Biocon Research Limited Work Values

Daily Duties at Biocon Research Limited:

•Authored and Prepared the CMC section for various Biosimilar projects for FDA and EMA filings (IND, IMPD, NDA.MAA, supplements and amendments) •Prepared Annual reports for assigned projects. •Served as a Regulatory representative in project teams and provided regulatory support (strategy) for new products/therapies and modifications to the existing products. •Evaluated key issues for discussion and negotiated with Health authority experts to clarify questions. • Provided regulatory support for the implementation of filing strategies for emerging markets to expand the global footprint of the company. • Documented and maintained oral and written communications with global regulatory agencies.

What they like about Biocon Research Limited:

The social vibrance of a hiring firm is very important to you. Your ability to make and maintain friendships there is a critical part of your decision. You would likely be dissatisfied with a workplace that is quiet, cold, or otherwise not particularly social. When you investigate a new hiring company, ask recruiters, managers, and potential co-workers about the social life and opportunities there. This is especially important when you are relocating; moving dramatically alters your social sphere both inside and outside the workplace.

Tags

Regulatory submission, Regulatory Strategy, FDA/EMEA regulations, CTD and eCTD, CMC (Chemistry, Manufacturing and controls), Regulations related to Biologics manufacturing and testing, Regulatory Liaison, Document Review, Pre- and Post-approval, Style guides, Scientific advice, Dossiers (IMPD/IND), Biosimilar guidelines, Emerging market registration, Technical files, ICH guidelines, Clinical Trial application (CTA), Biologics, Interfacing, Recombinant protein expression systems (Fungal), Microbial culture/ growth (Bacterial and Fungal), Preparation, Handling, stability monitoring of the cell banks, Batch, Fed-batch process (Media/Feed preparation), Upstream process development, Optimization of Critical process parameters, Hands on experience on the use of lab scale Bioreactors, biosafety hoods, shake flasks, Protein analysis and characterization (HPLC, SDS-PAGE, Blue Staining and Silver staining, Western Blot, ELISA, UV-Spectroscopy, Densitometry analysis), Scale-up and GMP manufacturing, Membrane filtration (Micro-, Ultra-, and Dia-filtration), Process trouble shooting, Chromatography (RP-HPLC, SEC, GC, Ion Exchange chromatography), Analytical method development, Enzymatic assays, Downstream process and partial purification of proteins, Scientific Writing (Development reports, Strong communication and presentation skills, Excellent analytical, interpretational, problem solving skills, Can manage projects independently and in teams, Ardent reader of Scientific Journals and Research papers

Skills

Regulatory Filing, Regulatory compliance, ICH guidelines, Document Review, IMPD, Scientific writing, Regulatory Strategy, GLP, GMP, GCP, Fermentation , Bioprocess, Microbiology, Method development, Enzymatic assays, Technology transfer, Scale-up and Scale-down studies, Microsoft office, Microsoft Excel, Downstream process, documentation, Communication skills

These are some of the questions we asked our climbers about their experiences with Biocon Research Limited: