Hitesh Sharma
Manager at Cipla
Management
Cipla
India
Biography
Experience in handling Raw material/ packing material & biochemistry section in a leading role. Analytical Method Validation, optimization, & method qualification in the biochemical and instrumentation sections. • To review and execute all technology transfer related activities and analytical method validations in QC. • Equipment Qualifications (DQ, IQ, OQ, PQ, PV) of all the equipments related to the biochemical, stability and Instrumentation sections • Performed various laboratory techniques such as Immunochemical and Biochemical techniques to study protein expression, DNA / RNA Extraction from tissue and body fluids, mononuclear cell separation, PCR and RT- PCR Amplification techniques and Agarose Gel electrophoresis for separation nucleic acid. • Perform HPLC assays of the recombinant Bio molecules for batch release, analytical method validation, other testing activities and related documentation as per STPs and approved protocols. • Compiling records, interpreting analytical results, maintaining laboratory data and developing corrective action plans to address quality issues. • Qualify, Operate, calibrate and maintain laboratory equipment, apparatus and maintain service logbooks. • To maintain required documentation, data entry, updating procedures and compile reports as required. • Preparation and revision of STPs, SOP, MOA and related documents as and when required. • Impart training on different tests to new employees & student trainees.
Research Interest
Specialties: Analytical method optimization and validation. Stability studies of biotherapeutic proteins. Planning and Execution of MAbs, rHu GCSF, PEG –rHu GCSF, and rHu EPO and rHu PTH. Excellent knownledge in characterization techniques for biotherapeutics like SDS PAGE,Westren blotting,ELISA,PCR,Chromatography,IEF etc. Strong knownledge of regulatory guidelines.
