Principal Analytical Steward (gMSAT Small Molecules) at Roche

Basel, Basel-City, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

14 Jul, 26

Salary

0.0

Posted On

15 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical method development, Quality control, Matrix leadership, Analytical lifecycle management, Synthetic molecules, Regulatory compliance, Drug substance, Drug product, ICH Q2, ICH Q14, ICH Q8, ICH M4, Analytical target profile, Impurity characterization, Control strategy development, CDMO management

Industry

Biotechnology Research

Description

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 Within PTT (global MSAT, Engineering & Sustainability), 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 Opportunity As the primary architect of our evolving analytical framework, you are responsible for building the new commercial Analytical Subteam structure from the ground up, ensuring it is robust, scalable, and future-ready, connecting the existing Centers of Analytics, Technical Development, and External Quality to gMSAT. Central to this mission is the implementation and execution of the new cAST (Commercial Analytical Sub Team). Your responsibilities include: Act as the primary architect of our global analytical framework, in which you provide matrix leadership to the analytical experts within gMSAT SM, fostering collaboration and technical alignment. You shape and influence global strategic processes and establish harmonized analytical standards, which are essential for future success. Develop a long-term strategy to harmonize processes and foster collaboration among the Center of Analytics, QC Network, Technical Development, and gMSAT for Synthetic Molecules (from DS to DP) to sustainably strengthen quality assurance, regulatory compliance, and efficiency for Synthetic Molecules (DS and DP) across the global network. Serve as Business Process Owner (BPO), act as the key interface between the Center of Analytics, global Quality, and gMSAT for commercial products, defining coordinated strategic processes and driving their implementation across the network. Act as the matrix leader for the gMSAT analytical SMEs while also leading a number of analytical sub-teams for selected commercial synthetic molecule products. Organize and lead exchange platforms, such as regular meetings with the Center of Analytics, global QC, and R&D to share best practices and further develop processes. Support and drive methodical or procedural improvements across the global analytical network. Play a key role in Analytical Control Lifecycle Management for our portfolio of commercial synthetic molecule products, taking responsibility for transferring analytical methods to our CDMOs (Contract Development and Manufacturing Organizations) for Drug Substance (DS), Starting Materials, and Intermediates. Who you are You have significant cross-functional matrix leadership experience and the ability to architect and shape in a complex and ambiguous environment. You bring the following qualifications: 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 industry experience in analytical method development, validation, or Quality Control (QC) support for Drug Substance (DS) or Drug Product (DP) manufacturing. In-depth conceptual and practical knowledge of the Analytical Lifecycle (ICH Q2, Q14) and its application to synthetic molecules, including definition of the Analytical Target Profile (ATP), impurity characterization, and control strategy development. Demonstrated experience with ICH Q8 and ICH M4 expectations, ensuring regulatory submissions and the control strategy are aligned with the manufacturing process. Experience supporting both DS and DP analytical activities for commercial products at CDMOs as well. Ready for the next step? This is your opportunity to play a significant role in harmonizing and advancing global analytical processes while reporting directly to the Global Head MSAT (SM). In this capacity, you combine operational expertise in analytical transfer with strategic process ownership for global networks and collaborate with international expert teams. We look forward to hearing from you! Who we are 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The Principal Analytical Steward will architect and implement a global analytical framework for commercial synthetic molecules, serving as the Business Process Owner. They will provide matrix leadership to analytical SMEs and manage analytical control lifecycles across the global network and CDMOs.