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Associate - Process Development

About the Department                                                                                                                                 

Imagine transforming the face of biomedical research, helping patients getting healthier with digital therapeutics, and advanced medical devices in a state-of-the-art research facility. That’s what we do at Novo Nordisk Research Center Seattle, Inc. (NNRCSI). Our scientists and engineers apply cutting-edge technologies to early R&D projects with the goal of bringing real change to People with Diabetes and Obesity. Such projects include applying data science when developing advanced medical devices and digital decision support solutions. At 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 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 and obesity 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 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 Position

Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes to 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 (T1D). T1D 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. 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. This team will work with new stem cell lines generated by Novo Nordisk that will be used to generate functional cells for therapies to treat Type 1 Diabetes, Parkinson's disease and chronic heart failure. This position will work on technology transfer and process development efforts in support of device development and manufacturing of stem cell derived products for use in human clinical trials.

 

Relationships

The Process Development Associate will work at the Chemistry, Manufacturing and Control (CMC) Stem Cell Manufacture facility located in Fremont, California. The Process Development Associate will report to a member of the Stem Cell CMC and Manufacture management team. Internal stakeholders include employees in Research and CMC in Novo Nordisk Headquarters in Denmark; employees in Manufacturing, Quality Assurance, Quality Control and Analytical Development at Novo Nordisk Fremont; and employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI).

 

Essential Functions

  • Perform process development experiments using undifferentiated and differentiated human embryonic stem cells: including, but not limited to, preparation of cell culture raw materials, monitoring, routine cell culture, sample processing, biomaterial handling, product stability studies, and packaging / transport validation studies
  • Work closely with colleagues in Måløv, Denmark to transfer and develop processing methods
  • Perform manufacturing development studies to enable technology transfer of scalable processes
  • Support manufacturing staff in processing methods
  • Support laboratory operations and logistics
  • Generate, manage, evaluate, and maintain complete and accurate laboratory documentation and critical data in electronic files in a highly organized manner
  • Operate and troubleshoot cell culture equipment
  • Draft and review technical documents (protocols, technical reports, summaries, process investigations, Standard Operating Procedures (SOPs) and batch records)
  • Collaborate with cross-functional teams i.e., Quality, Analytical, Production
  • Provide support for commissioning and validation activities in addition to other facility start-up activities, as needed
  • Provide support for production of cell therapy products using undifferentiated human embryonic stem cells in accordance with the manufacturing procedures, SOPs, and approved protocols in a full GTP and GMP compliant cleanroom environment including full aseptic gowning, as needed

 

Physical Requirements

10-20% overnight travel required.

 

Qualifications

  • High School Diploma, a minimum of 8 years relevant experience is required. With a BS/BA, 2 years minimum relevant technical experience is required; Associate or Vocational degree plus 4 years minimum relevant experience. Advanced degree may be substituted for experience as appropriate.
  • Relevant required experience includes:
    • Experience with aseptic technique and mammalian cell culture
    • A proven record of strong laboratory and critical thinking skills
  • Preferred experience includes:
    • ​​​​​​​Experience in cell-based therapy technology transfer and/or development is preferred
    • Experience with stem cells strongly preferred
  • Must be team-oriented with a positive attitude
  • Excellent communication abilities (verbal, written, interpersonal) required
  • Must have excellent time management and organizational skills (schedules, timelines, task prioritization), with the ability to adapt to changing priorities
  • Must be self-motivated and solution oriented with excellent multi-tasking and problem-solving skills
  • Must be comfortable working in a results-oriented dynamic research and development environment
  • Ability to work independently and in teams consisting of members with different degrees of knowledge or ability required

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

 

Novo Nordisk requires all new hires to be fully vaccinated against COVID-19 prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation.

 

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.

Associate - Process Development

Fremont, CA
Traveling

Published on 08/31/2022

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