Head-Pathology

Job Description

Job title: Assistant Director and Head

Job location: Bangalore

Department: Safety Assessment, Pathology

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:

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

Education

• MVSc or PhD in Veterinary Pathology.  Board certification in Veterinary or toxicologic pathology (DIBTP/DICVP). DABT certification is desirable.

  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.

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