Job Description

Bei Roche kannst du ganz du selbst sein und wirst fur deine einzigartigen Qualitaten geschatzt. Unsere Kultur fordert personlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du fur das, was du bist, wertgeschatzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl personlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat - heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zahlt.


Die 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, Roche's 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 product's 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!


Wer wir sind
Eine gesundere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat - heute und fur zukunftige Generationen. Durch unser Engagement werden uber 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgefuhrt. Wir ermutigen uns gegenseitig, neue Moglichkeiten zu erkunden, Kreativitat zu fordern und hohe Ziele zu setzen, um lebensverandernde Gesundheitslosungen zu liefern.


Gemeinsam konnen wir eine gesundere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fordert.