Group Lead Invivo and Invitro

Cipla; Pune District; On-site; INR 2,800,000 - 4,200,000; Full time

Job summary

Sitec Labs is seeking a Group Leader Invitro Vivo to head the preclinical and toxicology function at the Pune site, ensuring OECD GLP compliance and timely study delivery. You will oversee instrument validation (IQ/OQ/PQ) and lead in vivo/in vitro pharmacology, toxicology and PK studies per regulatory guidelines.

You will review SOPs, manage CAPA processes, coordinate with CROs, and mentor staff to ensure GMP/GLP readiness and data integrity across all studies.

Qualifications

• 10–12 years of experience in pharmacology, toxicology and pharmacokinetics within pharma/CRO/biotech.
• Strong understanding of OECD GLP, ICH, USFDA, EMA, CFDA/DCGI regulatory guidelines.
• Excellent communication for cross-functional collaboration and regulatory interactions.

Responsibilities

• Lead in vivo and in vitro preclinical and toxicology to ensure OECD GLP compliance.
• Ensure timely schedules and delivery of studies.
• Conduct IQ, OQ and PQ of instruments and maintain GLP systems.
• Design in vivo/in vitro pharmacology, toxicology, PK studies per guidelines.
• Prepare/Review SOPs to ensure GLP, including calibration and maintenance.
• Review study plans, raw data and reports for accuracy and compliance.
• Coordinate with external CROs for non-rodent studies.
• Ensure staff training, resources and system access.
• Address non-compliance with CAPA plan approvals and monitoring.
• Establish and monitor in vivo studies in rodents, rabbits, guinea pigs as per ICH/OECD.

Skills

Leadership

Regulatory knowledge

Communication

Project planning

Education

Advanced degree in Toxicology/Pharmacology/Zoology/Veterinary Science or related field

Job description

We are currently hiring a Group Leader Invitro Vivo at Sitec Labs in Pune which is Ciplas Subsidiary.

Sitec Labs (a Cipla subsidiary) is establishing a Preclinical & Toxicology Research Laboratory as a Contract Research Organization (CRO).

Key Responsibilities

• Establish, lead, and oversee the in vivo and invitro preclinical and toxicology function to ensure OECD GLP compliance for preclinical CRO.
• Ensure timely schedules and delivery of studies.
• Conduct the IQ, OQ and PQ of all instruments and ensure the GLP compliance
• Design and strategize in vivo and invitro pharmacology, toxicology, biocompatibility, and pharmacokinetic studies according to regulatory guidelines and sponsor requirements.
• Prepare and review SOPs to ensure GLP compliance, including management of SOPs, change control, calibration, and maintenance of equipment, instruments, and IT systems.
• Review and finalize study plans, raw data, and study reports for accuracy and GLP/regulatory compliance.
• Evaluate, monitor, and maintain computerized systems used for study data generation.
• Establish and monitor in vivo studies in rodents, rabbits, and guinea pigs as per ICH and OECD guidelines.
• Coordinate with external CROs for partnered studies in non-rodent species.
• Resolve non-compliant situations promptly, including CAPA plan approvals and monitoring.
• Ensure staff have adequate training, resources, and system access.

Qualifications and Skills

• Advanced degree in Toxicology, Pharmacology, Zoology, Veterinary Science, or a related field.
• 10-12 years of experience in pharmacology, toxicology and pharmacokinetics within the pharmaceutical, CRO, or biotechnology industry.
• Strong understanding of regulatory guidelines (e.g., OECD GLP, ICH, USFDA, EMA, CFDA, DCGI) and experience with regulatory submissions.
• Excellent communication skills for cross-functional collaboration and interaction with regulatory agencies and inspection authorities.
• Detail-oriented with proactive planning abilities, strong analytical skills, effective timeline management, problem-solving capabilities, and excellent teamwork skills.

Operational details

• Location: Hadapsar, Pune
• Workday: 6 day per week