About the Department
Imagine transforming the face of biomedical research and building world-class protein technology platforms in a state-of-the art facility. That’s what we do at Novo Nordisk Research Center Seattle, Inc. (NNRCSI). Our scientists apply cutting-edge technologies to early discovery projects within the diabetes and obesity areas, with the goal of bringing molecules to market. Such projects include identifying protein-based therapies for obesity, diabetes, and adjacent therapeutic areas, and researching the next generation of medical devices. At the NNRCSI, your skills, dedication and ambition will help us change lives for the better. In exchange, we’ll offer you an opportunity to work with extraordinary talent, continuously learn and develop, and drive change to defeat diabetes and other serious chronic conditions.
The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop in their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package, generous benefits, and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. Are you ready to make a difference?
The Environmental Monitoring (EM) Associate will work at the Stem Cell manufacture facility located in Fremont, California. The Cell Culture Associate 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.
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.
- Conduct viable and non-viable testing in the Good Manufacturing Practice (GMP cleanroom including the manufacturing suite and surrounding shared areas
- Complete and archive documentation utilizing Good Documentation Practices
- Write and/or revise master EM records, standard operating procedures (SOPs), training materials, protocols, reports, and other required documentation
- Review EM records for completeness, accuracy, and to ensure Current Good Manufacturing Practice (cGMPs) and Good Documentation Practices are followed
- Provide support for commissioning and validation activities in addition to other facility start-up activities, as needed
- Order, stock, and inventory supplies for the EM program and other areas
- Coordinate EM testing results with an outside laboratory and UCSF employees
- Assist in conducting investigations for EM excursions including determining root cause and developing corrective and preventative actions
- 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
0-10% overnight travel required.
- Associates degree in the life sciences field is required
- 2+ years of 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
- Knowledge and experience with aseptic conduct and technique preferred
- Experience and ability to work in sterile cleanroom gowning required
- Knowledge of current Good Manufacturing Practices
- Familiarity with regulatory requirements for environmental monitoring of cleanroom areas
- Ability to recognize problems and recommend solutions to problems based on technical understanding of testing techniques
- Good organizational and communication skills
- Ability and desire to support the team with additional tasks
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. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
Requisition ID: 60235BR
State/Provinces: San Francisco
Job Category: Research
About Novo Nordisk
At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions.
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.
Our company culture
The Novo Nordisk Way – who we are, where we want to go and how we work.
Each and every employee is responsible for acting in accordance with the Novo Nordisk Way – and to help each other understand what it means in practice.
A passion for helping people
The story of Novo Nordisk goes back more than 90 years
It began when August Krogh, a Nobel Prize-winning professor at the University of Copenhagen, decided he wanted to start producing a revolutionary new medical preparation called insulin.