Study Director - In Vitro Genetic Toxicology

Study Director - In Vitro Genetic Toxicology

Hours: 37.5hrs per week
Location: Alderley Park, Cheshire
Role Type: Permanent role; full time

The role

We're looking for an experienced Study Director to oversee GLP-compliant in vitro genetic toxicology studies, with a focus on Ames tests. You'll ensure studies meet regulatory standards, troubleshoot challenges, and uphold scientific excellence. As a key team member, you'll stay ahead of scientific advancements, mentor new Study Directors, and contribute to method development and validation work. Leadership opportunities, including line management may also be in the future for this role.

About us

Gentronix is located at Alderley Park in the north-west UK. We are committed to helping our clients develop safer chemicals and medicines, using innovative screening platforms as well as GLP regulatory tests to detect hazard, to understand mode-of-action, and help manage risk.

Comprising a team of over 60 employees with a range of experiences from within the pharmaceutical, agrochemical and CRO industries, our team has extensive expertise in the fields of genetic and skin/ocular toxicology. Our ambition is to become the leading provider of predictive and preclinical toxicology products and services across a variety of industry sectors.

The benefits

• Company Pension Scheme 8% company contribution
• 25 days holiday plus Bank Holidays
• Private Medical Insurance
• Life assurance x2 salary
• Employee Assistance Programme (EAP)
• Retail discounts
• Mental Health Wellbeing platforms
• Financial Wellbeing
• Enhanced Maternity, Paternity Shared Parental and Adoption

Gentronix has a collaborative and supportive culture with plenty of opportunities for you to grow and succeed. We offer excellent training, personal development opportunities and routes for career progression across all our teams.

Your role

This is a varied role, as a Study Director the tasks involve the organisation, execution, management, and reporting of GLP-compliant in vitro genetic toxicology studies at Gentronix, which may include managing multisite components. Non-GLP studies will also be in the scope for this role. The main activities of the role will be:

• Develop and review study plans in accordance with GLP (Good Laboratory Practice) regulations and client requirements.
• Define study objectives, methodologies, and data analysis strategies.
• Coordinate with stakeholders to ensure the study design meets regulatory standards and scientific goals.
• Ensure that all study activities comply with GLP guidelines and relevant regulatory requirements.
• Oversee the preparation of study-related documentation, including study protocols, progress reports, and final reports.
• Manage the overall study, including resource allocation, timeline management, and coordination with various teams (e.g., laboratory, quality assurance).
• Monitor study progress and address any issues or deviations from the protocol.
• Oversee the collection, validation, and interpretation of study data.
• Analyse results and draw scientifically sound conclusions.
• When relevant, collaborate closely with analytical chemistry colleagues to ensure dose formulation analysis aspects of studies are conducted on time and to the relevant specifications.
• Mentor the study team, including scientists, technicians, and other personnel involved in the study.
• Facilitate effective communication among team members and with clients.
• Provide regular updates on study progress and outcomes.
• Implement and maintain quality control procedures to ensure the accuracy and reliability of study results. This may include taking on roles such as System Administrator, SOP Owner or Validated Spreadsheet Owner.
• Address questions and findings relating to your studies that arise within client or QA audits or MHRA inspections.
• Prepare detailed study reports, including methodology, results, conclusions, and other supporting documents.
• Ensure all documentation is complete, accurate, and compliant with regulatory requirements.
• Review and approve final reports and other supporting documents before submission to clients.

About you

We are looking for someone who can hit the ground running with this role and make an impact quickly. Therefore, we want someone who possesses the following:

• Bachelor's degree in life sciences (or equivalent qualification); advanced degree preferred.
• Sufficient experience working in a life sciences laboratory, ideally within a GLP-compliant environment.
• Extensive hands-on experience conducting genetic toxicology assays under GLP standards.
• Strong practical knowledge of GLP regulations, with in-depth experience in in vitro toxicology, or post-graduate research in genetic toxicology.
• Proven experience working in a Contract Research Organization (CRO) is highly desirable.
• Experience in the Ames test and in vitro Micronucleus assays.
• Demonstrated ability to work both independently and collaboratively in a team.
• Advanced IT skills, including proficiency in Microsoft Office and laboratory data management systems.

You may have previously held the title of Scientist or Senior Scientist.

Gentronix are an equal opportunities employer, and we value diversity and are strongly committed to providing equal employment opportunities for all employees and all applications for employment. Equal opportunities are the only acceptable way to conduct business, and we believe that the more inclusive our environments are, the better our work will be.

If you're interested in applying for this role, please email your CV to .