Quality Control Associate Scientist

About the Department

Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes 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. Type 1 Diabetes 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. It is usually diagnosed in children and young adults. 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. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson’s and chronical heart failure. Are you ready to make a difference?

The Position

The purpose of the Quality Control Associate Scientist role is to ensure timely analysis of cell-based products and raw materials in order to support production schedules and customer requirements. The QC Associate Scientist will provide guidance and mentor more junior staff as well as coordinate cross-functionally with other teams and organizations as needed. They will perform testing as needed to support products and development activities, as well as assist with validation and qualification activities. They will maintain QC equipment in a validated state, including coordinating calibration and maintenance activities as needed.

Relationships

The Quality Control Associate Scientist will work at the CMC Stem Cell Manufacture facility located in Fremont, CA. This position will report to a member of the Stem Cell Manufacture Leadership Team. Internal stakeholders include employees in Process Development, Manufacturing, Quality Assurance, Quality Control and Analytical Development at NN Fremont, employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Corporate office in Denmark. This position does not have any direct reports but is expected to be able to manage projects and other tasks assigned to them.

Essential Functions

• Test incoming raw materials, in-process samples and final products per written and approved Test Procedures and SOPs. Testing methods will include but are not limited to multi-color flow cytometry, PCR, ELISA, other immunological assays, cell growth and viability analysis, and morphology evaluation
• Setup, record and manage data in LIMS, and PEMS in accordance with written and approved SOPs
• Establish and maintain laboratory and equipment in accordance with written and approved SOPs
• Test stability samples at defined time points
• Establish processes for maintaining the quality control lab and responsible for sample tracking
• Generate reports for environmental monitoring, including reviewing and analysis of trend data
• Execution of method verification and qualification protocols, performing data analysis and writing the subsequent verification and qualification reports
• Ensures data integrity. Conducts data collection, accurately interprets experimental data and formulates conclusions, and may communicate data externally. Ensures proper documentation of experimental data; may contribute to milestone/project documentation
• Maintain supplies and reagents inventories, and order as needed
• Coordinate sampling and testing with contract test labs and other locations as needed
• Write and/or revise SOPs, protocols, reports, and other required documentation
• Mentor and train QC associates and technicians
• Additionally, this position will support other tasks that ensure success of the organization as needed

Physical Requirements

Ability to work flexible hours as necessitated by the process.

Qualifications

• Bachelor’s Degree required, within Biology/Chemistry/Life Sciences or related field preferred
• 8 years’ relevant experience required (or 4 or more years with an advanced degree). Preferred within the Pharmaceutical/Biotech industry. Relevant experience is defined below:
  • Experience writing standard operating procedures, specifications and other cGMP documentation required
  • Experience with the application of cGMPs, USP/NF, EuPH., FDA guidelines and ICH guidelines with the pharmaceutical industry is required
  • Experience writing investigation, deviation and change control documentation is required
  • Experience Training Technicians and Associates
  • Experience with molecular biology, immunology and cell culture
  • Experience with multi-color flow cytometric analysis, including a functional understanding of FMO’s, ISOTYPE controls, and compensation
  • Experience with ELISA assays, cell culture techniques

• Ability to understand, apply, and evaluate basic biology and scientific principles as appropriate for the position
• Demonstrates a breadth of knowledge and skills to independently support development and clinical manufacturing
• Working knowledge of LIM’s preferred
• Excellent organizational and multi-tasking skills, attention to detail, and the ability to adapt to changing priorities
• Ability to identify and elevate issues and identify solutions
• Ability to work on fast-paced, collaborative teams and demonstrate flexibility in response to changing priorities is a must
• Computer literacy including fluency with Microsoft Word, Excel, Teams Outlook
• Strong organizational, trouble-shooting, communication and interpersonal skills are essential

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.