LDT/IVD Documentation Specialist (m/f/d)
Welcome to CENTOGENE!
CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. We integrate multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next generation of precision medicine. Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease states, and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.
How do we do this? By bringing together more than 400 individuals from 50 different countries at our HQ in Rostock, Germany, as well as our offices in Berlin, Belgrade, and laboratory facilities in Cambridge, MA. Our employees are medical experts, scientists, IT professionals, bioinformaticians, technicians, researchers, project managers, and many more – and are all passionate about supporting our company vision : A world healed of all rare and neurodegenerative diseases.
Does this sound like you? If it does, we’d love to hear from you!
Your tasks will be:
- Working within the Product & Method Development Department
- Interacting with multi-disciplinary teams
- Being the interface to the Regulatory & Quality Management team for in-house Lab Developed Tests (LDTs)
- Creating and maintaining the technical documentation for in-house LDTs/IVDs according to Regulation (EU) 2017/746
You have the following skills and qualifications:
- Completed scientific degree (M.Sc. or higher)
- At least 2 years working experience in a (medical) laboratory setting
- Knowledge of regulatory framework regarding LDT and in-house IVDs, e.g., ISO 13485, ISO 15189, (EU) 2017/746
- Experience in scientific writing
- Scientific background in e.g., Next Generation Sequencing, Sanger Sequencing or Deletion/Duplication Analysis is a plus
- Highly organized and able to deliver projects within agreed timeframes
- Good communication and time management skills
- Business fluent in English
Those advantages are waiting for you at CENTOGENE:
- Talents are individually supported by internal and external trainings
- An international career in a multicultural environment
- Regular company events form us as one team
- In house yoga classes, back exercises and a fitness area are available for free
- Lunch breaks and meetings on our roof terraces feel like vacation when looking at the Warnow
- Bike-leasing or job tickets allow an environmentally-friendly and reasonable travel to work
- In case of language barriers, we offer German and English classes as well as support in finding accommodation to help you get going
- Precaution and financial protection guaranteed by company pension scheme
Scope of activities
OtherCareer level
ProfessionalLocation
Am Strande 7, 18055 Rostock, GermanyEmployment type
Full timeFor those who embark on a career with CENTOGENE, they’ll enjoy an exciting, dynamic, entrepreneurial and extremely fast-paced environment. Working alongside dedicated colleagues, CENTOGENE employees enjoy other benefits including upskilling from a dedicated training department, yoga classes, company-sponsored bicycle leasing, German language classes, and new state-of-the-art premises conveniently located featuring roof terraces and an in-house fitness center. For employees new to Rostock we’ll also support on finding local housing.
Who we are
CENTOGENE is a rare disease company focused on transforming clinical, genetic, and biochemical data into medical solutions for patients. We are focused on bringing rationality to treatment decisions and accelerating the development of new orphan drugs by using our knowledge of the global rare disease market, including its epidemiological and clinical heterogeneity and our innovative biomarkers.
As one of the largest rare disease companies worldwide, CENTOGENE is dedicated to transforming the science of genetic information into solutions and hope for patients with rare diseases and their families.
