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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
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Senior Analytical Development Scientist Job

Date: Jul 31, 2019

Location: Fremont, CA, US

Company: Novo Nordisk

About the Department
Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s decease and chronical heart failure.


The Position
The Senior Analytical Development Scientist is responsible for developing, establishing and maintaining methods analyzing in-process samples and final products to ensure assays are available for process development and manufacture, and are carried out within the framework of established policies, procedures and guidelines.


Relationships
The Senior Analytical Development Scientist will work at the Chemistry, Manufacturing and Control (CMC) Stem Cell Manufacture facility located in Fremont, California. The Senior Analytical Development Scientist will report to a member of the Stem Cell Manufacture Leadership Team. Internal stakeholders include employees in R&D in Novo Nordisk A/S, employees of University of California, San Francisco (UCSF), and employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality.


Essential Functions
  • Work with Process Development to guide early assay selection, development and transition into Quality Control
  • As needed, develop novel assays to characterize cell function, potency and phenotype
  • Optimize assays for use in routine screening or by Quality Control
  • Provide guidance on technical aspects of analytical methods, trouble-shoot and provide technical support for assays by exercising sound judgement and effective prioritization of options
  • Take lead role in working with contract development and manufacturing organizations (CDMO) on assay development
  • Introduce new techniques and assay platforms as needed
  • Act as subject matter expert on analytical methods
  • Perform projects individually or as part of a team
  • Lead qualification and validation of analytical methods critical to the characterization of the identity of, purity of, impurities in and potency of drug product per International Conference on Harmonisation (ICH) and other guidelines while maintaining thorough documentation
  • Lead identification and development of analytical methods to develop in-process control and understanding of stem cell differentiation processes to support in-process testing and comparability studies
  • Write technical documents (standard operating procedures (SOPs), TPs, development and qualification protocols and reports, etc.)
  • Publish and present results internally and externally, as appropriate
  • Support activities in other departments as requested

Physical Requirements
Ability to work flexible hours as necessitated by the process. Approximately 20% overnight travel.


Qualifications
  • Ph.D. in scientific field, or equivalent field, with 6 or more years relevant experience required (Master’s with 10 or more years of experience, may be considered)
  • A minimum of 5 years of experience in cell-based, biochemical or molecular assays required
  • Experience with characterization of cell function and phenotype, including imaging, flow cytometry, qPCR, genomics, proteomics and ELISA preferred
  • Substantial knowledge of embryonic stem cells and their differentiated products preferred
  • Experience with method validation and transfer preferred
  • Strong organizational, trouble-shooting, communication and interpersonal skills are essential
  • Ability to work on fast-paced, collaborative teams and demonstrate flexibility in response to changing priorities is a must
  • Ability and desire to support the team with additional tasks as needed

Novo Nordisk is an Equal Opportunity Employer /F/Veteran/Disability/Sexual Orientation/Gender Identity.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.


Requisition ID: 60182BR
State/Provinces: Fremont
Job Category: Research


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

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