Analytical Project Leader

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 Position

The perfect candidate for this Analytical Project Leader role is a highly experienced chemist with a Ph.D. or Masters degree and a minimum of three years in small molecule drug development. They must be an expert in HPLC/UPLC and ICH-compliant method validation capable of independently managing stability studies impurity profiling and regulatory documentation (IND/NDA). Beyond technical prowess they are a proactive leader who seamlessly coordinates between internal labs and external partners while maintaining a strict cGMP and quality-focused mindset.

The Opportunity:

• Developing a phase-appropriate control strategy for drug substances and drug products.

• Collaborating effectively with stakeholders across various departments.

• 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.

Who you are:

• A Masters or Ph.D. in chemistry pharmacy or a related field with at least three years of professional experience in analytical development of drug substances or drug products for small molecules

• In-depth knowledge of chemistry including synthesis purification and characterization

• Expertise in key analytical techniques such as High-Performance Liquid Chromatography (HPLC) Ultra-Performance Liquid Chromatography (UPLC)

• Proven experience in developing and validating ICH-compliant analytical methods

• Proficiency in degradation and stability studies for small molecules including forced degradation and impurity profiling

• Understanding of key requirements for drug substances and drug product specifications

• Fluent in English; German proficiency preferred

• A strong quality mindset and excellent attention to detail

• Digital savviness to support digital transformation initiatives; familiarity with statistical analysis of analytical data is also advantageous

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.