Associate Quality Control Microbiology - Switzerland
- Our company is building a new, Next-Generation Biologic Manufacturing Facility with high throughput production capacity.
- Rapid microbiological methodologies, such as PTS and Growth Direct in combination with highly efficient testing strategy will be instrumental in reducing the time required onsite to complete microbiological analysis for in-process and Drug Substance testing.
- The facility will utilize new technologies pioneered by our experts in technical development and employ an innovative, world-class engineering design to deliver substantially increased productivity. To help us setting-up this project we are looking for an Associate Quality Control Microbiology.
Job Purpose and Responsibilities
- The Associate Quality Control Microbiology will execute all of the Microbiology-related testing activities during preparing the new Microbiology lab and Work-in Progress (WIP) labs for routine operations and support the execution of the analytical capability strategy, which includes:
- Support acquisition of the analytical instruments in the Microbiology lab and Work-in Progress (WIP) labs
- Support generation of equipment qualification and method validation documents
- Perform qualification of the analytical instruments according cGMP requirements
- Perform validation of traditional microbiological methods as well as automated and rapid state-of-the art methods, such as microbiological identification (PRC-based method), Bacterial Endotoxins Test (kinetic-turbidimetric and kinetic-chromogenic), detection of microorganisms (BacT/Alert) and microbial enumeration test
- Perform routine analysis of microbiological samples as well as Total Organic Carbon and Conductivity
- Provide support that the instrumentation in the WIP labs are prepared for each corresponding unit operation to be performed in manufacturing
- Support day to day operations within the Central and WIP labs
- Support training of the On-The Floor (OTF) Quality staff members that will perform routine test execution in the WIP labs
- Support trouble shooting and root cause analysis in order to prevent reoccurrence
- Support all start-up activities for the new lab, e.g. definition and implementation of workflows and issuing standard operation procedures
- Support the facility certification with respect to the environmental monitoring (EM), utility monitoring (UM) and compressed gas distribution validation.
- Author, review and approve complex GMP documentation (Plans, protocols, procedures, specifications, CAPAs, deviations, etc.) according cGMP and regulatory requirements.
- The opportunity to join a world-class company and participate in building up a next generation biopharmaceutical facility
- A permanent contract with superior compensation, sustainable learning and great development opportunities in a fast paced multicultural environment
- Minimum of 4 years of experience in regulated (bio)pharmaceutical quality control environments
- Strong experience within Biological Quality Control, Microbiology and analytical function
- Profound knowledge with the Quality systems and business processes associated with Microbiology testing (drug substance) and good understanding of modern analytical microbiological modalities
- Must have strong technical skills and be proficient with typical productivity software (Word, Excel, Power Point, Visio, etc.)
- Strong problem solving skills, ability to multi-task operations, working autonomously and cross-functional
- Demonstrated ability to work autonomously
- Very good command of German and English
Apprenticeship degree and/or Bachelor degree in Biology or related Life Science or Technical discipline
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS).
- Our company also manufactures and commercializes biosimilars of advanced biologics.
- Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry.
- To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion.
- As a company, we are focused on improving science education and limiting the impact of our company on the environment.
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