Biologist - Process Qualification, Quality Assurance (m/f/d)

Beschreibung

• Transfer FMI wet-lab technology to international collaboration partners
• Preparation and maintenance of training material (SOP, training logs, presentations) in full alignment with FMI’s most up-to-date standard protocols
• Conduction of on-site training at partner sites including hands-on training, and support writing detailed, accurate, and accessible experimental plans
• Work cross functionally at FMI with a special focus on Quality Assurance to support process qualification and process performance qualification at partner sites
• Coordination and conduction of concordance studies between partner sites and FMI collaborating with both QA and Lab Operations
• Compiling data and support summarizing results of validation and concordance study
• Foster FMIs collaboration with external partner sites and present as reliable point of contact within FMI International Operations team
• Position requires ability to travel internationally (up to 20%)

• You hold a Masters’ degree in Molecular Biology or in a related field
• You have a background in cancer biology and basic experience in Quality Assurance
• You have understanding of laboratory techniques especially hands-on experience with NGS and associated methodologies including DNA-seq and RNA-seq protocols, and various target-enrichment approaches (e.g. multiplex-PCR, hybrid selection)
• Working with typical oncology specimens (e.g. FFPE, Blood, Bone Marrow) is familiar to you
• You are experienced in the validation and implementation of ISO 15189-certified tests including writing SOPs and validation plans/reports
• You have a demonstrated scientific background and capability to conduct and coordinate validation studies and summarizing data for internal and external presentations.
• Last but not least you have good communication skills and the capability to establish strong relationships to FMI internal and external stakeholders

• You can expect a high degree of independence and a flexible working environment
• We stand for sincere and trust-based interaction with each other
• Your personal and professional development is very important to us
• All the advantages of a familiar work environment while being embedded in a large, global company