Microbiology Expert - Planning and Coordination Lead at F. Hoffmann-La Roche Ltd - Poland

Kaiseraugst, Aargau, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

30 Dec, 25

Salary

0.0

Posted On

01 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology, Aseptic Processing, Environmental Monitoring, GMP Compliance, Regulatory Standards, Matrix Leadership, Team Building, Troubleshooting, Quality Assurance, Data Integrity, Documentation, Continuous Improvement, Coaching, Laboratory Operations, Contamination Control, Cleanroom Qualification

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 A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. The Microbiology and environmental monitoring group is part of the Microbiology Section within the Quality Control department in Kaiseraugst/Basel. The Opportunity We are seeking an experienced and motivated Microbiology Expert and Planning and Coordination Lead to oversee all microbiological operations within our pharmaceutical quality control (QC) laboratory in Kaiseraugst. This individual will play a critical matrix leadership role, ensuring compliance with regulatory standards, driving continuous improvement, and mentoring a high-performing microbiology team. The ideal candidate brings deep expertise in microbiological techniques, aseptic processing, and environmental monitoring within a GMP-regulated pharmaceutical environment. Key Responsibilities: Lead and manage daily microbiology laboratory operations, including scheduling, resource planning, and personnel supervision. Ensure all microbiological testing (e.g., product bioburden, water sampling, environmental monitoring) complies with GMP, FDA, and international regulatory guidelines. Provide scientific oversight and troubleshooting for microbiological methods, validations, and investigations (e.g., OOS, deviations, CAPAs). Serve as a site Subject Matter Expert (SME) for microbiology, aseptic practices, and contamination control. Oversee environmental and utility monitoring programs and support cleanroom qualification efforts. Coach a team of laboratory technicians, promoting accountability, quality, and continuous improvement. Collaborate with Quality Assurance and Manufacturing, offering microbiological expertise and supporting inspections and internal audits. Drive the implementation of new technologies, rapid microbiological methods, and process optimizations. Ensure accurate documentation, data integrity, and timely reporting of test results, adhering to ALCOA+ principles and maintain a safe working environment and ensure compliance with health and safety regulations. Who You Are Possess at least a Bachelor’s degree in Microbiology, Biology, or a related life science discipline (Master’s or PhD preferred). Have a minimum of 5 years of experience in a GMP-regulated microbiology laboratory. Demonstrate strong knowledge of pharmaceutical microbiology, including sterile manufacturing, environmental monitoring, and contamination control and have experience with regulatory inspections (e.g., FDA, EMA) and a solid understanding of global regulatory expectations. Exhibit proven matrix leadership ability with excellent interpersonal, communication, and team-building skills. Experience with laboratory information systems (LIMS), quality systems, and data analysis tools is desirable and be detail-oriented, with strong organizational and decision-making abilities. Fluent German Required / Business English Desired. To apply, please submit your CV, a cover letter, and copies of your diploma(s). We look forward to receiving your application! 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

Lead and manage daily microbiology laboratory operations, ensuring compliance with regulatory standards and driving continuous improvement. Mentor a high-performing microbiology team and provide scientific oversight for microbiological methods and validations.