Job Description
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
The Quality Control (QC) Microbiology Team at our Werthenstein BioPharma site in Schachen supports the production and release of new clinical candidates with environmental monitoring and testing of Drug Substance (DS) and all in-process intermediates thereof. Moreover, as part of the Research & Development Division Center of Excellence (CoE) for Microbiology, with the global team we support the totality of the portfolio including small molecules, biologics and vaccines and have an assignment for the assessment and introduction of rapid microbiological methods (RMM), other new technologies and automation to eventually allow more efficient and faster testing and release of DS.
The Microbiology department is hiring a Senior Specialist to join the team. This is a laboratory-based scientific role tasked with solving complex analytical challenges at the interface of microbiology quality control and the implementation of rapid microbiological methods. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

REQUIRED EDUCATION:

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

REQUIRED EXPERIENCE AND SKILLS:

• Subject matter expertise on microbiological quality control and environmental monitoring.
• Work experience in a regulated environment, GMP-knowledge.
• Ability to think logically and be proactive under pressure.
• Ability to work in a team environment with cross-functional interactions.
• Strength in delivering results on firm deadlines in support of our pipeline.
• Effective communicator and deep technical expertise in science, to be able to share and communicate that knowledge through training of analysts.

PREFERRED EXPERIENCE AND SKILLS:

• Knowledge of design and operation of laboratory information systems such as MODA-EM, Veeva Vault QualityDocs, ProCal and SAP.
• Specific interest and experience in working with AI to automate lab processes.

LANGUAGE REQUIREMENTS:

• Fluent in German and English.
  Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

TRAVEL REQUIREMENTS:

10%

• Applying microbiology expertise as a subject matter expert for quality control in biologics production and raw materials testing.
• Driving technical and business deliverables through individual contributions managing most work with minimal guidance.
• Planning and overseeing the execution of microbiological studies, method verifications, method validations, and method transfers including report authoring.
• Providing technical guidance as well as critical thinking to help resolve complex scientific and technical problems by identifying innovative solutions.
• Authoring and revising Standard Operating Procedures.
• Initiating, investigating, and closing deviations originating from the microbiology department.
• Second person reviewing of analytical data.
• Driving compliance with our policies, procedures and guidelines and regulatory requirements Good Manufacturing Practices (GMP)
• Cultivating and leveraging working relationships with stakeholders within the department as well as across the organization to contribute to the continuing establishment of the Research & Development Division Micro CoE.