Associate - Analytical / Process Development

Facility:  Research
Location: 

Fremont, CA, US

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

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 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, and Quality Control at Novo Nordisk Fremont; and employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI).

 

Essential Functions

  • Execute existing assay SOPs to support method and process development studies
  • As needed, support process development experiments using undifferentiated and differentiated human embryonic stem cells
  • Work closely with colleagues in Måløv, Denmark to support tranfer of analytical or process 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, Production

 

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
    • Experience with executing assays, such as flow cytometry and PCR
    • A proven record of strong laboratory and critical thinking skills
  • Preferred experience includes:
    • Experience in cell-based analytical method technology transfer and/or development
    • Experience with stem cells
  • 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.