API Lead – coordinate process development and manufacturing activities

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Ballerup

Would you like to contribute to the building of a small molecule pipeline and do you want to be part of an open informal and welcoming environment.

Do you have a solid track record within coordination/project management across pharma manufacturing and API, and are you looking for a place, where your efforts will really make a difference, then this could be the opportunity you have been waiting for.

LEO Pharma has embarked on a very ambitious journey to become the world’s preferred dermatology care partner, and that is why we need you. You will enter LEO Pharma at the most exciting period. Right now, Chemical Development is focusing on building a small molecule pipeline, and by joining our team as our coordination expert number one you will be able to make your mark on turning this into new successes.

Make the work of three teams and external partners come together

You will join a department of approx. 30 Scientists and Technicians split into 3 teams; an analytical expert team (Center of Excellence), a pilot plant team and a process research & development team. Your job is to coordinate activities across all teams and external partners. You key task will be:

  • Coordinating process development and manufacturing activities
  • Managing outsourced chemical development activities to CROs/CMOs including selection of contractual aspects
  • Compiling and/or review relevant project documents, regulatory and quality (including product specific QbD documents) documentation
  • Coordinating project activities with a range of internal stakeholders
  • Managing our overall project plan, report and presenting results to the CMC team
  • Managing project budget
  • Coordinating transfer of drug candidates from Medicinal Chemistry to Chemical Development
  • Coordinating the transfer of API process to MSAT/GPS organization responsible for commercial manufacturing
  • Assume responsibility for observing that all relevant regulations and guidelines are adapted and followed

You will be working from LEO Pharma’s HQ (and biggest manufacturing site) in Ballerup Copenhagen.

Natural science degree backed by solid API and coordination experience
Your background in the pharma industry has provided you with a well-equipped toolbox that enables you to effectively coordinate and drive activities in a natural science environment dealing with people from different professional and cultural backgrounds.

About you:

In our world “one size fits all” does not exist, you must be able to tailor your communication to your audience. You understand what it means to take ownership, and you take pride in maintaining the overview – working in a structured manner. Being part of an organization in transformation it is pivotal that you thrive in an environment where the only constant is change. Additionally, your CV comprises:

  • Minimum M.Sc. in chemical, and/or pharmaceutical sciences
  • 10+ years’ experience in the pharma industry including 5 years’ experience in API development
  • Proven project coordination/management skills with both internal and external stakeholders
  • Motivation for working within GXP
  • Very good English skills, written and spoken

About Chemical Development:

We have the vision in place, and we believe we have found the right balance between in-house ownership/manufacturing and use of external research and manufacturing partners. Our environment is characterized by collaboration, knowledge sharing and a common drive for creating tangible results.

Contact and application

If you have questions, please do not hesitate to contact Fabrizio Badalassi, Director API R&D, +45 3160 2913, [email protected]. . The deadline is 17th October 2021

We look forward to receiving your application.


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Ballerup.

Jobbet er oprettet på vores service den 27.9.2021, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Ballerup
  • Søndag den 17. oktober 2021

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