Pharmaceutical Scientist with Expertise in APIs and Excipients

1 month ago

Måløv, Denmark Novo Nordisk AS - A1p Full time

The position In this job, you will participate in the transfer of new products from R&D to the production sites in Denmark, EU, and the United States, with a special focus on the characteristics of APIs/excipients and their impact on the performance and robustness of the tablet production. As we expand our product portfolio and our production sites, we are also expanding our use of APIs and pharmaceutical excipients and its suppliers; we, therefore, expect you to participate in the ongoing implementation of new grades and types of APIs/excipients. This includes testing the APIs/excipients on a lab-scale and in full-scale production equipment and setting requirements for specifications towards suppliers. Furthermore, you will be involved in the development of test strategies and development of small-scale powder characterization methods to measure, e.g., powder flow and compaction properties, to increase our knowledge about our APIs/excipients and their impact on the drug product process and quality. You will contribute to:• Evaluation of new grades and types of APIs and pharmaceutical excipients.• Life cycle management with focus on APIs and pharmaceutical excipients for tablet production.• Development and implementation of state-of-the art powder characterization to improve tablet production processes.• Project management by leading projects and tasks across the organization.• Update of internal and external documents with requirements, specifications, and justifications,• Problem-solving in relation to process and quality challenges. When necessary, you will be driving root cause analysis and trouble-shooting sessions in cooperation with the production and analytical departments among other important stakeholders. Qualifications To master this role, you will need to combine your process and drug product understanding with a good quality mindset for the finished product. You will also have to build relations with your colleagues in the Production, Quality Control, Quality Assurance and Regulatory Affairs areas.As a minimum, we expect that you have the following qualifications:• A master’s degree and/or a PhD in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, or a similar field.• Experience with unit operations for tablet production - obtained either through your education or work experience.• Good Manufacturing Practice (GMP) knowledge.• Fluent in English. It will, furthermore, be a huge advantage if you have experience with one or more of the following topics:• Minimum 2 years of experience from the pharmaceutical industry or academia, e.g., product development, support, transfer, or process validation. • Experience with project management.• Experience with handling of change requests and deviations from a GMP regulated production.• Previous experience with APIs/excipients for oral formulation and tablet production.• Danish proficiency.On a personal level, you possess great collaboration skills, are structured, have a natural sense of priority and not afraid of setting the direction and make tough decisions. Ultimately, you see yourself as a team-player who enjoys cross-functional, cross-departmental and stakeholder collaboration. 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. 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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