowledge Required :
  
  • PhD in Immunology, Biological Science, Biochemical Engineering, or related discipline with 10 yrs R&D / analytical development experience, or BS/MS with 15+ yrs R&D / analytical development experience in a relevant field.
  • Established track record of success, sound technical qualifications and knowledge in flow cytometry. Cell therapy product characterization, method bridging, and other analytical technology experience a plus.
  • Solid understanding of the fundamentals of assay characterization, qualification, and transfer.
  • Familiarity with and constant attention to the evolving landscape through literature review/publication, conference attendance, industry working group leadership, etc.
  • Strategic thinker with excellent problem solving and conflict resolution skills.
  • Ability to foster a strong team-first environment with the ability to lead multiple projects.
  • Demonstrated success in leading high performing assay development teams.
    
    About Us
    
    COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
    
    At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
    
    "At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."
    
    There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies. Associated topics: bioengineering, biomaterials, biomedical, enzyme, fermentation, hereditary, medical, molecular, pathogenesis, therapeutic

Keywords: Celgene, Seattle , Principal Scientist, Analytical Development - Cell Therapy, Healthcare , Seattle, Washington