Specialist - Cell Therapy Manufacturing

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Job description

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 in cell therapy which raises hopes for improved treatment of Type 1 Diabetes and other chronic diseases.

The Specialist will provide technical expertise and perform various tasks in a manufacturing environment in compliance with cGMP regulations. The Specialist will help in the development of new processes, organize and coordinate manufacturing activities, and train junior and newly hired personnel.

Relationships

The Specialist is an individual contributor and will work at the Cell Therapy R&D facility located in Fremont, Ca. The Specialist will report to a member of the Cell Therapy Leadership Team. Internal stakeholders include Cell Therapy in Novo Nordisk A/S (Denmark), 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
• Train staff in processing methods, aseptic technique, and cGMP clean room operations
• Write and/or revise master production records, SOPs, deviations, change requests, training materials, protocols, reports, and other required documentation
• Identify and troubleshoot technical issues with the process and equipment. Develop and implement corrective actions
• 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
• 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
• Collaborate with cross-functional teams i.e., Quality, Facilities, Process Development
• Perform final derivation
• 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 of normal working hours as required to process the cells.

Qualifications

• Education Level: Associates degree required; Bachelors degree in a life sciences field preferred
• Experience Level: BS with 6+ years or AS with 8+ years of experience of relevant experience. Advanced degree may be substituted for experience as appropriate
• Specific or technical job skills:
  • Experience within cell culture. Hands-on experience within cell line derivation technical procedures, mammalian cells, derivation, and/or knowledge in GMP/GTP, aseptic handling is preferred. Knowledge of aseptic conduct and technique is preferred
  • Aseptic technique and be capable of training individuals in aseptic technique
  • Experience writing investigations, deviations, change control documentation, standard operating procedures and other cGMP documentation is required
  • Demonstrated drive and at ease working in a results-driven dynamic research and development environment
• Experience with analytical procedures to assess the quality of cells (karyotyping, FACS, RNA, ICC) or cell metabolism (metabolite profiling) is preferred
• Demonstrated ability to identify, challenge, and implement potential improvements to work procedures
• 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
• Managerial experience (if applicable): N/A

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.

This position is part of a job family. Title and level within the job family are evaluated based on a number of factors, such as years of experience, scope of work, proficiency, and business need. Candidates will be assessed for the most appropriate title and level within the job family during the recruitment process. The base range of pay for each title open to consideration in this job family are as follows:

• Specialist- $100,000 to $111K
• Sr. Specialist - $110K - $126K

In addition, this position is eligible for a company bonus based on individual and company performance.

Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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