Job Description

Job title: Senior Lead Scientist -Developmental and Reproductive Toxicology

Job location: Bangalore

Department: Safety Assessment

About syngene: syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and sops, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role:

As a Study Director - Developmental and Reproductive Toxicology (DART), you will serve as the single point of control and overall scientific authority for the planning, conduct, interpretation, and reporting of developmental and reproductive toxicity studies conducted in compliance with GLP, applicable regulatory requirements, and study plans. You will provide scientific leadership in the design and execution of fertility, embryo-fetal development, pre- and postnatal development, and/or other reproductive toxicology studies supporting the nonclinical safety assessment of pharmaceuticals, biotechnology products, chemicals, agrochemicals, and specialty products. You will be responsible for ensuring study quality, data integrity, regulatory compliance, client engagement, timeline adherence, and the delivery of scientifically robust reports that support global regulatory submissions and informed decision-making by sponsors.

Role Accountabilities:

Study Direction & Scientific Leadership

• Serve as the designated Study Director for GLP-compliant Developmental and Reproductive Toxicology (DART) studies, with overall responsibility for study conduct, scientific integrity, and regulatory compliance.
• Design study plans, amendments, schedules, and data collection strategies in accordance with applicable regulatory guidelines and sponsor requirements.
• Provide scientific oversight for fertility, embryo-fetal development, pre- and postnatal development, and other reproductive toxicity studies.
• Interpret study findings and assess toxicological relevance, adversity, NOAELs, target organ effects, developmental toxicity, reproductive toxicity, and risk implications.

Regulatory & Quality Compliance

• Ensure studies are conducted in compliance with GLP principles, institutional SOPs, animal welfare regulations, and applicable international regulatory guidelines.
• Act as the single point of study control and ensure the accuracy, completeness, traceability, and integrity of study data.
• Address quality assurance observations, deviations, study plan amendments, and corrective and preventive actions (CAPA) in a timely manner.
• Support regulatory inspections, sponsor audits, and internal quality audits.

Study Execution & Oversight

• Coordinate with multidisciplinary teams including animal facility, veterinary, pathology, bioanalytical, toxicokinetic, and quality assurance functions to ensure seamless study execution.
• Monitor study progress, resource utilization, timelines, and milestone achievement to ensure on-time delivery.
• Review in-life, laboratory, pathology, and toxicokinetic data for scientific accuracy and consistency.
• Ensure appropriate evaluation and integration of toxicokinetic and exposure data into study interpretations.

Reporting & Scientific Communication

• Prepare, review, and approve study plans, final reports.
• Provide high-quality scientific support during sponsor discussions, audits, and regulatory interactions.

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

Experience

• PhD/MVSc in Toxicology, Veterinary Pharmacology, Animal Reproduction, Laboratory Animal Medicine, or a related life sciences discipline.
• Typically 5+ years of relevant experience in nonclinical safety assessment, with substantial hands-on experience in Developmental and Reproductive Toxicology (DART) studies.
• Demonstrated experience as a Study Director, Principal Investigator, or study personnel for GLP-compliant reproductive and developmental toxicity studies.
• Experience interacting with global pharmaceutical, biotechnology, agrochemical, or specialty chemical sponsors.
• Familiarity with regulatory inspections and client audits.

Technical Knowledge

• Strong understanding of reproductive physiology, developmental biology, teratology, reproductive pathology, endocrinology, and toxicology.
• Thorough knowledge of international regulatory guidelines including ICH S5(R3), OECD, and other relevant reproductive toxicity testing requirements.
• Expertise in study design, dose selection, toxicokinetic interpretation, data evaluation, and risk assessment.
• Sound understanding of GLP regulations, animal welfare requirements, AAALAC principles, and the 3Rs (Replacement, Reduction, and Refinement).
• Working knowledge of related disciplines including pathology, toxicokinetics, bioanalysis, and statistics.

Skills & Capabilities

• Strong scientific interpretation and technical report-writing skills.
• Ability to critically evaluate reproductive and developmental safety data and provide scientifically sound conclusions.
• Excellent project management, organization, and study coordination capabilities.
• Effective stakeholder management and client communication skills.
• Strong problem-solving, decision-making, and risk assessment abilities.
• Ability to lead multidisciplinary teams in a fast-paced CRO environment.
• High level of attention to detail, data integrity, and regulatory compliance.
• Strong presentation skills for sponsor meetings, audits, and scientific forums.

Education

• MVSc or Msc or M. Pharm with significant DART experience; or
• PhD in Toxicology, Reproductive Biology, Veterinary Sciences, Pharmacology, or a related field

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.