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The Assay Development team is responsible for the development of molecular diagnostic and screening tests based on PCR technology in the areas of infectious diseases, genomics, and oncology, from early feasibility to commercial launch. Our main areas of responsibility include initial prototyping; optimization of assay design to meet product requirements and ensure manufacturability; development of test methods and acceptance criteria; transfer of reagent manufacturing instructions, test methods, and workflows to Operations; the design and execution of verification and validation activities, including guard-band studies, stability studies, and technical performance verification studies; and documentation of analytical performance for product labeling and regulatory submission packages. Throughout the product development phases, Assay Development interfaces with various departments including Research, Operations, Quality, Regulatory, and Business in order to create and realize what patients need next.
General Information:
* 1 year duration (with possible extension)
Tasks &; Responsibilities:
* Working with high throughput lab – analyzer
* Routine lab work with infectious samples and leading of own experiments including the analysis of them
* Plan and execute different work packages for the development of molecular diagnostics test
* Participation in project meetings and presentation of experimental data
* Precise documentation of experiments using electronic lab journals according to GMP Standards
* Equipment handling and maintenance
* Statistical data analysis using different software and tools (e.g. JMP)
* Author official documents (e.g. Design History Files)
* Chemical waste management: empty bins, expired materials
* Responsible for a small chemical support team (2-3 people) and involved in hiring activities of new team members, onboarding activities and development of chemical team members, in collaboration with the AD People Leaders
* Proactively Identify areas for lab workflow improvements in the biosafety level 2 laboratories of Assay Development and drive the implementation in the function as Lab Workflow Lead in collaboration with department internal and external stakeholders
Your profile:
* Graduate as Biomedical Analyst Scientist (BMA HF) or apprenticeship as Lab Technician (Biology, Medical Diagnostics, Chemistry) or at least Bachelor or Master degree in Life Sciences with practical experience from the Lab.
* Ideally 2+ years of lab experience with data analyses and biostatistics
* Very good and thorough documentation skills
* Strong communication skills in English and German
* Open-minded team player
* Pro-active mindset and organized working style
* Flexible, strategic thinking and self-dependent person
* Lab experience from a biotechnical environment with infectious sample handling Biosafety
* Experience in a GMP/GLP environment Level 2
Nice to haves
* Basic leadership experience (1+ years, ideally with a team of at least 2-3 employees)
* Preferably skilled in IT/Software applications such as SAP, Signals eLN, Monday, Excel and others
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Science and Research
* Industries
Pharmaceutical Manufacturing
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