Prabhdeep Singh

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Lead Cell Culture Associate Job

Date: Jun 20, 2019

Location: Fremont, CA, US

Company: Novo Nordisk

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 Cell Culture Lead Associate will work at the Stem Cell manufacture facility located in Fremont, California. The Cell Culture Lead 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 University of California, San Francisco (UCSF), and employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality.

The Position
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.

Essential Functions
  • Develop and implement production plans for the manufacturing team in order to meet project objectives
  • 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
  • Provide technical mentorship, scientific guidance to junior staff, and peer leadership
  • Routinely generate, implement, and communicate new ideas and/or new applications for existing manufacturing approaches
  • Work independently; exercises discretion and judgment on a variety of complex projects related to production and commissioning and validation activities
  • 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 Good Manufacturing Practice (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
  • Participate in 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
  • Collaborate with cross-functional teams i.e., Quality, Facilities, Process Development, Analysis and members of project teams. Contribute to documentation and updates to management
  • 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 (degree in the life sciences field preferred) with 8+ years of experience within cell culture is required; advanced degree may be substituted for experience as appropriate
  • Hands-on experience with cell culture, derivation, and aseptic handling is required
  • Experience with analytical procedures to assess the quality of cells (karyotyping, Fluorescence-activated cell sorting (FACS), RNA, ICC) or cell metabolism (metabolite profiling) is preferred
  • Experience writing investigation, deviations, change control documentation, standard operating procedures and other cGMP documentation is required
  • 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: 60061BR
State/Provinces: Fremont
Job Category: Research

Nearest Major Market: San Francisco
Nearest Secondary Market: Oakland

Job Segment: Biology, Medical Lab, Cell Biology, Special Medicine, Science, Healthcare, Research