Research Associate - Clinical Formulation - Cell Therapy

About the Department                                                                                                                                             

In Cell Therapy Research and Development, we are focused on developing cellular medicines that have the potential to change the way doctors treat intractable diseases.  We manufacture targeted cell types derived from pluripotent stem cells using precisely controlled expansion and differentiation processes.  Therapeutic areas of current focus include cardiomyocytes to treat heart failure, beta cells for diabetes, dopaminergic neurons for Parkinson’s disease and multiple cell types for dry age-related macular degeneration. 
Join a dynamic, innovative and interdisciplinary team focused on developing the medical devices and combination products that enable preparation and delivery of these novel cell products.  We develop micro and macro fluidic formulation and cell product handling devices, as well as a broad range of administration applications including devices for stereotactic brain delivery, beating heart delivery, general surgical implantation, etc.

The Position

We are actively searching for an experienced Research Associate to join our Clinical Formulation Development team in Cell Therapy R&D, located in Fremont, California. The ideal candidate will have a strong background in pharmaceutical formulation and/or cell and tissue biology, and a passion for utilizing their skills in the development of life-changing treatments. We are open to hiring at the Sr. RA or Associate Scientist level commensurate with experience.  As a Research Associate, you will play a crucial role in the development of formulations for the storage, transportation, and clinical delivery of CELL THERAPY drug products. This hands-on position will involve aseptically handling cells or cell aggregates, performing analytical assays, collecting and analyzing data, and authoring and executing experimental protocols with documentation in electronic lab notebooks.  In addition to these responsibilities, you will have the opportunity to work with advanced imaging techniques and media analysis to support the design, evaluation, and qualification of safe and effective cell product formulations and devices used to deliver doses of cellular medicines to patients. We are looking for a passionate and dedicated individual who is eager to contribute their skills and expertise to a dynamic and collaborative team.

Relationships

Reports to a leader in the Clinical Formulation Development team. Interacts with key company personnel both within and outside of Novo Nordisk as related to product development programs. Develops and maintains positive rapport and working relationships with other personnel in combination product development, medical devices, Cell Therapy R&D, and other partner departments within Novo Nordisk in support of initiatives and to accomplish company goals.

Essential Functions

• Design and execute experiments to investigate and identify cellular product formulations enabling storage, transportation, or dose delivery of CELL THERAPY drug products
• Conduct analytical assays including aggregate size distribution, cell viability, apoptosis, hormone secretion, and functional evaluation
• Aseptically handle cells or cell aggregates (e.g., media exchange, centrifugation, and washing) and maintain cell culture as needed
• Perform data analysis and interpretation and draw main conclusions to present at group and cross-functional team meetings
• Make detailed observations and document experimental methods and results in an electronic lab notebook (ELN)
• Troubleshoot independently or with supplier as necessary
• Provide input for product specifications, design inputs, design outputs, and other Quality Management System documents within the context of cellular combination product systems
• Effectively communicate complex scientific or technical concepts to engineering and non-technical cross-functional colleagues
• Author and execute test protocols, perform analyses, and write reports. 

Physical Requirements

Up to 10% overnight travel required.

Qualifications

• Bachelor's degree required, preferably within the discipline of biomedical engineering, bioengineering, chemical engineering, mechanical engineering, or life sciences. Master’s degree with no industry or post graduate experience can be considered. 
• At least 2 years’ relevant experience required with a bachelor’s degree.
• Relevant experience includes some combination of: 
  • Aseptic cell handling or processing
  • Analytical procedures to assess the viability and functionality of cells and tissues
  • Medium formulation
  • Chemical and physiochemical characterization (e.g., rheometry, osmometry, pH)
  • Extracellular matrix or hydrogel encapsulation
  • Mammalian cell culture, 3D spheroid or organoid culture systems, and cryopreservation
• Preferred experience includes:
  • Cell and/or gene therapy drug product development (e.g., formulation, cryopreservation, fill and finish, stability, in-use compatibility, etc.)
  • Development and assessment of biologic/device combination products
  • Knowledge of cell interactions with formulations (media) and medical devices (materials, physical environment)
  • Knowledge of pancreatic islet biology and physiology or islet transplantation
  • Demonstrated ability to work independently and in teams
  • Self-motivated, strong scientific curiosity, detail oriented, a continuous drive to learn new skills and techniques
  • Excellent verbal and written communication skills

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. The base compensation range for this position is $65,850 to $115,240. Base compensation is determined based on a number of factors. 

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.