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 Department of Genome Engineering is a dynamic, technology driven department, part of Cell Therapy R&D, a Transformational Research Unit (TRU) within Novo Nordisk. The TRU is unique in the sense that it covers the full R&D value chain, which means we function as an integrated unit, spanning from early research to GMP manufacturing and clinical development in the same organisation. Our department is part of the Platform Technologies organization based in Måløv, Denmark and we are experts in stem cell culture, genome editing, differentiation, characterization, and both in vitro and in vivo functional assessment. The Position We are looking for an experienced Platform Specialist in Cell Line Engineering to be a key stakeholder to the Global Project Lead of our Hypoimmune Project. The platform specialist will support the development of a best-in-class stem cell engineering pipeline at our GMP manufacturing facility. You will sit in our Platform Technologies (PT) area, facilitating interactions between PT and CMC manufacturing including tech transfer to GMP manufacturing. As a subject matter expert, you will be expected to input into the optimization and development of the platform strategy, mitigating critical process tradeoffs that come with execution of development strategy in a GMP setting. These activities will play a crucial role in supplying the Cell Therapy R&D unit pipeline with cutting-edge next-generation cell therapies. These therapies include genome-modified hypoimmunogenic allogeneic cell therapy products designed for the treatment of type 1 diabetes, chronic heart failure, and Parkinson’s disease, positioning us at the forefront of innovation in these therapeutic areas. Relationships The Specialist is an individual contributor and will work at the Cell Therapy R&D facility located in Fremont, Ca. The Specialist will sit within Platform Technologies, reporting to the head of the Genome Engineering Department, based in Denmark. Internal stakeholders include Cell Therapy in Novo Nordisk A/S (Denmark), and Novo Nordisk Quality. You will furthermore foster relationships with external partners. Essential Functions + As subject-matter-expert, promote agile, rapidly iterative, highly collaborative approaches to drive ambitious timelines and ensure smooth transition from process development into production + Identify and troubleshoot technical issues with the process and equipment. Develop and implement corrective actions including novel molecular designs, assays and/or cell delivery technologies to increase quality, efficacy, and throughput of editing pipeline. + Clearly communicate results to stakeholders including project team members and project governance forums. Contribute to data-driven recommendations and analyses for strategic decisions including “develop vs. outsource" based on project priorities and technology strategies. + Drive innovation by integrating internal and external expertise, incorporating the latest technologies, and leading digital programs aligned with CTO CGT strategies. + Partner with leaders from across Cell Therapy R&D to explore, adapt and develop novel CT technologies/platforms aligned with the vision of advancing highly engineered cell therapies for T1D, PD and CH + Contribute towards creation of technical standards for gene editing, with a emphasis on cell fitness and with consideration of established quality systems. + Apply bioinformatic and gene editing protein functional knowledge to improve genome editing methods and processes. Scout novel GE technologies that may support project goals by actively engaging the external scientific community. + Mentor and develop scientific leaders and junior scientists, fostering a culture of scientific rigor, collaboration, and innovation + Write and/or revise SOPs, training materials, protocols, reports, and other required documentation + Train staff in new processing method + Perform additional job-related duties as required Qualifications + PhD or Master's degree in Ph.D. in Cellular & Molecular Biology, Biotechnology, Genetics, Biochemistry or a related field highly preferred; Bachelor 's Degree required + Doctoral degree in with 6+ years’ post-doctoral and/or industry relevant experience + Master’s degree with 12+ years’ relevant experience + Bachelor's degree with 18+ years’ relevant experience can be considered + Relevant required experience includes: + Extensive experience in gene editing and development including application of biological methods such as gene sequencing, clone screening, transfection/electroporation of RNPs and subclone strategies + Experience with analytical procedures to assess the quality of cells (PCR/qPCR/ddPCR, genetic stability, CNV, FACS, Karyotyping) + Experience developing quality control metrics is preferred + Experience within stem cell culture. Hands-on experience within cell line derivation technical procedures and aseptic conduct and technique. + Experience in nonviral delivery strategies is preferred. + Experience in cell therapy manufacturing, including process design, scale-up, and optimization. + 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, including the ability to create and deliver compelling presentations The base compensation range for this position is $150,000 to $190,000. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors. 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. 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. 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.