Senior Principal Scientist - Parenteral ExM MS&T

Functieomschrijving

Description de l'entreprise

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 recherché

• 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.