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
Please consider before handing in your application that for this position we’ve already identified a suitable candidate.
The Opportunity
Our Facilities Management and SHE department (approximately 40 employees) for our Basel DS Manufacturing site ensures that the production and delivery of drug substance is uninterrupted and reliable.
You are the Microbial Manufacturing Process Manager, responsible for the microbial oversight of the Manufacturing Process within Basel DS Manufacturing Large Molecules. You are part of the Microbial Team and provide support in all Monitoring areas.
Your key responsibilities are:
Ensure compliance of local procedures with company-wide quality policies and GMP standards while maintaining full strategic responsibility for microbial manufacturing processes.
Act as SME for microbial topics, including troubleshooting contamination issues and supporting Basel Drug Substance Manufacturing with Lean Methodology and continuous improvement.
Coordinate discrepancies/investigations, define corrective and preventive actions (CAPAs), and ensure timely resolution of issues in collaboration with responsible areas.
Oversee and review monitoring activities for environmental and utility systems in collaboration with QC Microbiology EMT Basel and IT Kaiseraugst.
Provide support and review periodic environmental and utility monitoring reports while editing required documents in Veeva.
Participate in relevant teams and global networks, while supporting regulatory inspections and partner audits as SME.
Deputize for the Monitoring Manager for EMT and Utilities and actively engage in preventive measures to drive continuous improvements.
Who you are
You are working in a diverse environment and you are demonstrating flexibility, agility and initiative. You bring the following qualification:
You hold a Master’s Degree (microbiology or other relevant life science discipline)
Any Microbial Manufacturing Process experience is highly valuable
Deep knowledge in aseptic handling
Preferably minimum of 5 Year work experience in the biotechnical or pharmaceutical industry (manufacturing, or process development)
A deep understanding of cGMP
Good Interpersonal skills and the ability to connect with different functions
Fluent German and English skills
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.