Group Lead Invivo and Invitro

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