Cell Culture Associate I

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

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, Parkinsons disease and chronical heart failure.

** open to hiring at Cell Culture Associate II/III commensurate with experience **

This position will perform a variety of procedures in a manufacturing environment in compliance with cGMP regulations to manufacture cell therapy products for use in human clinical trials.

Relationships

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 R&D in Novo Nordisk A/S, employees of UCSF, and employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality.

Essential Functions

• Write and/or revise master production records, SOPs, Deviations, change requests, training materials, protocols, reports, and other required documentation
• Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices are followed
• Provide support for commissioning and validation activities in addition to other facility start-up activities, as needed
• Assist as needed in training staff in processing methods, aseptic technique and cGMP clean room operations
• Conduct gene editing on selected cells
• May collaborate with cross-functional teams i.e., Quality, Facilities, Process Development, and Analysis
• Perform additional job-related duties as required
• Troubleshoot technical process and equipment problems
• Produce 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
• Load and operate automated liquid handling equipment
• Perform final derivation
• Assist with organizing and coordinating production activities

Physical Requirements

0-10% overnight travel required. Ability to stand or sit for long periods of time. Ability to do repetitive work, requiring strong dexterity and hand/eye coordination. Ability to lift up to 25 lbs.

Qualifications

• Preferred experience includes:
  • Hands-on experience within cell line derivation development, in vitro fertilization associated technical procedures, mammalian cells, derivation, and or knowledge in GMP/GTP, aseptic handling is preferred
  • Experience in gene editing
  • Experience with analytical procedures to assess the quality of cells (karyotyping, FACS, RNA, ICC) or cell metabolism (metabolite profiling)
  • Experience writing investigation, deviations, change control documentation, standard operating procedures and other cGMP documentation
• Proven aseptic technique experience
• 2+ years’ relevant experience required:
  • Hands on experience with cell culture
  • Proven aseptic technique experience
• Hands-on experience within cell line derivation development, in vitro fertilization associated technical procedures, mammalian cells, derivation, and or knowledge in GMP/GTP, aseptic handling is preferred
• Experience writing investigation, deviations, change control documentation, standard operating procedures and other cGMP documentation
• Bachelor’s degree in the life sciences field is required; advanced degree may be substituted for experience as appropriate
• Experience with analytical procedures to assess the quality of cells (karyotyping, FACS, RNA, ICC) or cell metabolism (metabolite profiling)
• Hands on experience with cell culture
• Ability to work independently and in teams consisting of members with different degrees of knowledge or ability
• Experience in gene editing
• Ability to identify, challenge, and implement potential improvements to work procedures preferred
• Good oral and written communication skills in English
• Highly motivated and comfortable working in a results-oriented dynamic research and development environment

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 $141,170. Base compensation is determined based on a number of factors.

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.