Description
We are looking for a
Senior drug product lead in late phase biopharmaceutical development (NOVJP) (m/f)
Reference: -en
Start: 03/18
Duration: 12 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- 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
Your qualifications
- 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)
- 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
Skills:
- Product manager