Associate Global Project Manager (m/f)

REFERENZNUMMER:

351142/11

IHRE AUFGABEN:

-Serve as a point of contact to CMOs to represent Global Biologics

Manufacturing Science and Technology on multiple projects -Provide technical expertise for commercial aseptic drug product manufacturing at CMOs
-Ensure technical leadership for commercial process transfers to CMOs
-Define and guide commercial drug product production network alignment activities and provide technical support to the Technical Product Management organization
-Definition of process validation strategy
-Technical leadership of risk management activities
-Write and/or review regulatory submissions, validation reports, quality investigation reports and change control assessment for technical content
-Identify, develop and communicate manufacturing best practices and harmonized business processes to

the commercial Biologic drug product production network

IHRE QUALIFIKATIONEN:

-Advanced degree in life sciences or engineering
-Profound experience in pharmaceutical industry, including aseptic drug, Product formulation, process development or manufacturing
-Technical experience in aseptic manufacturing of commercial biological drug products
-Skills as a project leader
-Strong quality orientation with good knowledge of cGMPs, regulatory guidelines and validation Practices
-Flexibility in work hours and travel (approx. 20%) to meet business objectives
-Very good spoken and written command of English and German

WEITERE QUALIFIKATIONEN:

Project manager, PMO - Project Management Office