Senior Scientist, Analytical Development AAV

Employer
Celgene
Location
Seattle, Washington, United States
Posted
Sep 14, 2019
Ref
1902085
Required Education
Doctorate/PHD/MD
Position Type
Full time

Req #: 1902085
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 a clinical-stage company developing 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 looking for a Senior Scientist to lead the development of analytical methods of AAV vector in support of allogeneic CART programs. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment. This incumbent is responsible for overseeing development of AAV characterization and release assays at contract manufacturing organizations (CMOs) and contract test laboratories (CTLs) and coordinating the qualification and validation thereof. These analytical methods will be used to support QC release and in-process testing of AAV vector used for CART /TCR gene delivery. The incumbent will plan and coordinate execution of laboratory studies, analyze experimental data, document results, and present findings to CMC and Core teams.

This position requires project leadership and management skills and attention to scientific detail. If you are dedicated to excellence and want to make a difference, we're excited to hear from you!
Job Description:

 

 

  • Coordinate development and qualification analytical methods to enable AAV process development, release and stability testing at CMOs/CTLs
  • Lead the development of AAV control strategy; work with a cross-functional team to design and execute CMC development plan in support of allogeneic CART programs.
  • Oversee the successful design, execution, interpretation, and documentation of experiments.
  • Support AAV process development effort
  • Contribute to development of novel technologies for gene and cell therapy.
  • Author, review, and approve technical documents, including standard operating procedures, QC test methods, and analytical sampling plans.
  • Contribution to regulatory submissions
  • Summarize and present data in cross-functional team meetings


Basic Qualifications:

 

 

 

  • Ph.D. degree in virology, analytical sciences, or related field with 8+ years of experience in AAV analysis and/or drug development
  • Knowledge and experience with AAV biology
  • Demonstrated knowledge of control strategy and analytical development for CMC programs
  • Demonstrated method development experience in techniques such as viral safety and potency assays, viral titer assays, quantitative PCR (qPCR), ELISA, etc.

 

  • Demonstrated skillset in experimental design, data analysis, interpretation, and presentation.
  • Proven ability to work in a fast-paced environment, meet deadlines, & prioritize work on multiple projects. Strong attention to detail with the ability to handle multiple responsibilities simultaneously
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.


Preferred Qualifications:

 

  • Experience interfacing with contract manufacturing and research organizations, GMP contract test laboratories
  • Demonstrated experience in cross-functional and functional leadership roles.
  • Experience with gene engineering of T cells using viral modalities.
  • Experience authoring technical and regulatory documents.
  • Track record of successful internal and external scientific collaborations.

 


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.