Job Description

The AIP technician is responsible for performing accurate, high quality necropsy/histology study work for rodent and non-rodent safety studies in compliance with the study protocol, Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP) regulations, Environmental Health and Safety (EHS) standards, animal welfare regulations, and departmental policies/procedures. The pathology data collected and processed on these studies by the Pathology Technician enable candidate selection, first-in-human studies, 13-week studies and early research and target safety and investigative work.

POSITION RESPONSIBILITIES

• Perform all regulatory responsibilities in compliance with applicable regulatory standards.

• Read, understand and follow the study protocol and understand connection between study

protocol and Pristima protocol which is based on the study protocol.

• Responsible for performing all aspects of the necropsy/histology phase of rodent and nonrodent

safety studies including study set up, necropsy, tissue trimming, processing, slide cutting, staining, data collection and documentation, data quality control review, and preparation of necropsy/histology data for archiving.

• Ensure proper supplies and equipment are available and suitable for study conduct functions; generate forms, labels, and other materials needed for study conduct as required.

• Completes self-review of necropsy/histology data for accuracy and completeness against

the protocol; appropriately documents and corrects data errors, notifies appropriate study personnel as required.

• Troubleshoot and solve equipment/technical problems associated with necropsy/histology components of study conduct.

• Communicate with Management, Study Director, Comparative Medicine and support personnel to ensure compliance with all protocol driven activities, high quality animal welfare practices are followed, and to enable proactive adjustment of the protocol by the Study Director in the event of unexpected events or findings.

ORGANIZATIONAL RELATIONSHIPS

• Pathology line, including Pathologists, Global AIP Lab Leader, DSRD AIP Laboratory Managers and AIP scientists and Technicians.

• Global Pathology Quality Control Team and Global Pathology Slide Scanning Lead

EDUCATION AND EXPERIENCE

Minimum

• ≥ 4 years applicable histology experience; or Associates degree, Biological Sciences (or equivalent) with HT (ASCP) with 2 years applicable histology experience; or B.S., Biological Sciences (or equivalent) with 1 year applicable histology experience.

Preferred:

• > 7 years applicable histology experience, or Associates degree, Biological Sciences (or equivalent) with >3 years of relevant necropsy and/ histology experience, HT (ASCP) certification or eligible

• B.S., Biological Sciences (or equivalent) with > 1 year of relevant necropsy and/or histology experience, HT (ASCP)

HT Certification preferred but not required

TECHNICAL SKILLS REQUIREMENTS

• Training in histology/necropsy and/or performing other laboratory techniques for in vivo

studies in multiple species (rat, mouse, dog, NHP) in a GLP environment

• Use of electronic data capture systems, spreadsheet applications or other data management

Systems

• • Performs effectively as a team member; accurately records data; effectively follows verbal and written instructions; maintains a positive work atmosphere; communicates effectively; and interacts in a professional manner with management, colleagues, and customer and partner groups.

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