GLP Study Director - In Vivo Services

Pacific BioLabs is an independent CRO providing cGMP/GLP testing in toxicology, biocompatibility, pharmacology, analytical chemistry, and microbiology. We are currently hiring to support our clients in the pharmaceutical, biotech, and medical device fields. Join us in our mission to improve public health through science!

PBL has immediate openings for full time GLP Study Director in the In Vivo Services Department. As the single point of study management and control, GLP Study Director will be responsible for the overall conduct of GLP studies focused on medical devices and pharmaceutical products ensuring compliance with GLP regulations.

Responsibilities of the GLP Study Director include:

• Serve as the Study Director for a variety of biocompatibility, safety, and efficacy studies for medical devices and pharmaceutical products in accordance with Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies (Title 21, Part 58).
• Overall responsibility for the technical conduct of GLP studies that includes study design, protocol assembly, study amendment management, oversight of testing personnel, study execution, data interpretation and analysis, and reporting.
• Working proactively with Sponsors in developing protocols that follow PBL SOPs, GLPs, ISO, etc. and other applicable regulatory guidelines. Ensuring that any protocol changes are approved and documented in accordance with GLP practices.
• Working collaboratively with department management, veterinarian personnel, and Quality Assurance in exceeding Sponsor expectations in the conduct of studies.
• Serve as Multistudy Project Coordinator.
• Ability to review study data in all phases of study execution and direct oversight of completion of corrective actions, deviations, and CAPA generation and review.
• Ensure that unanticipated responses of study data are corrected, accurately recorded, verified, and documentation corrective actions are taken in accordance with regulatory guidelines.
• Oversee and manage subcontracted GLP testing with approved vendors and qualified Principal Investigator personnel.
• QC review of raw data for technical content and regulatory compliance.
• Managing applicable study deviation investigations.
• Collaboration with Business Development on Sponsor outreach and testing quotes.
• Maintaining a safe and orderly laboratory and ensuring compliance with all safety policies and practices.