- 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:
The purpose of this role is to provide leadership and scientific guidance to the pathology group, and to serve as a study pathologist and peer reviewer for non-clinical safety studies. The role is responsible for planning, organizing, and directing the pathology phase of Safety Assessment projects, and for delivering high-quality reports to clients in compliance with Good Laboratory Practice (GLP) and regulatory requirements.
Role Accountabilities:
Scientific role
- Provide scientific leadership and expertise to guide pathologists and technical staff to conduct all activities related to pathology phase of preclinical toxicology projects
- Provide scientific leadership regarding the design and conduct of preclinical toxicology studies.
- Act as Study Pathologist for sub-acute, sub chronic, reproductive and carcinogenicity studies
- Act as Principal investigator for multisite projects
- Set high-quality standards for processes, methods and reporting of pathology results through recommendations and critical reviews as per international industry standards
- Hold self and peers accountable for achieving Pathology objectives.
- Conduct formal peer reviews of pathology studies
- Keep up to date on current trends in practice of industrial toxicologic pathology
- Review of pathology and toxicology study designs, study updates, SOPs and reports for accuracy, scientific correctness, quality, and regulatory compliance and provide constructive feedback.
- Address sponsor and regulatory queries with a detailed response with literature support.
Managerial role
- Set high standards with respect to processes and deliverables, while ensuring compliance with Good Laboratory Practice (GLP) and regulatory requirements
- Ensure pathology phase of the study is conducted with high quality and integrity, and meets international standards with respect to scientific soundness and accuracy
- Ensure completion of projects with high quality reports of international standards within the target date
- Manage multiple studies or projects and troubleshoot scientific and business-related issues
- Ensure the QUOTIFFs are met
- Ensure compliance with safety and quality
- Ensure change control/ SOP revision closure within time
- Training plan for junior pathologists and guiding them for IBTP certification
- Monitor key performance indicators for the year
- Process improvement and cost control through Kaizens
- Represent as pathology expert in client meetings
- Effectively handle inspections by regulatory agencies
Business development/Finance
- Continue to build relationships with existing customers for standalone histoprocessing and histopathology evaluation
- Foresee business opportunities in Pathology to achieve long-term goals.
People Management
- Maintaining a positive workplace culture through empowering and engaging staff.
- Actively participate in the performance management of pathology staff, recognize and reward.
- Involve in recruitment of right talent and develop them through coaching and training initiatives.
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
Experience
- 15+ years of collective pathology experience in safety evaluation studies and management of pathology lab in Pharmaceutical or contract research industry.
- Experience in pathology evaluation of various types of preclinical toxicology studies in rodents and non-rodents, including peer reviews.
- Experience in handling complex pathology studies
Skills and Capabilities:
- Fluent oral and written communication, presentation and management skills and scientific writing ability.
- Ability to manage multiple projects and troubleshoot scientific and business-related issues.
- Ability to make effective decisions to positively impact the goals of projects and functions.
- Ability to manage clinical and anatomic pathology labs, meet the quality standards and handle multiple projects simultaneously while adhering with timelines
