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For an important international pharmaceutical company based in Neauchâtel area, we are looking for a
Senior Principal Scientist - Parenteral ExM MS&T H/F - 100%
Temporary 6 month assignment
Description du poste
- 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.
Profil attendu
- 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.
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