- Stein, Aargau, Switzerland
- On-site
- Director
Take ownership of critical customer programs and play a pivotal role in bringing innovative products to market, leading technology transfers, commercial launches and lifecycle management activities within a state-of-the-art Drug Product fill & finish manufacturing facilities.
Responsibilities
- Lead high-value and high-complexity Drug Product technology transfer and product lifecycle programs, driving the end-to-end journey from clinical development through process validation (PPQ), regulatory submission, commercialization, CPV/OPV and lifecycle management.
- Act as the senior technical authority for complex customer programs, defining commercialization and validation strategies, providing technical governance, and serving as the escalation point for critical manufacturing, process and compliance challenges.
- Lead the transfer, scale-up and implementation of Drug Product manufacturing processes into GMP operations, ensuring manufacturing readiness, successful commercial launch and sustainable routine production performance.
- Develop and oversee Stage 1, Stage 2 and Stage 3 Process Validation strategies, including risk assessments, PPQ execution, statistical evaluations, trend analysis, process monitoring and post-approval change assessments.
- Partner closely with customers and cross-functional stakeholders across Manufacturing, MSAT, QA, QC, Regulatory Affairs and Supply Chain to deliver program milestones, support regulatory submissions, and ensure inspection readiness for PAI and GMP audits.