Study Director -In-vivo Toxicology Syngene

3.0 - 8.0 years

4 - 8 Lacs

Bengaluru

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Core Purpose of the Role: As a Study Director - Toxicology: Responsible for ensuring that GLP toxicology studies; acute, repeat dose and reproduction are carried out to the required scientific and regulatory standards as per Global regulatory guidelines [ICH/OECD]. Function as single point of study control, overall responsibility for the scientific, technical and regulatory conduct of studies, scientific interpretation, documentation and reporting of results. Role Accountabilities: Study Director for in vivo toxicology studies Coordination with local cross-functional teams like veterinary science, biopharmaceutics, bioanalysis, pharmacokinetics or in vitro biology before, during and after execution of toxicology studies Conduct of in-life phases of toxicology studies in rats, mice and rabbits Dose administration in rats, mice and rabbits with various routes of administration Use of on-line data capture system- Pristima Blood sample collection for toxicokinetic Assistance during necropsy activities such as organ weighing, data entry in PROVANTIS software Assistance in conducting rabbit electrophysiology studies Coordination with veterinary science team IAEC meetings- preparation and maintenance of FORM-B and FORM-D Blood collection in rats and mice via different routes for clinical pathology analyses Preparation and following of in-house SOPs Co-ordination for preventive maintenance and calibration of instruments. Archival of materials from toxicology studies. Any other duties given from time to time by the line manager

Posted 3 weeks ago

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Senior Executive / Assistant Manager - IVIVC AET Laboratories

5.0 - 10.0 years

9 - 17 Lacs

Hyderabad

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Job Responsibilities : Develop and validate IVIVC and PBPK models to predict in vivo drug performance from in vitro data. Conduct in vitro experiments such as solubility, dissolution, and permeability studies using biorelevant media. Collaborate with formulation, analytical, and clinical teams to optimize drug product development. Analyze bioequivalence (BE) study data and support regulatory submissions with modeling insights. Prepare and review technical reports, protocols, and regulatory documentation . Preferred candidate profile & Qualifications: Should be well versed with IVIVC concepts,preferably 5-10 years of experience. Should have excellent knowledge on product development and clinical studies. Should have hands on experience on operating various simulation tools necessary for IVIVC. Excellent communication skills are must. Strong knowledge of oral solid dosage forms (OSDs) and excipient functionality. Experience with regulatory guidelines (e.g., USFDA, EMA) related to IVIVC and BE studies. M.Pharm or Ph.D. in Pharmaceutics, Biopharmaceutics, or Pharmaceutical Sciences.

Posted 1 month ago

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