[Hiring] Research Scientist @Gambro Dialysatoren

Role Description

As Research Scientist – Preclinical Biocompatibility and Toxicology (m/f/d) you will apply expertise in toxicology and medical device biocompatibility testing including development of toxicity study design and biocompatibility testing design for drug/drug packaging system/medical device development, monitoring the studies, and development of toxicological risk assessments.

The role will report to Director of Preclinical (Biocompatibility and Toxicology) and will be part of a global team responsible for drugs and devices for Peritoneal dialysis, Hemodialysis, and Acute therapies.

Qualifications

• Degree in toxicology, pharmacology, chemistry or other related scientific field
• MS degree with 8 years or more relevant experience or PhD with 4 years or more relevant experience in the pharmaceutical/medical device industry in GLP/GMP environments
• Proven experience with the conduct and execution of GLP nonclinical safety (toxicology) and toxicological risk assessment on Extractable & Leachable is highly preferred
• Experience with safety and biocompatibility evaluation of medical devices and related regulatory guidance (USP, ISO 10993, EU MDR, etc)
• Relevant knowledge of ISO 10993-1, ISO 10993-17 and ICH Q3 M7 guidelines required
• European Registered Toxicologist (ERT), Diplomate of American Board of Toxicology (DABT) desired
• Experience in OECD and FDA Good Laboratory Practice
• Shown technical writing ability and oral presentation skills
• Ability to work independently and prioritize assignments to meet project schedules
• Can effectively collaborate in a global team
• Excellent English language skills, spoken and written

Requirements

• Designing, planning, monitoring various GLP toxicity studies, biocompatibility studies, and qualification of impurities with some supervision from direct manager and senior members of the organization
• As sponsor representative and subject matter expert (SME) of biocompatibility, collaborate with external testing facilities to complete biocompatibility testing
• Participate as preclinical/toxicology representative and contribute in core technical team meetings as SME
• Participate in change control management and impact assessment
• Maintain current knowledge of relevant regulatory requirements related to toxicology, product development, design and safety
• Execute tasks within budget at the project level to ensure the best utilization of financial resources

Company Description

Have we sparked your interest?

If you like the sound of the above role, can thrive in a fast-paced working environment and are excited about working in a learning and growth culture, then we’d love to talk to you. Apply direct on our Online System.