GLP Study Director, In Vivo Services

About the role

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

We have immediate openings for a full-time GLP Study Director in the In Vivo Services Department. As the single point of study management and control, the 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

• 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).
• Take overall responsibility for the technical conduct of GLP studies, including study design, protocol assembly, study amendment management, oversight of testing personnel, study execution, data interpretation and analysis, and reporting.
• Work proactively with Sponsors to develop protocols that follow PBL SOPs, GLPs, ISO, and other applicable regulatory guidelines. Ensure protocol changes are approved and documented in accordance with GLP practices.
• Collaborate with department management, veterinarian personnel, and Quality Assurance to exceed Sponsor expectations in study conduct.
• Serve as Multistudy Project Coordinator.
• Review study data in all phases of study execution and direct oversight of corrective actions, deviations, and CAPA generation and review.
• Ensure unanticipated responses of study data are corrected, accurately recorded, verified, and documented in accordance with regulatory guidelines.
• Oversee and manage subcontracted GLP testing with approved vendors and qualified Principal Investigator personnel.
• Perform QC review of raw data for technical content and regulatory compliance.
• Manage applicable study deviation investigations.
• Collaborate with Business Development on Sponsor outreach and testing quotes.
• Maintain a safe and orderly laboratory and ensure compliance with all safety policies and practices.

Requirements

• Bachelor’s Degree (B.S./B.A.) or equivalent in a scientifically related discipline. Related Master’s Degree (M.S./M.A.) or Ph.D. preferred. Applicants with AALAS certification highly desired.
• Minimum of 5-6 years of related experience. CRO experience highly desired.
• Broad understanding of GLP policies and regulatory requirements (FDA, CDC, USDA) highly desired. A combination of related experience and knowledge may substitute for education and experience.
• Demonstrated knowledge of laboratory animal science, toxicology, and histology.
• Ability to handle multiple projects of varying complexity and duration, prioritize work, and meet Sponsor deadlines.
• Strong technical skills and the ability to critically evaluate raw data and results with minimal supervision.
• Excellent written, reporting, and verbal communication skills with strong attention to detail.
• Ability to sit and/or stand for extended periods of time.
• Ability to work with persons of diverse backgrounds.
• Proficient in using Microsoft Office (Word, Excel, PowerPoint).
• Highly motivated and capable of working independently or under minimum supervision to deliver results under tight deadlines.
• Able to lift 10–25 pounds.

Pay

The pay range for this position is $120,000 to $150,000 per year. The base pay offered will take into account internal equity and may vary depending on the candidate’s job-related knowledge, skills, and experience.

Benefits

• Medical, dental, and vision insurance
• Life insurance
• 401k