Environmental Monitoring Associate II Job:
Novo Nordisk

59650BR
Novo Nordisk
Fremont California
Pharmaceutical
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Description

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

This position will perform a variety of procedures in a manufacturing environment in compliance with cGMP regulations to organize and conduct testing, create and maintain standards, and conduct investigations for the Environmental Monitoring (EM) program.

Relationship

The Environmental Monitoring (EM) Associate will work at the Stem Cell manufacturing facility located in Fremont, Ca. The Cell Culture Associate will report to a member of the Stem Cell Manufacturing Leadership Team. 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.

Essential Functions

  • Lead investigations for EM excursions including determining root cause and developing corrective and preventative actions.
  • Conduct viable and non-viable testing in the GMP cleanroom including the manufacturing suite and surrounding shared areas.
  • Write and/or revise master EM records, SOPs, training materials, protocols, reports, and other required documentation
  • Review EM records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices are followed
  • Order, stock, and inventory supplies for the EM program and other areas
  • Coordinate EM testing results with an outside laboratory and UCSF employees
  • Lead commissioning and validation activities within EM PQ and support other facility start-up activities, as needed
  • Support inspections from Authorities and internal audits
  • Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes
  • Proactively take on additional work to support the manufacturing team with all aspects of the process

Physical Requirements

  • Ability to sit or stand for long periods of time, and ability to lift 25-30 lbs
  • Ability to work in a cleanroom environment in full aseptic gowning (no skin exposed).
  • Ability to work flexible hours as necessitated by the process.
Qualifications
  • Associates degree in the life sciences field is required.
  • 4+ years' experience executing viable and non-viable sampling in a cleanroom environment using air samplers, particle counters, swabs, and contact plates. Advanced degree may be substituted for experience.
  • Experience with regulatory requirements for environmental monitoring of cleanroom areas including EM PQ activities
  • Experience and ability to work in sterile cleanroom gowning required
  • Experience with current Good Manufacturing Practices
  • Knowledge and experience with aseptic conduct and technique preferred Ability to recognize problems and recommend solutions to problems based on technical understanding of testing techniques
  • Excellent organizational and communication skills
  • Ability and desire to support the team with additional tasks


Requisition ID: 59650BR
State/Provinces: Fremont
Job Category: Research

Basic Qualifications
Requirement