Senior Analytical Scientist/Specialist - Analytical Development
Copenhagen, N/A, DK
Senior Analytical Scientist/Specialist – Analytical Development
Do you want to use your passion for analytical chemistry to help us in developing innovative treatments, to improve the lives of people living with brain diseases?
We are looking for an experienced analytical scientist who will be part of our Analytical Development group and work closely together with skilled colleagues from other scientific disciplines to find unique solutions in our small-molecule development projects.
Joining us, you will be part of an organization which is solely focused on development of new drug candidates for brain diseases, and you will be part of the Chemical and Pharmaceutical Research (CPR) area which is responsible for CMC development at Lundbeck.
The department Analytical Development (AD) consists of 24 engaged and competent employees (11 academics, 10 technicians and 3 assistants) working cross-organizationally on our small-molecule development projects from late discovery to product launch.
The department is responsible for physico-chemical characterization, development and validation of new analytical methods, and release and stability analyses for drug substances and drug products for clinical studies. We are working internally with a range of analytical techniques, such as HPLC, GC, LC/MS, Dissolution, KF, XRPD and particle size measurement, and we are working with CMO partners for some of our projects.
Your job and key responsibilities
You will work on our development project together with colleagues from Analytical Development and from areas like Process Chemistry and Pharmaceutical Development. In collaboration you will be responsible for progressing our development projects and you will contribute with analytical expertise to find the right solution for the individual projects.
You will be responsible for the analytical development activities and develop and execute strategy for analytical development, validation, stability studies and release for clinical studies, covering both API and drug product for the given project. This responsibility includes:
- Apply scientific knowledge and expertise to ensure we meet project milestones and solve challenges in the individual projects.
- Ensuring flexible planning and coordination of analytical projects tasks in close collaboration with colleagues across the organization and with CRO/CMO’s
- Author, review, and approve CMC documentation for regulatory filings as well as internal purposes.
Qualifications
Our preferred candidate has the following personal and professional qualifications:
- You have a Ph.D. within analytical chemistry, chemistry, pharmaceutical science or another relevant scientific discipline. Candidates with Master degrees and commensurate experience will also be considered.
- You have several years of relevant experience and proven scientific skills within analytical development in the pharmaceutical industry
- You possess drive and a positive mindset, embrace challenges, and can inspire your colleagues and the teams you work in, even when facing obstacles
- You have a good understanding of CMC development, and in-depth experience with the corresponding analytical documentation.
- You possess creative and strategic skills to solve complex scientific challenges in an environment where prerequisites and timelines change rapidly
- You are fluent in spoken and written English
Further information
For further information, please contact VP of Pharmaceutical R&D Frank Høien on fhk@lundbeck.com or +45 30832399. Your application and CV should not be sent via email.
We also recommend that you have a look at our website, LinkedIn and Instagram.
Your application
Please click on the link below to apply for the job. Applications must be received no later than 20 October 2019.