Investigative Toxicology Associate Scientist

Investigative Toxicology Associate Scientist

* The general nature of the position is to semi autonomously support the evaluation of the safety of medical devices by coordinating biocompatibility testing which may include the development of strategies, protocols, project plans, and reports.

Principal Duties and Responsibilities (essential functions)
* Working under minimal supervision, conduct research and contribute to the origination and direction of experiments and new methodologies. Prioritize tasks according to broad project goals. Actively involved with technical consultants/mentors.
* Ability to apply broad range of scientific principles to new products/technology concepts using innovative creative thinking and innovative techniques.
* Good teamwork and oral/written communication skills for projects, presentations and technical reports are a must. Computer literate in office applications is required.
* Develops protocols conducts studies, analyzes test results and prepares technical reports, and/or position/white papers for internal or external use. Act as study coordinator and work with the Sponsor's Representative to coordinate and oversee studies performed at a CRO. This includes submitting samples for Materials Characterization data and study initiation, reviewing protocols, coordinating communications with the CRO, obtaining and issuing internal Ethicon reports, and archiving the study data package.
* Work with project teams to identify needs and assist in the development of strategies aimed at supporting product development and regulatory submission.
* Perform the role of Histology Coordinator for all tissues sent to a CRO for processing. Coordinate the timely submission of tissues in order to ensure meeting study requirements. Coordinate internal distribution of materials received. Submit all tissues, blocks, and slides to the Histopathology Archives at Study termination.
* Develop, write, and implement Standard Operating Procedures to ensure compliance with FDA Good Laboratory Practices (21 CFR, Part 58) and compliance with requirements of the "Guide for the Care and Use of Laboratory Animals", and other applicable certifying agencies (i.e., AAALAC).
* Collaborate with associates of diverse technical backgrounds (chemistry, physiology, materials science, engineering, veterinary) to achieve desired project outcomes.
* Act as mentor for junior associates.
* 10% travel required.

Education and/or Experience
* BS or MS with 5+ years equivalent external experience.
* Toxicology degree is a plus
* Medical Device preferred but not required.
* Demonstrated ability to prioritize effectively, manage time efficiently and manage multiple activities simultaneously.
* History of working in an FDA regulated, Good Laboratory Practices environment.


Other Skills and Abilities
* Knowledge ISO 10993 regulations preferred.
* Good business/medical writing and oral communications skills.
* Ability to manage multiple priorities simultaneously.
* Applies Credo values in an open, honest and ethical manner.
* Focuses on Customer, Business Results and Supports Business Growth

This job was posted by Integrated Resources.