SECTION HEAD- CLAB

JOB DESCRIPTION

Job Title: Section Head

Job Location: Translational and clinical research

Department: Central Laboratory

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: Serve as the authorized signatory for lab reports ensuring compliance with NABL and CAP requirements.

Role Accountabilities

• Authorize and provide expert consultations on the medical significance of clinical laboratory data.
• Interpret, correlate, and communicate laboratory findings to clients, sponsors, investigators, clinical staff, patients, and other stakeholders.
• Ensure compliance with regulatory and accreditation standards while liaising with agencies, administrative officials, and the medical community.
• Oversee implementation of the Quality Management Plan and Quality Policy.
• Implement risk identification and mitigation strategies across all laboratory operations.
• Identify training needs and provide educational programs for medical and laboratory staff.
• Oversee technical and scientific aspects of laboratory operations, including method selection, development, modification, and verification.
• Ensure accuracy and proper functioning of test systems; resolve technical issues and implement corrective actions.
• Participate in proficiency testing programs and monitor performance.
• Address complaints, requests, and suggestions from staff and users of laboratory services.
• Back up to the lab director for NABL and CAP requirements.
• Primarily responsible for release of reports ensuring TAT compliance.
• Authorized signatory for Central laboratory.
• Participating in advisory services related to scientific matters of CLAB

Leadership Capabilities

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience – 02-05 years post MD
2. Demonstrated Capability- Worked in a NABL or CAP accredited laboratory.

Experience : Served as an authorized signatory and Medical Biochemist in an accredited laboratory, managing technical and regulatory requirements in line with ISO 15189:2022.

Skills and Capabilities

• Proven expertise in clinical laboratory operations, medical biochemistry/pathology, and interpretation of laboratory results.
• Strong understanding of NABL, CAP, ISO 15189:2022, quality systems, regulatory compliance, and audit readiness.
• Ability to authorize reports, ensure scientific accuracy, and support timely report release within defined TAT.
• Competence in method selection, verification, validation, troubleshooting, and technical problem resolution.
• Skilled in risk assessment, proficiency testing, quality indicators, and continual improvement initiatives.
• Effective stakeholder communication with clinicians, sponsors, investigators, clients, regulatory bodies, and internal teams.
• Demonstrated leadership in training, mentoring, team supervision, and building a quality- and safety-focused laboratory culture.

Education : MD Biochemistry/ MD Lab medicine/ MD Pathology

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.