Department: BPD, Bioprocess Development
To develop our growing pipeline of products we are looking for an experienced professional in the area of Late Phase Biologics Pharmaceutical Development. As a member of the team, you will play a key role in the development of formulation and processes for parenteral dosage forms for proteins for late phase clinical or commercial use. You will also be strongly involved in the generation of registration documents.
- 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.
• PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline with excellent theoretical and scientific knowledge.
• Excellent English required (oral & written); good skills in German as site (local) language desired (oral)
• At least 5-10 years 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.
• Demonstrated successful experience with working in interdisciplinary teams, track record of creativity, problem solving and productivity in projects