DSRD In Vivo Tech Associate

ROLE SUMMARY

DSRD Study Enabling & Execution is a global group composed of subject matter experts in study and project execution, training, compliance and systems, who plays a critical role in the success of DSRD. As a highly valued partner, we focus on the development, empowerment, and leadership of our colleagues to ensure their growth and success.

The In Vivo Technician role functions within study execution and provides non-GLP and GLP in vivo study conduct expertise to advance the Pfizer portfolio, particularly for the selection of new therapeutic candidates but also for support of later stages of clinical development and registration.

The In Vivo Technician is responsible for performing accurate, high quality in-life 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 data collected on these studies by the In Vivo Technician enable candidate selection, first-in-human studies, 13-week or longer studies and early research and target safety and investigative work.

ROLE RESPONSIBILITIES

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

• Responsible for performing all aspects of the in-life phase of rodent and non-rodent safety studies including study set up, test article administration, animal observation, sample collection, data collection and documentation, data quality control review, and preparation of in-life data for archiving.

• Read, understand and follow the study protocol and understand connection between study protocol and the electronic data capture system protocol which is based on the study protocol.

• Serve as Study Technician for studies depending on level and experience.

• Manage multiple assignments/projects as assigned while maintaining data quality and meeting timelines.

• 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.

• Responsible for use, maintenance and calibration of equipment, e.g. balances, centrifuges.

• Troubleshoot and solve equipment/technical problems associated with in life 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.

• Completes self-review of in-life data for accuracy and completeness against the protocol; appropriately documents and corrects data errors, notifies appropriate study personnel as required.

• Completes QC review of in-life data collected by others depending on experience and level.

• Assist in preparing data for QA audits and addressing and drafting responses depending on level and experience.

• Adheres to all applicable company and unit policies and procedures.

• Ensures work areas are kept clean and orderly.

• Meets established timelines for deliverables.

• Reviews and recommends updates for departmental SOPs, may draft updates to SOPs depending on experience and level.

• Participates in a culture of continuous improvement within assigned work group.

• Other activities as delegated by Study Director or Test Facility Management.

QUALIFICATIONS

Must Have

• High school with 2 to 3 years applicable experience (i.e., veterinarian care, laboratory animal care and handling); or

• Associate's degree, Biological Sciences (or equivalent) with 1-3 years applicable experience

Nice to Have

• >7 yrs of relevant in vivo toxicology study conduct experience

• A.S., Biological Sciences (or equivalent) with > 3 yrs of relevant in vivo toxicology study conduct experience

• B.S., Biological Sciences (or equivalent) with > 1 yrs of relevant in vivo toxicology study conduct experience

• AALAS Certification

• GxP experience

PHYSICAL/MENTAL REQUIREMENTS

• The position requires performing in vivo work (working directly with laboratory animals) and therefore the colleagues must be able to wear appropriate PPE and physically perform the technical procedures. In addition, this position requires the entry into nonhuman primate areas as part of their