Drug Product Development Scientist

Do you have what it takes to break new land and develop injectable biopharmaceutical products during clinical development? Are you eager to act in a team linking research and production during clinical development and documentation of formulations and processes for new injectable products? If yes, then apply now! The position As our new Scientist, you will have the responsibility for product and process development to secure optimal pharmaceutical characteristics and stability. The open position is in the late phase development where the primary focus is development and manufacture of Drug Product for phase 3 clinical trials to market. The variety of tasks covers all related aspects of product development and related fields. With your achieved knowledge, you will therefore become a key person to secure continuous progress with our stakeholders. Your responsibilities will include:

Working in close collaboration with a project team, and be responsible for designing, interpreting, and reporting studies on drug products

Writing documentation for internal and external use including clinical trial applications and patent applications

Interacting with a wide variety of internal and external stakeholders, e.g., Production facilities, Device, Primary Pack, Regulatory Affairs, Quality Assurance and Analytical Development

Together with our colleagues, you will also contribute to the on-going optimisation of processes and systems with LEAN as the guiding principle. Qualifications You hold a M.Sc. or PhD within Pharmacy, Chemistry, Biophysics, Engineering of related field of study. In addition, our ideal candidate has the below qualifications:

Experience in either formulation development, aseptic manufacturing process development, pharmaceutical production, or other relevant area within pharmaceutical drug products

Experience with documentation including regulatory and quality aspects of pharmaceutical drug products

Ability to promote collaboration with other parts of the organisation as the position requires close interaction with a variety of stakeholders

Possess strong communication skills both verbally and written in English

We are looking for someone who can show drive and have a positive can-do mind-set, you enjoy working in a team with highly motivated people dedicated to developing the next generation of pharmaceuticals. At the same time, you should work systematically and can adhere to strict documentation and quality standards. You have excellent collaborative skills, and flexibility is a natural part of your approach to interact with colleagues in the department and with your stakeholders. About the department As part of [xxxxx] PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world. We develop, manufacture and distribute drug candidates for clinical trials and have a strong culture with a “can do” mind-set. Injectable Formulation Development is part of CMC Development. We are responsible for developing drug product formulations and production processes for injectables of new biopharmaceutical products. In our daily work we link research to pilot production and drive the entire variety of injectable projects from early stage (phase 1-2) to late-stage development (phase 3-MAA). The development projects in the department include e.g. GLP-1’s, insulins, monoclonal antibodies, and RNAi. Working at [xxxxx] [xxxxx] is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. [xxxxx] relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact For further information, please contact Associate Manager Christina Haack at +[xxxxx]. Deadline 16 June 2024 You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] 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.