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Biocon i
s an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries.Job Title : Associate Scientific Manager – Toxicology
Eligiblity : Ph.D – Biomedical, Biotechnology, Bio-Chemistry/Bio-Technology
Experience : 5 – 8 Years
Location : Bengaluru/Bangalore
No of Openings : 1
Job Description :
- Designing and supervising of toxicology studies conducted in various laboratory animals
- Types of studies include impurity qualification, battery of genotoxicity assays, MABEL acute, subacute, subchronic and chronic toxicity and cross reactivity studies.
- Toxicological evaluation and Safety assessment (Calculation of ADI, PDE, PEL, OEL etc.,) of Raw materials, intermediaries, metabolites and finished products for small molecule generics and excipients.
- Auditing preclinical CROs in India and US for their technical competency and animal welfare and Monitoring study activities (Critical Phases).
- Supporting documentation, presenting the toxicology data, addressing any technical queries and preparation for Due Diligences.
- Managing various internal and collaborative projects in the function of Project Manager (Timeline, resource and man power planning).
- Meeting RCGM and DCGI (Indian Regulatory bodies) on regular basis for preclinical protocol approvals and presentation.
- Preparation and review of Non-clinical sections for regulatory submissions such as BLA, IND and ANDA.
- Preparing justification and providing technical expertise report on regulatory queries on Drug substance and Drug Product Safety.
