Senior Specialist Microbiology

Company Overview

We are a research-driven biopharmaceutical company committed to the principle that “following the science” can lead to the development of transformative medicines that significantly impact lives worldwide. Our focus on world-class science enables us to innovate in medicine and vaccine development, providing solutions that improve patient outcomes globally.

Position Overview

The Quality Control (QC) Microbiology Team at our Werthenstein BioPharma site in Schachen plays a crucial role in supporting the production and release of new clinical candidates. This involves environmental monitoring and testing of Drug Substance (DS) and all related in-process intermediates. As part of our Research & Development Division's Center of Excellence (CoE) for Microbiology, we collaborate on a diverse portfolio that includes small molecules, biologics, and vaccines, with a focus on integrating rapid microbiological methods (RMM), new technologies, and automation for more efficient testing and release processes.

Job Opportunity: Senior Specialist

We are looking for a Senior Specialist to join our Microbiology department. This laboratory-based scientific role is essential for addressing complex analytical challenges at the intersection of microbiology quality control and the implementation of rapid microbiological methods. The ideal candidate will thrive in a fast-paced, integrated, multidisciplinary team environment.

Main Responsibilities

• Act as a subject matter expert in microbiology for quality control in biologics production and raw materials testing.
• Drive technical and business deliverables with minimal guidance, managing various tasks effectively.
• Plan and oversee microbiological studies, method verifications, validations, and transfers, including report writing.
• Provide technical guidance and critical thinking to solve complex scientific and technical issues through innovative solutions.
• Author and revise Standard Operating Procedures (SOPs).
• Initiate, investigate, and resolve deviations from the microbiology department.
• Review analytical data as a second reviewer.
• Ensure compliance with policies, procedures, guidelines, and regulatory requirements such as Good Manufacturing Practices (GMP).
• Foster and leverage relationships with stakeholders within the department and across the organization to further establish our Research & Development Division Micro CoE.

Required Education

• PhD in microbiology or a related field with 3 or more years of relevant experience in the pharmaceutical industry.
• Masters or Bachelor of Science in microbiology or a related field with 5 or more years of relevant experience.
• Completed apprenticeship (lab technician EFZ in Biology) with 7 or more years of relevant experience.

Required Experience and Skills

• Subject matter expertise in microbiological quality control and environmental monitoring.
• Experience in a regulated environment with strong GMP knowledge.
• Logical thinker who can be proactive under pressure.
• Ability to collaborate in a team-oriented environment with cross-functional interactions.
• Proficiency in delivering results within stringent deadlines to support our pipeline.
• Strong communication skills and deep technical expertise, with the ability to share knowledge through training.

Preferred Experience and Skills

• Familiarity with laboratory information systems such as MODA-EM, Veeva Vault QualityDocs, ProCal, and SAP.
• Interest in and experience with AI applications to automate laboratory processes.

Language Requirements

• Fluency in both German and English is required.

Our Clinical and Pharmacovigilance teams manage critical studies to gather safety and efficacy data needed for regulatory approval of new drugs, vaccines, and new indications for existing products. We are committed to conducting high-quality clinical trials by integrating advanced technology and adhering to rigorous scientific and ethical standards.

Company Commitment

With a presence in Switzerland since 1963, our company operates a regional office and manufacturing/packaging facility in Lucerne, employing around 1,000 collaborative professionals across multiple locations. Our new establishment in Zurich focuses on accelerating the development and commercialization of our medicines and vaccines, furthering our mission to enhance and save lives globally.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe,” reflecting our commitment to our employees and the community. Our Werthenstein BioPharma site in Schachen is dedicated to cutting-edge research, new biological product development, and the supply of clinical trial products for global studies. This site also houses a global forensic laboratory, ensuring product security and safety through the supply chain.

Apply online using the form below. Please note that only applications matching the job profile will be considered.