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PTT (MSAT & Engineering) is responsible for ensuring that PT (Pharma Technical Operations) stays at the forefront of technology in our facilities and supports our robust processes & efficient operations. We focus on integrating product health, process health with equipment fit for purpose, and facility readiness in support of the manufacturing network.
Within Global MSAT Synthetic Molecules, we are seeking a highly skilled and motivated Senior Analytical Steward to oversee and drive Analytical Science & Technology (ASAT) activities. In this role, you take responsibility for the transfer of analytical methods to our CDMO network, enabling industrialization and reliable commercial manufacturing.
You play a key role in strengthening analytical science and technology standards and ensuring robust control strategies for testing of starting materials, intermediates, and drug substances manufactured by our partners for Roche.
Ensure industrialization readiness and regulatory compliance of analytical methods with ICH Q2, ICH Q8, and ICH Q14. Ensure analytical control strategies are aligned with the overall manufacturing strategy
Own the entire analytical method transfer to a CDMO for product launch and commercial manufacturing. Ensure effective knowledge transfer and technical alignment with partner sites
Support implementation of analytical operations at the CDMO QC laboratories (e.g., equipment alignment, method optimization, troubleshooting). Provide technical oversight during start-up and routine operations
Oversee validation activities at the CDMO, including the definition of requirements, setting of testing parameters, and assessment of method performance. Ensure validation strategies meet regulatory expectations
Author and review technical reports, validation documents, and regulatory submissions to enable efficient industrialization and lifecycle management. Ensure alignment with ICH M4 and regulatory submission requirements
Contribute to cross-site and cross-functional teams responsible for technical oversight of analytical operations across the network
Serve as a subject matter expert in analytical procedure lifecycle management.
Within Global MSAT, you are joining a collaborative and science-driven environment, with opportunities to shape analytical control strategy across our commercial manufacturing network and engage in impactful projects that strengthen product quality and ensure reliable supply to patients worldwide. You bring the following qualifications:
An advanced degree in a scientific discipline (chemistry, pharmacy, or a related technical field in synthetic molecules; a PhD is an advantage) with 7+ years of relevant industry experience in analytical method development, validations, or quality control supporting drug substance manufacturing
In-depth conceptual and practical knowledge of the Analytical Procedure Lifecycle (ICH Q2 and ICH Q14), including Analytical Target Profile (ATP) definition, impurity characterization, and control strategy development
Solid understanding of ICH Q8 and ICH M4 requirements, ensuring regulatory submissions are aligned with the manufacturing and control strategies
Strong collaboration and communication skills, with the ability to work effectively across functions and sites, and a proactive, structured mindset with a strong focus on quality, compliance, and reliability
Travel to CDMO manufacturing sites may be required (<10%), and occasional work outside standard business hours may be required to accommodate international collaborations
Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!
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.