Posted to MedZilla on 6/15/2019

Novo Nordisk

US-CA, Cell Culture Lead Associate Job 545054400A2-MZ


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 decease and chronical heart failure.

The Position

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.


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

  • Organize, coordinate and lead production activities and ensure execution of processes in production while strictly adhering to cGMP regulations, environmental health and safety guidelines, and any other related regulations which could apply
  • 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
  • Write and/or revise 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
  • Train staff in processing methods, aseptic technique and cGMP clean room operations
  • Review batch production records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices are followed
  • Troubleshoot technical process and equipment problems
  • Collaborate with cross-functional teams i.e., Quality, Facilities, Process Development, and Analysis
  • Perform final derivation
  • Perform additional job-related duties as required

Physical Requirements

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 (degree in the life sciences field preferred); advanced degree in the life sciences field may be substituted for experience as appropriate
  • 6+ years’ experience within cell culture. Hands-on experience within cell line derivation development, mammalian cell culture, derivation, and aseptic handling is required
  • Experience with analytical procedures to assess the quality of cells (karyotyping, FACS, RNA, ICC) or cell metabolism (metabolite profiling) is preferred
  • Experience writing investigation, deviations, change control documentation, standard operating procedures and other cGMP documentation
  • Demonstrated ability to identify, challenge, and implement potential improvements to work procedures
  • 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.

Requisition ID: 59662BR
State/Provinces: Fremont
Job Category: Research

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