Assistant Director - Genetic toxicology

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies.

With over 30 years of GLP compliance and certification, Eurofins Advinus serves diverse industries such as Biotech, Pharmaceutical, Biological, Agrochemical, Nutraceutical and Cosmetic. Eurofins Advinus is the only contract research organization (CRO) in India to have developed data in support of 90+ end-to-end IND enabling packages to be submitted to global regulators such as USFDA, EMA, MHRA, Health Canada and others.

Experience (years)

20-22+ years relevant experience or PhD in Microbiology with at least 15+ years of relevant industry experience.

Job description:

• In-depth scientific expertise in Genotoxicology, with significant experience in designing, executing, and interpreting genetic toxicology studies in both regulatory (FDA, EMA, ICH, and OECD guidelines) and non-regulatory environments.
• Responsible for the execution, planning, performance, reporting/archiving, and management of studies such as the Bacterial Reverse Mutation Test (Ames Test), Bone Marrow Micronucleus Test, Chromosome Aberration Test, and In Vitro Micronucleus Test etc.
• Preparation of study plans, protocols, amendments to study plans, study reports, creation, and review of SOPs.
• Lead and manage a team of genetic toxicologists, providing mentorship and guidance to achieve departmental and organizational objectives.
• Oversee study directors across multiple studies and ensure consistent performance.
• Train and onboard new staff, ensuring they meet expected proficiency levels for quality work in compliance with GLP standards.
• Prepare monthly forecasts and reports, and plan for the effective use of resources.
• Focus on maintaining strong client communication, ensuring timely delivery of services, and fostering repeat business.
• Oversee laboratory maintenance, equipment validation and calibration, and procurement of reagent supplies.
• Participate in GLP/NABL activities, inspections, and ensure adherence to regulatory compliance guidelines; address Quality Assurance checklists and GLP compliance.
• Collaborate with HOS/HOD in budgeting, costing, planning, and conducting studies, as well as in the development of new platforms and operational activities.
• Support to business development and marketing efforts, generate new business leads alongside the BD team.
•  Standardize and implement new in vitro test procedures.

Qualifications / Skills Required:

• Masters in Microbiology (M.V.Sc / M.Sc) with at least 20-22+ years of relevant industry experience or PhD in Microbiology with at least 15+ years of relevant industry experience
• Understanding of the agrochemical and pharmaceutical R&D process
• Strong problem-solving skills and the ability to develop innovative solutions.
• Experience in managing internal and external collaborations.
• Willingness to adapt to rapidly changing scientific and regulatory environments.
• Effective team collaboration skills to achieve project goals, objectives, and deadlines.

Behavioral Competencies:

• Strong oral and written communication skills.
• Ability to adapt and work efficiently in a dynamic environment.
• Excellent time management skills to effectively handle multiple projects.
• Highly motivated, takes responsibility for personal improvement, learning from experience and new situations.
• Strong training, presentation, analytical, and computer skills
• Thinks of and/or encourages new ideas and keen to experiment and see ideas implemented.

Qualification

M.V.Sc / M.Sc. in Microbiology /

PhD in Microbiology