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Process Development Associate - Cell Therapy

Facility:  Research
Location: 

Fremont, CA, US

About the Department                                                                                                                                     

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 dedicating efforts to drive stem cell therapies forward. Stem cell-based therapies raise hopes for improved treatment of diseases where an individual’s cells are damaged or non-functional, including Type 1 Diabetes, Parkinson’s disease and chronic heart failure. This team will work with stem cell lines generated by Novo Nordisk and help develop processes to generate functional cells for treatment of such diseases.


 

 

The Position

This position will work on technology transfer and process development efforts in support of the 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. Potential for international travel. 


Novo Nordisk requires all employees, both Field and Office-based, to be fully vaccinated with a COVID-19 vaccine prior to the first date of employment. As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment

 

Qualifications

  • High School Diploma required, Bachelors degree highly preferred 
  • A minimum of 6+ years of relevant experience is required. Advanced degree may be substituted for experience as appropriate
  • 6+ years of relevant experience includes
    • Experience with aseptic technique (academic or industry setting) 
    • Experience with maintaining a laboratory notebook and doing basic experimental troubleshooting 
    • Experience with mammalian cell culture required. Stem cell experience preferred.
  • Experience in cell-based therapy technology transfer and/or development is preferred.
  • Experience working in a cross collaborative environment 
  • 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

 

The base compensation range for this position is $59,230 to $109,049. The actual base compensation offer is based on a number of a factors. 

 

Millions rely on us 
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further. 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.

 

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.