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Specialist in Analytical Development

 
Requistion ID:  355
Location: 

Copenhagen, N/A, DK

Date:  May 08, 2019
 

Specialist in Analytical Development (AD)

 

Description
We are looking for an experienced academic who will provide scientific and project management leadership for analytical development activities.

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 22 engaged and competent employees (10 academics, 9 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, KF, XRPD, particle size measurement and dissolution, and we are working with CMO partners for some of our projects.

Your job and key responsibilities 

You will be responsible for the analytical development in our global development projects and coordinate the CMC analytical input for clinical studies. You use your experience within API analyses to drive the discussions and internal procedures covering fate and purge of API impurities, and the corresponding regulatory documentation. 

You will be an active member of the CMC focus team(s), and your responsibilities include:

  • Analytical development, validation, release and stability studies, covering both API and drug product for the given project
  • Ensuring flexible planning and coordination of analytical projects tasks in close collaboration with colleagues across the organization and with CRO/CMO’s
  • Scientific leadership for analytical development related to API production and processes, including input for fate and purge of impurities
  • Responsibility for documentation both for internal and regulatory purposes, including review of analytical regulatory documents

 

Qualifications 

Our preferred candidate has the following personal and professional qualifications: 

  • You hold a PhD within analytical chemistry, chemistry, pharmaceutical science, or another relevant scientific discipline
  • You have several years of relevant experience and proven scientific skills within analytical development and project management 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 API synthesis development, and in-depth experience with the corresponding analytical documentation
  • You have several years of experience in building the analytical documentation package for regulatory filing
  • 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 Director of Analytical Development, Christine Weber on CHW@lundbeck.com. Your application and CV should not be sent via email.

We also recommend that you have a look at our website.

 

Your application

Please click on the link below to apply for the job. Applications must be received no later than May 27th, 2019.

 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.


An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.