Senior Principal Scientist - Parenteral ExM MS&T
9 Tage altAngaben zum Job
| Firma | Albedis Personalvermittler |
| Kategorie | Forschung / Wissenschaft | Pensum | 100% |
| Lohn (geschätzt) | CHF 88'000 – 112'000 / Jahr |
| Einsatzort | Boudry |
Job-Inhalt
- Serve as the primary technical lead for external Contract Manufacturing Organizations (CMOs) producing sterile injectable products.
- Lead technology transfer, process validation, and commercial manufacturing activities across global manufacturing sites.
- Ensure process robustness, product quality, regulatory compliance, and continuity of supply throughout the product lifecycle.
- Drive technical investigations, root cause analysis, CAPAs, and change control activities.
- Monitor process performance using data analysis and continuous process verification to identify improvement opportunities.
- Collaborate closely with Quality, Supply Chain, Procurement, Product Development, Regulatory Affairs, and external manufacturing partners.
- Lead cross-functional technical projects and support regulatory inspections and CMC documentation.
- Promote Operational Excellence (OpEx) initiatives to improve manufacturing efficiency and process reliability.
- Provide technical leadership, mentoring, and guidance to junior MS&T scientists.
- Travel to CMO sites as required to support technology transfers and manufacturing activities.
- Bachelor's degree in Engineering or Life Sciences (Master's or PhD preferred) with solid experience in sterile pharmaceutical manufacturing.
- Proven expertise in technology transfer, process validation, commercial manufacturing, and cGMP regulations.
- Strong project management, technical problem-solving, and risk assessment skills (FMEA, Ishikawa, CAPA).
- Experience working with CMOs and leading cross-functional, international teams.
- Proficiency in statistical data analysis tools (Minitab/JMP) and Quality by Design (QbD)/DoE methodologies.
- Excellent communication, stakeholder management, and influencing skills in a global environment.
- Willingness to travel internationally (10–20%) with occasional temporary on-site assignments at CMO facilities.