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

REFERENZNUMMER:

377573/29

IHRE AUFGABEN:

-Lead and co-ordinate the drug product team (functional experts) and represent Pharmaceutical Development on the CMC subteam. Fulfill all tasks and responsibilities related to own discipline
-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.)
-Actively support generation of international registration documents for market authorization and interact with authorities where appropriate; act as technical expert in audits or inspections
-Contribute to overall development strategies and improvement of operational excellence of business processes
-Contribute to evaluation of new scientific technologies/equipment and proactively identify and realize opportunities for Invention Disclosures
-Represent pharmaceutical development in external collaborations
-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)
-Profound 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
-Demonstrated successful experience with working in interdisciplinary teams, track record of creativity, problem solving and productivity in projects

WEITERE QUALIFIKATIONEN:

R&D scientist