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The Position

PTT (MSAT & Engineering) is responsible for ensuring that PT 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 PTT Roches global Manufacturing Science and Technology (gMSAT) department is the process and product owner for commercial products encompassing internal and external drug substance and drug product sites new technology implementation network standardization and mitigation of technical risks. The gMSAT team is structured with product-focused Large Molecule and Synthetic Molecule (Drug Substance & Drug Product) Technology and Network Standards and Operations (Process Stewards Tech Deployment and Pilot Plant) teams operating in cross-functional squads and circles.

The Principal Analytical Control System Lead is the deep subject matter expert (SME) and end-to-end (E2E) technical owner for the Analytical Control System supporting commercial synthetic molecules (starting materials intermediates drug substances excipients and drug products) manufactured at Roche sites and Contract Development and Manufacturing Organizations (CDMOs). You take ownership for the end-to-end Lifecycle Management process of Analytical Control Systems in synthetic molecules (DS & DP) and provide matrix leadership for all synthetic molecules analytical topics in gMSAT while also acting as the single-point-of-contact for relevant stakeholders beyond PTT.

The Opportunity

This role is a central component of the strategy to consolidate analytical responsibilities reduce fragmentation and create a single accountable owner for analytical control systems post-launch. Your main responsibilities are:

• Driving the technical industrialization and sustaining the technical product health (TPH) of commercial products by ensuring that analytical methods and control systems are validated reliable and compliant throughout the product lifecycle.

• Delivering on the products analytical technical strategic roadmap which includes:

• Providing E2E analytical control system ownership across the entire commercial SM portfolio.

• Leading the transfer and validation of analytical procedures at commercial CDMOs (the formal handover point of ownership from Technical Development PTDC-A to Global MSAT).

• Integrating drug substance (DS) and drug product (DP) analytical controls under a single accountable leader to ensure chemistry manufacturing and analytical control evolve in tandem.

• Acting as the primary analytical control system owner for product teams (e.g. PTT TDT) site teams (e.g. JMT) quality functions (e.g. external QA local QC) and key technical governance forums.

Who you are

You have supported both Drug Substance and Drug Product analytical activities for commercial products ideally at CDMOs and you bring the following qualifications:

• a B.S. or M.S. degree in a scientific discipline (chemistry pharmacy engineering or a related technical field in synthetic molecules). A PhD is an advantage.

• 10 years of relevant industrial experience in analytical method development validation or Quality Control (QC) support for Drug Substance (DS) or Drug Product (DP) manufacturing. Recognized as an authority in pharmaceutical analytical control strategy.

• In-depth conceptual and practical knowledge of the Analytical Procedure Lifecycle (ICH Q2 Q14) and its application to synthetic molecules including definition of the analytical target profile (ATP) impurity characterization and control strategy.

• Demonstrated experience with ICH Q8 and ICH M4 expectations ensuring regulatory submissions and the control strategy are aligned with the overall Manufacturing Process.

• Significant cross-functional matrix leadership experience.

Ready for the next step We look forward to hearing from you. Apply now to discover this exciting opportunity!

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.