Description
We are looking for a
Subject Matter Expert in drug product development (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- In this role you will be responsible to support the tech transfer of manufacturing process of biologics drug product to the commercial manufacturing site
- Contribute to the failure mode and effects analysis (FMEA) and other technical documents to support the tech transfer
- As the subject matter expert for DP development, you will represent DP in the in technical CMC teams of the assigned project
- You will work closely with your colleagues in pharmaceutical operations, device development, analytics and quality
- Contribute to optimization of scientific/technical activities in assigned projects, network and/or platforms
- Contribute to optimization of processes within the own area of responsibilities
- Proactively support generation of registration documents and interact with authorities where appropriate
Your qualifications
- PhD or equivalent education in Pharmaceutical Technology, Biochemistry, Chemistry, Chemical Engineering or a related discipline
- Excellent English required (oral & written); good skills in German as site(local) language desired (oral)
- Adequate experience on process risk analysis, management, and mitigation is desired
- Experience with technical transfer and scale up for lyophilisates is highly desired
- A profound experience in the pharmaceutical development of biologics (formulation & manufacturing process), preferably in late phase development
Skills:
- Project assistant