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BRIAN PERRELLA
CHERYL PEDOTA
Prabhdeep Singh
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Validation Technical Scientist Job

Date: Apr 19, 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.

PURPOSE:

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 Validation Technical Scientist will be responsible for validation activities within the facility and responsible for planning, organizing and supervising all qualification activities and ensure it is carried out within the framework of established cGMP policies, procedures and guidelines.

RELATIONSHIPS:

The Validation Technical Scientist will work at the CMC Stem Cell Manufacturing facility located in Fremont, Ca. The current position will initially be in a highly dynamic qualification team, later in a cGMP facility, with the primary focus on studying the basic biology of human embryonic stem cells. The Validation Technical Scientist will report to the Senior Director of CMC Stem Cell Manufacturing. Internal stakeholders include employees in R&D in Novo Nordisk A/S, employees of UCSF, and employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality. External stakeholders include vendors and service providers.


ESSENTIAL FUNCTIONS:
  • Responsible for overseeing all validation activities at the facility
  • Specify design and perform qualification of equipment and facilities used for the manufacture of stem cells
  • Process qualification of critical supporting processes for example HVAC, CIP, PW, WFI, PQ, N2
  • Investigate and trouble shoot validation problems for equipment and/or performance processes
  • Delegate to and scientifically support the technicians and other scientist in their project work, including trouble-shooting of technical and validation issues
  • Plans, organizes, supervises and evaluates work assigned to contractors; develops, implements and monitors work plans to achieve assigned goals and consistent with quality and service expectations.
  • Plans, organizes, supervises, evaluates and participates in providing varied facilities and equipment maintenance and repair services; reviews and prioritizes assigned work orders; reviews work requirements and assignments; monitors and inspects completion of work; oversees projects with associated contractors for qualification of equipment and processes.
  • Responsible for complying with the requirements related to own job functions
  • Performs special projects as assigned
PHYSICAL REQUIREMENTS:
  • Approximately 20% overnight travel.
  • Ability to work flexible hours as necessitated by the process
QUALIFICATIONS:
  • Bachelor's degree required with a minimum of 8 years relevant experience or a Master’s degree with a minimum of 6 years relevant experience or PH.D. with a minimum of 3 years post-doctoral experience.
  • 4 years of experience within qualification/validation of process equipment in a GMP regulated environment are required
  • Basic methods and practices used in the maintenance, repair and operations are required
  • Advanced troubleshooting techniques within the assigned areas of responsibility
  • Experience with principles and practices of GMP documents is required
  • Ability and desire to support the team with additional tasks







Requisition ID: 59667BR
State/Provinces: Fremont
Job Category: Research


Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

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