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Position:                      CMC Project Manager

Reports to:                  Senior Director CMC / Regulatory Affairs

 

Client:

A Bethesda / Munich based and NASDAQ traded Drug Discovery company develops antibody based therapeutics for the treatment of cancer, autoimmune- and inflammatory diseases. With its more than 120 professionals in both sites it combines excellent science with a highly, integrated development organization. It complements inhouse competence by a network of academic and industrial partners.

Life Science professionals in all of Central Europe wish to work for this company which is located in one of the most popular areas in Europe: 45 minutes by car to Garmisch, various lakes and castles in bycycling distance. Oktoberfest almost in walking distance.

Task:

The Project Manager covers the regulatory aspects of all CMC affairs in the Process Sciences Department. Specifically, this manager:

  • Helps shaping all activities in product development and specifically in process development projects
  • Recognizes early on likely issues and searches for solutions
  • Represents the CMC function of the company as a member of the various project teams
  • Carries the responsibility for a successful and timely supply of the documents required for regulatory approval (NDA / IMPDs, MAA/BLAs). The Project Manager is being assisted by the CMC documentation team.
  • Carries the responsibility to coordinate and to assist in preparing and filing the regulatory documentation and related documents
  • Prepares scientific advisory meetings with the authorities to discuss CMC affairs
  • Reports to the Vice President Process Sciences

Profile:

  • Degree in Pharmacy, Biotechnology, Biology, Chemistry or related science
  • Solid background skills regarding CMC for biologics
  • Several years of job experience in the area of Regulatory Affairs of biopharmaceuticals and specifically CMC
  • Several years of team work within the drug discovery industry
  • Experience in managing small and effective teams
  • Solid experience in Regulatory Affairs for CMC and its documentation
  • Convincing personality, strong communication skills and good team interaction
  • Quick grasp on the issues and entrepreneurial attitude
  • Fluency in English to address the international challenges, German a nice to have
  • Experience overseas advantageous but no prerequisite

 

 

hier bewerben! please apply here

 
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