Sr. Toxicologist-Laboratory Blood Management-Boston, MA

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Summary

The Senior Toxicologist is responsible for the evaluation of medical device (MD) products and combination products for safety per USP and the ISO 10993 Standard series. The role is responsible for assisting in the design and implementation of test systems and procedures for the governance of biocompatibility testing.

Client Details

My client throughout their history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, their products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals.

Description

The main responsibilities for the Sr. Toxicologist are

• Plans and manages the impact assessment of manufacturing, supplier, and material changes to medical devices with patient contacting components to ensure biological safety and product sustainability.
• Review, interpret, and summarize raw data from Contract Research Organization reports and documents biological assessments using sound scientific principles.
• Ensure that testing meets all international & domestic test requirements according to ISO, FDA, EU MDR, and GLP Conduct quantitative risk assessments on chemical characterization profiles as a part of biocompatibility evaluations.
• Apply technical expertise to solve complex biocompatibility problems as related to the ISO 10993 standards and regulatory authority requirements for product safety

Profile

The successful Sr. Toxicologist will have:

• Bachelor's degree in Toxicology, Biology, Chemistry, or related science
• 7+ years of experience with a Bachelor's degree or 5+ years of experience with an advanced degree conducting toxicological risk assessments
• Functional expert in the principles Biocompatibility and Toxicological Risk assessment.
• Knowledge of applicable ASTM, ISO, FDA, and EN standards with an in-depth understanding of ISO 10993 biocompatibility standards
• Knowledge of pertinent sections of REACH, the EU MDR, and Proposition 65 (hazardous substances regulations) as well as ICH and FDA Guidance Documents (e.g., Threshold of Toxicological Concern and Use of ISO 10993-1).
• Proficient in Microsoft suite of applications

Job Offer

If you are interested in this opportunity, please apply directly and all qualified candidates will be contacted. This role offers a competitive salary and bonus structure that is commensurate with current salary and experience.

The client is an equal opportunity employer.