Senior Clinical Research Associate

Preclinical Biocompatibility and Toxicology SME (Research Associate III)

In this role the Researcher of Preclinical (Toxicology and biocompatibility) 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 successful candidate will have hands-on experience in hazard evaluation of chemicals used in manufacturing. You will participate in preparing reports for external regulatory bodies in accordance with ICH and ISO10993 to assure product (patient) safety and efficacy through the application of current pre-clinical science, non-clinical safety assessment, and toxicological principles and methods. These will be used to enable and support new product development (NPD), sustaining product organization (SPO) and margin improvement projects (MIP) and associated product development lifecycle management (PDLM) processes and initiatives. 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 (~$5B product portfolio with global reach in more than 100 countries).

• Design, plan and monitor various GLP toxicity studies, biocompatibility studies, and qualification of impurities with some supervisions 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.

• Relevant knowledge of ISO10993 and ICH Q3 M7 guidelines required.
• 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.

• 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 6 years or more of relevant experience or
• PhD with 3 years or more of 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, ISO1093, EU MDR, etc).

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research
• Industries: Pharmaceutical Manufacturing