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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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