QA Academic CMC Development

2 days ago

København, Denmark Lundbeck AS, H Full time

This is a great chance to work as a QA Academic, working with quality assurance in CMC. We provide a role collaborating with multiple stakeholders and with various responsibilities in your daily work supporting CMC deliverables from early to late phase pipeline projects.

Your new role – why is this a great opportunity?

You will join a growing department with a bright future ahead as it supports our current pipeline and expected acquisitions of new drug candidates. As our new colleague, you will support the progression of our pipeline of promising drug candidates as QA for GMP manufacturing activities of API including the related QC activities.

In the job, you will assure quality and approve documentation related to Small Molecule API manufacturing and QC activities such as: API master batch records, batch records for GMP produced materials, specifications, and qualifications. You will release raw materials, starting materials, intermediates, API including QA approval of deviations, change controls, and laboratory deviations. You will contribute to our continued development of the Quality Management System by authoring and approving SOPs governing the activities.

You will join a great team working closely together while balancing workload. This position allows you to enhance your skillset and understanding in CMC development tasks and increase your responsibilities as you advance in the role.

Your future team

The CMC Development QA organization consists of approximately 20 employees based in Copenhagen, Seattle, US, and La Jolla, US who together are responsible for efficient and compliant quality processes in support of the development of Small Molecule- and Biologics drug candidates – including device activities.

You will join a QA Department located in Valby, Copenhagen and will be working primarily in DK time zone. You will support our internal API manufacturing in Lumsås, Sjællands Odde, and must therefore be in commuting distance of Lundbeck Headquarter in Copenhagen with the possibility to visit our site in Lumsås, Sjællands Odde 1-3 times monthly.

You will be part of a collaborative team, where the culture is characterized by a curious and faithful approach in a friendly and organized working environment.

We offer an opportunity for you to enhance your experiences and professional development.

What you bring to the team

  • You hold a master’s degree in either Pharmacy, Chemistry, Engineering, or similar.
  • You are interested in pharmaceutical development and production, and skilled in organic and analytical chemistry.
  • Understanding of GMP requirements and interpretation of regulatory requirements.
  • 2-5 years of experience within working in a GMP environment.
  • You are fluent in both Danish and English.

Our promise to you

Lundbeck offers an inspiring workplace, passionate colleagues and a culture characterized as collaborative – a must to successfully bring our treatments through research and development all the way to commercialization and the people who need them. We offer a mix of exciting tasks and numerous development opportunities that are balanced with initiatives focused on your well-being.

Apply now

Do you envision yourself in this role? We want to hear from you. Upload your CV and include a few lines about your motivation for applying. No separate cover letter is needed. We ask you not to include a photo or personal information that does not relate to your professional experience.

If you have questions or want to hear more, please feel free to contact Senior Director CMC Development QA – Charlotte Ullits Houlbjerg via phone +45 30 83 21 69. Applications must be received by February 03, 2025. Application review and interviews will be conducted on an ongoing basis. The position might be unposted before the deadline as we find the best candidate.

We need every brain in the game – and that includes all brains and the different perspectives we bring to the table. At Lundbeck, we embrace the uniqueness of each employee, and we are committed to building a workforce that is as diverse as the people we serve.

#J-18808-Ljbffr

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