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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
USA

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Specialist - Quality Operations Job

Date: Apr 13, 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 Specialist will work at the University of California San Francisco ( UCSF) Good Manufacturing Practice (GMP) facility located in the Mission Center Building in San Francisco. The current position will initially be in a highly dynamic research lab, later in a cGMP facility, with the primary focus on studying the basic biology of human embryonic stem cells.

Relationship

The Specialist will report to the Vice President (VP), Site Head of the Novo Nordisk Research Center Seattle, Inc (NNRCSI). Internal stakeholders include employees in R&D in Novo Nordisk A/S and employees of UCSF.



Essential Functions

  • The Specialist will be part of a team that will derive human embryonic stem cell lines, that fulfills Europe Medicines Agency (EMA) and Food and Drug Administration (FDA) Good Tissue Practice (GTP) and Good Manufacturing Practice (GMP) requirements; this position fulfills the part of documentation of the U line derivation
  • Documenting the tasks conducted in the GMP facility
  • On a daily basis the documentation will include but is not limited to: Cleaning; Environmental monitoring, ​Document temperature on refrigerators, freezers, heating cabinets etc., Batch record(s), Receiving raw materials
  • The Specialist will contribute to the daily routines, including maintenance of equipment, clean lab space, etc.
  • Occasional bench work required

Physical Requirements

0-10% overnight travel required.



Qualifications
  • Bachelor’s degree required in the life sciences field. Master’s degree preferred
  • A minimum of 5 years of experience with GTP and/or GMP or other systems where documentation is essential
  • A minimum of 5 years of experience with human tissue, samples or others
  • hESC and/or mammalian cell growth experience preferred
  • Knowledge of and proficiency in aseptic/regulated environment technique
  • Knowledge of registration of test results
  • Computer proficiency including MS Office, Photoshop, Endnote, photomicrography
  • Ability to work independently and in teams consisting of members with different degrees of knowledge or ability
  • Fine motor skills
  • Good oral and written communication skills in English
  • Good organizational skills

Novo Nordisk is an Equal Opportunity Employer - M/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: 59653BR
State/Provinces: Fremont
Job Category: Research


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

Job Segment: Special Medicine, Diabetes, Quality, Operations, Healthcare, Research