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Upstream Pilot Scientist

2 months ago

Gentofte, Denmark Novo Nordisk AS Full time

Are you excited to work with Pilot scale development in new Pilot facilities? Do you want to work with the development of complex processes and be part of a super engaged team? Then you might be our new colleague in Active Pharmaceutical Ingredients (API) Manufacturing Development Upstream Pilot Plant.

The position

As Upstream Pilot Scientist you will work with many different tasks within development and production of cultivation processes in Pilot scale, and you will have a key role in securing our responsibility for the delivery of data and products.

Your main responsibilities will be focused on:

Yield- and process optimizations including down-scaled experiments in our in-house laboratory. Creating and keeping central documents as Master Formulas and In-process Controls updated. Specialized support to the ongoing activities in the pilot facilities. Transfer of processes from development to pilot facilities. Implementation of new equipment and technology.

Furthermore, you are expected to build and maintain a good relation to a wide range of stakeholders like the QA, research & development (R&D), project managers, analytical departments and project groups.

We work as a team, and you will therefore have a broad variety of assignments and great opportunities for further developing your skills. Team spirit is important to us and although we like working independently, we believe in succeeding together.

Qualifications

We imagine that:

You hold a MSc in Biotechnology, Chemistry, Biology, or of similar relevance. Preferably, you have 2+ years of experience working with cultivation/fermentation Ideally you have experience from a pharmaceutical production and experience with LEAN and cGMP. You are fluent in English.

On a personal level, you are outgoing and self-driven – you thrive in an environment where you get to challenge yourself, always seizing an opportunity for personal and professional development. You take pride in identifying opportunities for optimizations, while consistently maintaining delivery focus. You have a strong collaborative mindset and a pragmatic approach to challenges, including bringing people together to find solutions.

About the department

API Manufacturing Development Process Support in Gentofte is part of API Manufacturing Development, and we consist of app. 98 employees organized in 7 teams.

You will become part of the team "Upstream Pilot Plant" consisting of 3 Pilot Scientist, 7 Pilot Technicians and 2 Pilot Engineers (SAP and PAS-X). The team’s primary responsibility is the entire set of Life-Cycle-Management activities for all BRD’s API’s and Support Proteins. This ranges from Development work for Phase 3 production, regulatory strategy and submissions, innovation (testing and implementing new technologies) and laboratory experiments for e.g. yield optimization.