LEO Pharma

Senior Analytical Scientist/stability Scientist with project management skills

Are you passionate about improving lives of millions of people by supporting all our marketed products?

This is your chance to join one of the world’s leading companies within dermatology and to set your mark on the quality of life for millions of patients around the world. Global Research and Development in LEO Pharma devotes its efforts to develop innovative drugs for the treatment of skin diseases like psoriasis and eczema. You can look forward to become part of a team with high professional standards in an informal atmosphere where tasks vary and no days are alike.

 

Great opportunity within stability and analytical support and within project management

LEO Pharma is dedicated to bring new treatment solutions within dermatology to patients and we aim at developing more user friendly solutions for patients applying topical drug products.
The Pharmaceutical Product Support Area is a part of Global R&D, counting 40 persons divided into three departments. We provide fast, efficient and qualified pharmaceutical, and analytical support documentation for all marketed products at LEO Pharma.

 

Department information:

You will join 14 enthusiastic and dedicated colleagues in the Stability & Analytical Document department in Pharmaceutical Product Support. Our focus is on LEO Pharma marketed products, and we provide support for stability studies, analytical and chemical trouble shooting and documentation. You will be product responsible for a minor portfolio of products in close collaboration with colleagues from department and key stakeholder areas. Our values are courage, trust and mutual respect and helpfulness – and we care about each other. As a support area, Pharmaceutical Product Support receives a large number of unforeseen and urgent enquiries, and you must therefore be able to juggle a number of tasks and work on several projects at the same time.

 

Primary areas of responsibility:

You will be part of the department responsible for the set-up and evaluation of stability studies, analytical support, OOS and OOT resolution, support during Health Authorities inspections and maintenance of regulatory documentation. You will also be project manager for various smaller and larger projects where your great stakeholder management skills will come into play.
As a part of your daily tasks you will be expected to perform:

  • stability evaluation of marketed products
  • write and update quality documentation for regulatory purposes in connection with maintenance, projects, questions from authorities, renewals and applications for variations
  • manage and participate in projects across the LEO organization in Denmark, Ireland and France
  • Leading and participating in solving different analytical or production issues by identifying root cause and implement corrective actions on OOS and OOT so the production can continue to release products to the markets. 
  • to plan and execute analytical development and support
  • to prepare analytical validations and investigations 
  • Leading improvement projects, cross functional projects 

 

The ideal candidate:

The ideal candidate is a team player with strong collaboration skills, outgoing, tolerant and open-minded. You have a can-do attitude and are responsible, flexible, and a competent decision-maker.

 

Your experience and competences:

  • Master of Science in Pharmacy, Engineering or Chemistry
  • You are capable of analyzing and reducing complex issues and you are a person who thrives in significantly improving, changing or adapting existing processes, systems or products 
  • You have documented experience from leading projects or being cross functional project manager and have excellent stakeholder management skills 
  • Minimum of 5 years of experience within analytical chemistry and stability testing, strong CMC understanding, including insight in development, validation and implementation of HPLC methods and relevant statistical tools
  • Good communication skills (English and Danish/Scandinavian) 
  • A solid experience with GMP will be considered an advantage as we work in accordance with current GMP regulations
  • Experience with regulatory requirements, pharmacopoeias and guidelines 
  • Preferably LEAN experience or experience with continuous improvements

 

Further information?

Please do not hesitate to contact Senior Manager Birgitte Wenzell Olesen, +45 2566 4117 if you want to know more about the position.
We look forward to receiving your application. Deadline is 12th of August 2018.

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Region:

  • Region Hovedstaden
  • Region Sjælland

Job type:

Permanent

Working hours:

Full-time

Application deadline:

12/08/2018

Location:

Ballerup, Copenhagen

Company homepage:

http://www.leopharma.com

Office address: