Group Lead Invivo and Invitro

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