Associate - Cell Therapy Manufacturing

Associate - Cell Therapy Manufacturing

Facility: Manufacturing

Location: Fremont, CA, US

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, which 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 insulin injections and potentially offering better blood glucose control. 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 chronic heart failure. Are you ready to make a difference?

The Position

The Associate will perform a variety of tasks in a manufacturing environment in compliance with cGMP regulations. The tasks may include, but are not limited to, reagent preparation, supporting senior personnel with experiments and other lab work (cell culture, documentation, troubleshooting, etc.).

Essential Functions

• Conduct mammalian cell culture including media preparation, exchange, and cell passaging in a full GTP and GMP compliant cleanroom environment including full aseptic gowning.
• Documentation of manufacturing activities in Batch Records.
• Update Standard Operating Procedures.
• Using proper aseptic technique, conduct operations in cleanrooms ranging from Grade C to Grade A.
• Identify and troubleshoot technical issues with the process and equipment.
• Provide support for commissioning and validation activities in addition to other facility start-up activities as needed.
• Investigate and author documentation for minor deviations.
• Collaborate with cross-functional teams, e.g., Quality, Facilities, Process Development.
• Perform additional job-related duties as required.

Physical Requirements

Up to 10% overnight travel required. Ability to qualify to work in the cleanroom, up to Grade A requirements. Ability to lift 25 lbs. Ability to work outside normal working hours as required to process the cells.

Qualifications

• Education Level: Associates degree required, BS in a scientific field preferred.
• Experience Level: BS with 2+ years or AS with 4+ years of relevant experience.
• Specific or technical job skills:
• A minimum of 2 years of experience working with mammalian cells is required.
• Self-motivated and comfortable working in a dynamic research and development environment.
• Ability to work independently and within diverse teams.
• Good oral and written communication skills in English are required.
• Knowledge of aseptic conduct and technique is preferred.
• Experience writing cGMP documentation is preferred.
• Managerial experience: N/A

This position is part of a job family. Title and level within the job family are evaluated based on several factors, such as years of experience and business need. The base range of pay for this title is $85,000 to $95,000, with a company bonus based on performance. Novo Nordisk offers long-term incentive compensation, employee benefit programs, and time off policies.

Novo Nordisk is committed to creating an inclusive culture that celebrates diversity. We are an equal opportunity employer.