You lead microbiology lab operations, ensuring compliance with regulations while managing personnel and resources. Your role includes overseeing testing methods, collaborating with teams, and driving process improvements.
Anforderungen
- •Bachelor’s degree in Microbiology or related field
- •Minimum of 5 years in GMP-regulated lab
- •Strong knowledge of pharmaceutical microbiology
- •Experience with regulatory inspections
- •Proven matrix leadership ability
- •Experience with laboratory information systems
- •Detail-oriented with strong organizational skills
Deine Aufgaben
- •Lead daily microbiology laboratory operations.
- •Manage scheduling and resource planning.
- •Supervise laboratory personnel effectively.
- •Ensure compliance with GMP and FDA guidelines.
- •Conduct microbiological testing and monitoring.
- •Provide oversight for microbiological methods and validations.
- •Troubleshoot investigations for OOS and deviations.
- •Act as a Subject Matter Expert in microbiology.
- •Oversee environmental and utility monitoring programs.
- •Support cleanroom qualification efforts.
- •Coach laboratory technicians on quality and improvement.
- •Collaborate with Quality Assurance and Manufacturing teams.
- •Support inspections and internal audits with expertise.
- •Implement new technologies and rapid microbiological methods.
- •Optimize processes for efficiency and effectiveness.
- •Ensure accurate documentation and data integrity.
- •Maintain a safe working environment and compliance.
Original Beschreibung
# Microbiology Expert - Planning and Coordination Lead
**Kaiseraugst** | **Full time**
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### The Position
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.
* 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.
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**Roche is an Equal Opportunity Employer.**