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The Analytical Research & Development department, an integral component of Synthetic Molecules Technical Development, bears global responsibility for the advancement of cutting-edge analytical methodologies, the comprehensive analysis of raw materials, intermediates, active pharmaceutical ingredients, and diverse dosage forms pertaining to synthetic molecule development products, and the meticulous preparation of regulatory documentation for submission to health authorities.
In this role you will be joining a highly motivated and experienced team of analytical scientists. You will be responsible for leading analytical development activities for synthetic molecule projects, from early development to commercialization. This is an exciting opportunity to apply your expertise in a dynamic and challenging environment, contributing to the development of life-changing medicines.
Developing a phase-appropriate control strategy for pharmaceutical dosage forms, encompassing the active ingredient and its precursors.
Collaborating effectively with stakeholders across various departments, including drug substance and drug product process development and manufacturing, Technical Regulatory Affairs, Quality Assurance, and both internal and external analytical partners (such as service providers and commercial manufacturing/testing/packaging sites). This will occur within a Technical Development Team.
Coordinating comprehensive analytical activities, which involves generating physical and chemical data for materials, developing/improving and validating analytical test methods or other analytical controls, generating packaging-specific stability data, and ensuring thorough documentation.
Coaching technicians and junior scientists on project work and serving as a central point of contact for project-related information.
Contributing to local and global initiatives, particularly those focused on implementing new technologies, digitalization, or harmonization efforts.
A Master's or Ph.D. in chemistry, pharmacy, or a related field, accompanied by a minimum of five years of professional experience within the pharmaceutical industry.
Profound expertise in analytical development, encompassing formulation development support and the implementation of a control strategy for impurities in Investigational New Drug (IND) and New Drug Application (NDA) filings.
A robust foundation in liquid chromatography (HPLC and UHPLC) with proficiency in various detection methods, including UV, Mass Spectrometry (MS), fluorescence, and charged aerosol detection.
A comprehensive understanding of quality control principles is essential. Demonstrated experience in applying Good Manufacturing Practice (GMP) requirements and a clear understanding of their application across different clinical phases.
Digital acumen to support digital transformation initiatives; familiarity with statistical analysis of analytical data is also advantageous.
Excellent command of the English language. Proficiency in German is considered a plus.
Superior communication skills and a proven ability to collaborate successfully.
Open-minded, goal-oriented, and capable of thriving in a rapidly evolving environment.
Views challenges as opportunities and consistently demonstrates respectful collaboration with team members, customers, and stakeholders, even under pressure.
Knowledge of oligonucleotides/peptides analytical development is a plus.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
