About the Department
At Novo Nordisk Research Center Seattle, Inc. (NNRCSI) our scientists apply cutting-edge technologies to early R&D projects with the goal of bringing real change to People with Diabetes and Obesity. Your skills, dedication and ambition will help change lives for the better and you will work with extraordinary talent, continuously learn and develop, and drive changes to defeat serious chronic conditions. We recognize the importance of an enjoyable workplace, which stimulates a strong culture of ingenuity and innovation and our support of a healthy work-life balance adds to a best-in-class employee experience. As a new focus area, we aim to build up a dynamic computational team, which will leverage structure-based design, computational biology and machine learning expertise to the drug discovery process. Our aim is to strengthen target identification and drug design processes at NNRCSI and through global collaboration across our R&D sites. This team will implement state-of-the-art structural modelling and machine learning technologies to improve functional and biophysical properties of proteins, peptides and new molecular format for future therapies. They will build up bioinformatics expertise spanning areas from sequence analysis, computer vision and different omics and pathway analysis. This team will work in a flexible, cross-functional setting in close collaboration with experimentalists to drive pre-clinical projects with very ambitious scientific goals. They will have external collaborations with academic and biotech partners within computational drug discovery in North America. We are changing lives for a living. Are you ready to make a difference?
Multiple positions available. Senior levels II and III may be considered commensurate with experience. This position will perform a variety of procedures in a manufacturing environment in compliance with Current Good Manufacturing Practice (cGMP) regulations to manufacture cell therapy products for use in human clinical trials.
The Cell Culture Associate will work at the Stem Cell manufacture facility located in Fremont, California. The Cell Culture Associate will report to a member of the Stem Cell Manufacture Leadership Team. Internal stakeholders include employees in Research and Development (R&D) in Novo Nordisk A/S, employees of University of California, San Francisco (UCSF), and employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality.
- Work with team to produce cell therapy products using undifferentiated human embryonic stem cells in accordance with the manufacturing procedures, Standard Operating Procedures (SOPs), and approved protocols in a full GTP and GMP compliant cleanroom environment including full aseptic gowning
- Assist in writing and/or revising master production records, SOPs, Deviations, change requests, training materials, protocols, reports, and other required documentation
- Provide support for commissioning and validation activities in addition to other facility start-up activities, as needed
- Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices are followed
- Troubleshoot technical process and equipment problems
- May collaborate with cross-functional teams i.e., Quality, Facilities, Process Development, and Analysis
- Perform final derivation
- Perform additional job-related duties as required
Ability to sit or stand for long periods of time, and ability to lift 25-30 lbs. Ability to work in a cleanroom environment in full aseptic gowning (no skin exposed). Ability to work flexible hours as necessitated by the process.
- Bachelor’s degree required (a degree within the life sciences field is preferred); advanced degree may be substituted for experience as appropriate
- 2+ years’ hands on experience within cell culture and/or within cell line derivation is required
- Experience with analytical procedures to assess the quality of cells (karyotyping, FACS, RNA, ICC) or cell metabolism (metabolite profiling) is preferred
- Proven aseptic technique experience preferred
- Experience writing investigation, deviations, change control documentation, standard operating procedures and other cGMP documentation
- Ability to identify, challenge, and implement potential improvements to work procedures preferred
- Highly motivated and 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
- Good oral and written communication skills in English
Novo Nordisk is an Equal Opportunity Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.
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.