Analytical Project Lead
vor 2 Wochen
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The PositionThe 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.
The OpportunityAs an Analytical Project leader, your main responsibilities will include:
Developing a phase-appropriate control strategy for drug substances and its precursors.
Collaborating effectively with stakeholders across various departments, mainly drug substance process development and manufacturing.
Coordinating comprehensive analytical activities, which involves generating physical and chemical data for materials, developing/improving and validating analytical test methods or other analytical controls and ensuring thorough documentation, timely delivery and adherence to quality standards
Coaching technicians and junior scientists on project work and serving as a central point of contact for project-related information
Conduct work in compliance with cGMP where applicable, safety, and regulatory requirements.
Supervise internal laboratory activities and / or testing activities at CLOs/CDMOs
Plan and document experiments/results independently and prepare for regulatory submissions such as IND and NDA.
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 analytical development of drug substances
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.
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.
Your complete application includes your up to date CV and a motivation letter.
Who we areA 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.
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