MSAT Senior Scientist - Geneva

OM Pharma in Meyrin, CH, seeks a Senior Scientist in MSAT to lead pharmaceutical product development and industrialization, from formulation to validation, ensuring compliance with GxP standards and contributing to regulatory documentation.

This role focuses on advancing pharmaceutical product development from initial formulation through to full-scale manufacturing, including process optimization and technology transfer. The Senior Scientist will guide cross-functional teams in defining development strategies, managing laboratory operations, and ensuring regulatory compliance throughout the product lifecycle.

Responsibilities

• Lead the development and industrialization of new pharmaceutical products, covering formulation, process design, scale-up, and validation
• Define development strategies including QTPP, risk assessments, technical specifications, timelines, and budgets
• Provide technical expertise in galenics, formulation, pharmaceutical processes, and technology transfer, including interactions with CDMOs
• Drive improvements in existing manufacturing processes to enhance performance, robustness, and compliance
• Serve as a technical lead for troubleshooting, root cause analysis, CAPA implementation, and continuous improvement efforts
• Identify and define Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs), leading process risk assessments in cross-functional teams
• Manage MSAT Pharma Laboratory operations, including equipment qualification, stock control, and lab support
• Plan and execute development trials with internal stakeholders (Manufacturing, Quality, Validation, Regulatory CMC), ensuring thorough documentation and data analysis
• Maintain full traceability and compliance of development activities in accordance with GxP requirements
• Contribute to regulatory documentation such as CTD modules in collaboration with Regulatory CMC

Requirements

• Master’s degree in Pharmaceutical Sciences, Biotechnology, or equivalent field
• Minimum 8 years of experience in pharmaceutical process development, formulation development, and industrial transposition, with deep knowledge in galenics and pharmaceutics
• Demonstrated project management experience in cross-functional teams within a GxP environment
• Fluent in French and proficient in English
• Skilled in MS Office and ERP systems, with preference for Sage X3

Nice to have

• Experience in regulatory activities

About the company

OM Pharma is a global biopharmaceutical company headquartered in Geneva, specializing in preventing recurrent respiratory and urinary tract infections and treating vascular diseases. The company operates internationally through a network of partners and reinvests profits into R&D for microbial-derived immunotherapeutic products targeting inflammation and infection-related disorders, aiming to improve patients’ quality of life worldwide.

• Global biopharmaceutical company based in Geneva
• Leader in prevention of recurrent infections and treatment of vascular diseases
• Operates worldwide through international partners
• Reinvests profits into R&D for immunotherapeutic products
• Committed to improving patient outcomes through better treatment of immunological imbalances