MSAT Senior Process Expert USP

F. Hoffmann-La Roche AG; Basel; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Roche Basel Biotech Manufacturing (MSAT) seeks a senior Process Engineer to build and optimize upstream bioprocess capabilities. You will coach SMEs, drive cross-site projects, and lead technical decisions to improve safety, quality and efficiency of monoclonal antibody and ADC production.

The role requires 8+ years in industry manufacturing, with cGMP experience and strong German/English communication. On-site work with potential for on-call support is expected.

Qualifikationen

• Master or PhD in biotechnology, biochemistry or bio/chemical process engineering.
• Extensive experience in upstream bioprocesses within a cGMP manufacturing environment.
• Strong leadership and collaboration skills to drive technical projects.

Aufgaben

• Build, sustain and improve technical capabilities for Process Engineering; coach SMEs.
• Collaborate across Roche to support strategic initiatives and lead tech projects.
• Champion Lean Leadership and continuous improvement for mid/long term goals.
• Analyze end-to-end production processes to identify safety, quality and cost improvements.
• Coordinate troubleshooting with pilot labs, production and quality teams.
• Lead root cause analyses and drive standardization between sites and networks.

Kenntnisse

Lean Leadership

cGMP Experience

Bioprocess Upstream

Project Coordination

Cross-cultural Communication

Ausbildung

Master's or PhD in biotechnology/biochemical engineering

Jobbeschreibung

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 Basel Biotech Manufacturing produces biotech drugs such as monoclonal antibodies (mAb) and antibody-drug conjugates (ADC) for clinical use and commercial distribution. The MSAT department is a technology unit supporting production at Basel DS Manufacturing.

The Opportunity

• Building, sustaining and improving the technical capabilities in the group for the area of responsibilities of the Process Engineering chapters incl. coaching and mentoring of technical SMEs and provide recommendations for technical decisions
• Collaborating with technical experts across Roche to support strategic initiatives across the Roche manufacturing network and leading technology and innovation projects within the site and/or the network
• Embodying Lean Leadership principles and living a culture of continuous improvement to foster an environment of strong team spirit, timely and efficient communication, sense of urgency, high motivation and passion, in order to deliver mid/long term goals
• Supporting the analysis of end-to-end production processes and facility capabilities to identify opportunities for improvement regarding safety, quality, robustness of supply, reduce operational costs and lead times, and prevent problems
• Planning and coordination of troubleshooting activities in collaboration with the pilot laboratories, production, and the quality department
• Driving technical standardization and knowledge exchange in-between SUT and MAB stainless steel plant, serving as an SME in inspections and as a lead of root cause analysis teams for complex deviations
• Being a Site Representative in Network Teams i.e. UoTs, (Unit operation Teams), MPET (Manufacturing Process Evaluation Team) and becoming Site SME and decision maker in strategic technical changes
• Becoming the primary contact for partners in the Roche Biologics Drug Substance network (such as other manufacturing sites, PTI, PTD, DSTLs, other functions and external partners) for the exchange and collaboration in the area of MSAT
• Owner of the production processes (interface between Manufacturing and MSAT) as well as carrying out data analysis as part of process monitoring
• On-call Service occasionally possible.

Who You Are

• You have an academic degree in a scientific or technical area (Master or PhD), preferably in biotechnology, biochemistry or bio/chemical process engineering.
• 8+ years of relevant experience in industry (manufacturing), 6+ years of relevant experience in manufacturing with bioprocesses, and needs experience working in a cGMP environment.
• Good knowledge of safety principles, quality systems, and cGMP and has done relevant work experience in a lab, pilot plant, manufacturing, or manufacturing support setting.
• Extensive knowledge in the field of upstream processing of biotechnologically manufactured products with the ability to adapt to a rapidly changing environment with changing priorities and to react flexibly to requests.
• Very good (intercultural) communication skills with fluency in German and English.
• Knowledge of process validation, process transfers, and single-use technologies would be an advantage.
• On-call Service occasionally possible.

Ready to make an impact and contribute to our exciting journey?

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.