Description
We are looking for a
Commercialization Packaging & Device expert (NOVJP) (m/f)
Reference: -en
Start: 02/18
Duration: 6 MM++
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Provide technical expertise from commercial point of view during device development stages and process commercialization
- Support Launch Site Decisions at e.g. PAC (Post Approval Commitment) by providing analysis of technology, capacity, skills by performing interfunctional evaluations
- Manage technical launch activities (process, technology, capacity, resources) for assembly and packaging at involved sites
- Assure that all activities are performed according to current processes and standards (GMP, HSE, Regualtory)
- Ensure PAI (Pre-Approval Inspection) readiness
- Act as a manufacturing representative during device development stages (design control)
- Act as a manufacturing representative in the packaging design process for the BTDM product portfolio
Your qualifications
- Education (minimum/desirable): PhD, Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology
- Fluent in English and local language (German) an advantage
- Extensive experience in Pharmaceutical Manufacturing (preferably assembly & packaging) / Manufacturing Science and Technology / technical Development in assembly & secondary packaging projects
- Thorough understanding of product processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
- Knowledge in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications)
Skills:
- Project manager