GLP Study Director - In Vivo Services bei Pacific BioLabs

Description

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.

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.
• Prefer a minimum of 5-6 years of related experience. Applicants with 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.
• Must have 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.
• Exhibits strong technical skills and the ability to critically evaluate raw data and results with minimal supervision.
• Excellent written, reporting, and verbal communication skills and attention to detail.
• Must be able to sit and/or stand for extended periods of time.
• Must be able to work with persons of diverse background.
• Proficient in using Microsoft Office including Word, Excel, and Power Point.
• Must be highly motivated and capable of working independently or under minimum supervision to deliver results under tight deadlines.
• Able to lift 10 – 25 pounds.

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 also may vary depending on the candidate’s job-related knowledge, skills, and experience among other factors. This position will be eligible for medical, dental, vision, life insurance, 401k, and other benefits.

PBL is an equal opportunity employer committed to diversity and inclusion. PBL considers all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans’ status, or any other legally protected factors.