Overview

The ClearPoint Neuro, Inc. Biologics & Drug Delivery (B & DD) team is dedicated to bringing transformative therapeutics from the laboratory bench to the clinic so that they may improve the lives of patients and their families. In collaboration with our partners, we complete nonclinical investigations and submit Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications to the FDA that enable the initiation of first-in-human clinical trials. Our group is composed of highly trained veterinary, engineering, and scientific professionals capable of overseeing and completing a variety of nonclinical animal studies. Our operations are compliant with the FDA’s current Good Laboratory Practice (cGLP) regulations and other standards and guidelines applicable to completing animal studies.

This role contributes to the day-to-day operations of the B & DD team, with a primary responsibility to complete, with guidance from their supervisor or supervisor’s designee, advanced veterinary care procedures as directed by B & DD senior leadership and study-related activities using current Good Documentation Practices (cGDP) while maintaining compliance with cGLP regulations, ClearPoint Neuro, Inc., SOPs, sponsor-approved study protocol parameters, and other regulatory standards and guidelines.

Job Responsibilities

• Demonstrates knowledge and application of anesthesia and aseptic techniques.
• Set up and break down operating room and surgical cases.
• Demonstrates proficiency or knowledge of biological sample collection techniques.
• Performs study-related animal procedure planning and preparation
• Performs study-related animal procedures, including, but not limited to, specimen collection, in-life biological sample collection, surgery and surgical anesthesia management/support, and necropsy
• Performs regular animal health and wellbeing checks
• Maintains documentation of veterinary care and study-related procedures in a GLP-compliant manner and according to facility SOPs
• Enters raw study data in a GLP-compliant manner
• Manages receipt and transfer of research animals as needed
• Practices animal restraint and drug administration according to facility SOPs as assigned
• Develops, manages, and documents environmental enrichment practices in a GLP-compliant manner as needed
• Tracks and manages services, time, and supplies used for studies and accurately billing customers in a time-efficient manner
• Manages breeding, strain maintenance, genotyping and identification systems of multiple colonies of rodents for multiple research groups simultaneously
• Manages large supply inventories efficiently
• Understands, follows, collaborates, and carries out all facility SOPs, quality assurance standards, safety procedures, and documentation requirements for study procedure activities, colony management activities, animal enrichment activities.
• Plans and executes animal research study procedures, including, but not limited to, drug administration, surgery, surgical anesthesia, necropsy and biological sample collection in a GLP-compliant manner.
• Conducts detailed large and small animal necropsy with fine attention to detail, while maintaining GLP-compliant documentation.
• Using excellent record-keeping, tracks time and supplies used in study-related procedures and bills customers efficiently and completely.
• Other responsibilities as assigned by supervisor.

Education, Licenses, Certifications, & Registrations

• Required Education: HS diploma or GED
• Preferred Education: Associate degree or higher
• Required Experience: Previous experience in a laboratory animal setting and demonstrated knowledge of the full scope of laboratory animal care
• Preferred Experience: Previous experience working with nonhuman primates and other large animal models; one year of experience working in a GLP-compliant animal facility
• Preferred Licenses/Certificates/Registrations: Registered Assistant Laboratory Animal Technician (RALAT)

Additional Technical Requirements

• Excellent self-motivation with providing animal care according to SOPs
• Excellent oral communication skills
• Excellent record-keeping ability
• Basic anesthesia in rodent and large animal species
• Ability to comprehend and use medical record-keeping system

About ClearPoint Neuro, Inc.

ClearPoint Neuro, Inc. is a neurosurgical device company. Our Biologics & Drug Delivery (B & DD) team partners with numerous pharmaceutical companies developing novel gene therapy, cell therapy, and neuro-oncolytic products that require novel routes of administration directly into the central nervous system.

Connections working at ClearPoint Neuro, Inc.