Senior Scientist
4 weeks ago
The position
As a member of the team consisting of 16 colleagues focusing on stability and specifications, you will collaborate closely with peers responsible for production, process, Quality Control, Quality Assurance, and Regulatory Affairs areas. Your role will be pivotal in driving collaboration within an ever-changing environment, addressing various stakeholder concerns as well as quality and regulatory-related matters for the drug product.Simultaneously, within the Specification and Stability team, you will bear responsibility for in-house oral drug products from phase 2, with the oversight transitioning to Product Life Cycle Management one year after market approval.Your primary tasks will be to:• Establish a specification strategy evaluation for late phase projects. • Create, update, and review internal drug product specification & justification of specifications. • Perform data analysis and calculations on stability data to establish specification limits.• Write external specifications and justifications for specification for clinical trial applications (CTA) and marketing authorization applications (MAA).• Document the product quality of oral drug products. Here, you will have the opportunity to shoulder significant responsibility while receiving ample support for personal and professional development. Notably, you will experience and contribute to our positive and agile mindset, embracing change and adjustment to enhance processes and meet future quality demands. Qualifications We are looking for someone that has good drug product understanding and a strong quality mindset.As a minimum, we expect that you have the following qualifications:• You hold a master’s degree within Life Sciences (e.g. pharmaceutical sciences) or similar.• At least 5 years of experience within pharmaceutical industry.• Experience with drug product development or drug product production.• You possess good communication skills in both oral and written English and preferable also Danish. Additionally, having experience in one or more of the following topics would be highly advantageous:• Oral formulation development and tablet production.• Setting drug product specifications & make justification of specifications.• Authoring regulatory application documents. As a person, you maintain high standards of quality while ensuring timely completion of tasks and approaching subsequent assignments with energy and enthusiasm. You actively contribute as a team player, displaying an open-minded, engaged attitude that inspires and motivates colleagues. Additionally, you possess excellent stakeholder management skills. About the department Emerging Technologies (ET) Product Development & Launch employs approximately 75 highly skilled and motivated employees with the mission to bring products from late development to market production. This includes development and optimization of the processes and products, creating the stability documentation as well as building up the documentation for the authorities for new products.The department consists of four teams: three process development teams and a stability and specification team. Here, we currently have open positions in our stability and specification team within the department Product Development & Launch. The purpose of the department is to bring new oral products from late phase development to market.What we do is an important part of Novo Nordisk, and as an agile department, we solve exciting and challenging tasks every day. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We are a dynamic company in an even more dynamic industry, and we know that what got us to where we are today, is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.-
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