Proclinical is seeking a Senior MSAT Specialist (Analytical Development) for a biopharma role focused on ensuring timely delivery of end-to-end analytical activities related to oral solid dose products.
This includes method development, validation, transfer, statistical analysis, and data visualization in alignment with global regulatory guidelines.
The role involves close collaboration with cross-functional teams and establishing strong technical relationships with Contract Manufacturing Organizations (CMOs) worldwide.Responsibilities:Author and review documentation related to analytical method development, validation, and transfer.Ensure compliance with regulatory requirements for products and raw materials.Collaborate with R&D teams and external partners to ensure analytical methods are suitable for production.Troubleshoot and optimize analytical processes to improve product quality and efficiency.Lead effective investigations.Coordinate with regulatory affairs teams to prepare and submit analytical sections for regulatory filings.Lead analytical projects, coordinate timelines, and ensure deliverables are met.Assess the urgency and importance of different tasks and projects.Provide guidance and mentorship to other team members.Apply statistical methods to analyze analytical data and ensure robustness.Create clear and informative visual representations of analytical results.Coordinate activities with contract research organizations (CROs) or external testing facilities.Key Skills and Requirements:Degree in natural science or similar field.Experience in oral solid dose (OSD) product development and manufacture phases.Understanding of regulatory dossier requirements.Project management and technical leadership skills.Ability to lead cross-functional groups and work as a team member.Knowledge of quality by design and technology transfer.Experience with method development and interpretation of analytical data.Strong leadership and ability to build technical relationships.Working understanding of pharmaceutical quality regulations (cGMP).Proficiency in data interpretation and statistical analysis.Professional level of English; understanding of French is beneficial.