Scientist, Medical Technologist & Lab Technician

This role focuses on hands‑on preparation and testing of a wide range of medical devices within a contract research organization (CRO) environment, supporting in vitro and in vivo toxicology studies in accordance with ISO standards and Good Laboratory Practices (GLP). The scientist will prepare extractions from medical devices for dosing, work closely with study teams to execute protocols, and serve as a technical leader who trains and mentors less‑experienced staff.

This position plays a key role in supporting animal studies that contribute to the development of therapies, including those aimed at curing cancer.

• Receive, evaluate, and process medical device test articles for testing, ranging from simple solid materials to complex implants, tubing sets, syringes, and plastic components.
• Determine the appropriate testing and preparation needed for each device upon receipt, ensuring all instructions and documentation are complete and accurate.
• Calculate surface area and extraction ratios for medical devices, including complex configurations such as tubing sets where certain components (e.g., end caps) must be excluded if they will not contact patients.
• Prepare device extractions and dosing solutions according to ISO requirements, standard operating procedures, and study protocols using aseptic technique.
• Perform sample preparation and extraction of medical devices into appropriate liquids for subsequent dosing in animal studies.
• Communicate and coordinate sample preparation, scheduling, and priorities with scientific staff and Study Directors to meet project timelines.
• Run assays, read slides, and perform in vitro work including cell culture and use of fluorescence microscopy, as required by study protocols.
• Conduct dosing studies in the vivarium, including taking body weights of animals, administering test articles (such as via single injections), and observing animals as specified in the protocol.
• Participate in reporting study results and documenting testing and assay outcomes in a clear and accurate manner.
• Maintain meticulous, precise, and contemporaneous records of all preparations and laboratory activities in accordance with GLP requirements.
• Follow detailed instructions and study protocols, performing basic mathematical calculations accurately for dosing, dilutions, and extraction ratios.
• Maintain a clean, organized, and compliant work area, including cage wash and general laboratory cleanliness tasks as needed.
• Adhere to all safety requirements, including the ability to safely wear a respirator when necessary.
• Lead and mentor less experienced personnel, providing training on device preparation, extraction practices, and GLP-compliant documentation.
• Adapt to a fast-paced environment where schedules and priorities may change based on client needs, while working independently and proactively seeking guidance when necessary.

• Direct hands‑on CRO experience preparing extracts of medical devices for testing.
• Practical experience handling a variety of medical devices, including solid materials, implants, tubing sets, syringes, and plastic components, for extraction and testing.
• Strong working knowledge of ISO requirements relevant to medical device extraction and testing.
• 25 years of experience working under GLP conditions, specifically in in vitro toxicology or related genetic toxicology studies (e.g., mouse toxicology).
• Experience preparing device extractions for in vivo dosing, including calculating surface areas and extraction ratios and preparing solutions for animal administration.
• Background in toxicology, including dosing procedures and intravenous or related administration techniques.
• Experience…