Research Scientist – Preclinical Biocompatibility and Toxicology (m/f/d)

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 drugs and devices for Peritoneal dialysis, Hemodialysis, and Acute therapies.

What you'll be doing

• 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 and provide inputs and lead task to be executed for completion of projects with effective collaboration and deliverables
• Participate in change control management and impact assessment. Propose options, work closely with stakeholders and develop action plan for problem-solving, product and process improvement
• 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

What you'll bring

• Degree in toxicology, pharmacology, chemistry or other related scientific field, with the following minimum previous experience working in the pharmaceutical/medical device industry in GLP/GMP environments: MS degree with 8 years or more relevant experience or PhD with 4 years or more relevant experience
• 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 to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions
• Ability to work independently and prioritize assignments to meet project schedules
• Can effectively collaborate in a global team, including ability to work with individuals of diverse scientific and cultural backgrounds across multiple business units as well as with external partners/CROs
• Excellent English language skills, spoken and written

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.