Senior Process Steward role at Roche Global MSAT. Support process industrialization, tech transfers & continuous improvement for large molecule (CHO/E.coli) DS processes. 7+ yrs exp in bioprocess dev/engineering & tech transfer req. #Bioprocessing #MSAT #ProcessEngineer #PharmaManufacturing #RocheCareers
Drive Global Process Robustness for Life-Changing Biologics
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, allowing you to thrive. This is how we aim to prevent, stop, and cure diseases. Join Roche, where every voice matters.
The Position: Global MSAT DS Senior Process Steward
A healthier future drives us to innovate. Pharma Technical Technology (PTT) enhances industrialization and product management. Within this, the Global MSAT team manages commercial products and new technologies. As a Senior Process Steward for Large Molecule Drug Substance (DS), you are the critical link between global MSAT and our manufacturing network. You will drive process robustness, lead technical improvements, support second-source transfers, and provide deep technical expertise to ensure the reliable supply of our biologic medicines.
The Opportunity: Be the Technical Anchor for Global Processes
You will ensure our manufacturing processes remain in a validated state, are continuously improved, and are effectively transferred across the internal and external network.
Key Responsibilities:
1. Process Industrialization & Risk Management
- Support Product Technical Leads in ensuring process industrialization.
- Coordinate process gap assessments, integrate risks into logs, and develop mitigation strategies.
- Drive systematic process and product health improvements based on data insights.
2. Technical Support & Investigations
- Provide hands-on second-level support for complex investigations, CAPAs, and troubleshooting across the manufacturing network.
- Lead non-product specific Root Cause Analyses (RCAs).
- Execute validated state support activities (e.g., VICs) to ensure ongoing compliance.
3. Technology Transfer & Network Initiatives
- Support second-source and technology transfer projects, leveraging pilot plant teams for scaled experimentation and validation studies.
- Ensure implementation of network-wide initiatives aligned with site plans, including direct material changes and Health Authority requirements.
4. Collaboration & Digital Enablement
- Collaborate closely with global/site functions and other gMSAT teams.
- Serve as a digital enabler, translating business needs to digital strategy teams to drive technical sustainability improvements.
Who You Are: The Bioprocessing Expert & Collaborator
You are a seasoned process engineer with a passion for technical problem-solving and a track record of leading in a matrix environment.
Your Profile:
- B.S. or M.S. degree in Chemical/Biochemical Engineering or a related discipline. A PhD is advantageous.
- 7+ years of relevant industrial experience in process development, process engineering, or manufacturing operations within biopharma.
- Demonstrated experience in E. coli & CHO processes, including process validation and technology transfer.
- Familiarity with pharmaceutical quality systems, regulatory submissions, and health authority requirements.
- Experience in collaborative, matrix team leadership and decision-making.
- Advanced verbal and written communication skills, with the ability to articulate complex topics to senior leadership.
- Willingness to travel <10% as required.
Why Build Your Career at Roche?
1. Impact on a Global Scale
- Your work directly ensures the robust, reliable manufacturing of medicines that treat over 26 million people.
- Solve complex technical challenges at the intersection of science, engineering, and global supply.
2. Technical Leadership & Growth
- Step into a senior technical role with network-wide influence on process strategy and continuous improvement.
- Work at the forefront of bioprocessing technology within one of the world’s leading healthcare companies.
3. A Culture That Empowers You
- Join over 100,000 employees dedicated to advancing science.
- Thrive in an environment that values personal expression, open dialogue, and genuine connection.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Ready to Steward the Processes Behind Our Biologics Pipeline?
If you are a bioprocessing leader ready to apply your expertise to ensure global supply and drive technical excellence, we encourage you to apply.
