Senior drug Product Lead in late Phase Biopharmaceutical Development (NOVJP00025561) (m/f)

REFERENZNUMMER:

363501/11

IHRE AUFGABEN:

-Lead and co-ordinate the drug product team (functional experts) and represent Pharmaceutical Development on the CMC sub team
-Design, plan, perform and monitor all assigned drug product development activities applying state of the art technologies
-Meet quality, quantity and timelines in all assigned projects
-Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)
-Interpret results, evaluate data, draw relevant conclusions, and write reports
-Generate scientific documents to hand over to internal partners (Manufacturing sites, Device Development, RegCMC, Clinics etc.)
-Coach junior team members

IHRE QUALIFIKATIONEN:

-PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline with excellent theoretical and scientific knowledge
-Excellent English required (oralgood skills in German as site (local) language desired (oral)
-Relevant experience in pharmaceutical industry, including thorough understanding of late phase pharmaceutical development activities for Biologics and/or process engineering of sterile dosage forms as well as a generally broad scientific and strategic background
-Thorough track record of process transfer, validation and – importantly - regulatory submissions including health authority inspections
-In-depth background in commercial manufacturing and/or technical life cycle management of Biologics drug products is of advantage

WEITERE QUALIFIKATIONEN:

Product manager