Study Director: GLP Regulated Lab Leader

Actalent; South Brunswick (NJ); Remote; USD 57,000 - 81,000; Full time

Job summary

Actalent is seeking a Study Director to lead GLP-regulated toxicology studies in a contract research lab. The role blends hands-on science with study design, data interpretation, and reporting, while ensuring EPA, FDA, DOT, OECD, and ISO standards are met.

You will mentor staff, manage sponsor communications, and maintain strict documentation. The position is based in a fast-paced environment in DAYTON, NJ, with a focus on cancer research using animal models.

Qualifications

• Bachelor of Science degree in a relevant field or equivalent experience.
• Hands-on laboratory experience in toxicology or related assays.
• Familiarity with GLP, EPA, FDA, ISO standards.

Responsibilities

• Supervise regulatory studies and provide day-to-day oversight.
• Develop and implement study protocols ensuring scientific rigor and compliance.
• Establish SOPs and test protocols for responsible studies.
• Design experiments and supervise execution with hands-on involvement.
• Obtain sponsor approval and manage protocol deviations as needed.
• Record, verify, and document all data and observations.
• Ensure tests follow approved protocols and regulatory guidelines.
• Prepare technical study reports for sponsors and internal teams.
• Communicate with sponsors and coordinate with cross-functional teams.
• Oversee lab operations and supervision of technical staff.
• Schedule studies and adapt to changing client priorities.
• Mentor less experienced staff and promote best practices.
• Run assays including gene toxicity and related tests.

Skills

GLP knowledge

Animal handling

Leadership

Regulatory compliance

Data reporting

Education

Bachelor of Science in toxicology or related field

Tools

PCR

Cell culture

Job description

Actalent is seeking a Study Director to lead GLP-regulated toxicology studies in a contract research lab. The role blends hands-on science with study design, data interpretation, and reporting, while ensuring EPA, FDA, DOT, OECD, and ISO standards are met.

You will mentor staff, manage sponsor communications, and maintain strict documentation. The position is based in a fast-paced environment in DAYTON, NJ, with a focus on cancer research using animal models.