Job Description

Department DetailsRole SummaryPost-graduate with 5-7 years of experience or PhD with up to 2 years of experience in biopharmaceutical industry. Life sciences background in biochemistry, biotechnology, protein chemistry or allied subjects preferred.Key ResponsibilitiesRelevant experience in biopharmaceutical industry in analytical method development/ qualification/ transfer, in-process/ stability sample testing, CQA assessment, biosimilarity analysis of monoclonal antibodies, insulin analogues, pegylated proteins, antibody-drug conjugates, therapeutic peptides. Experience in pharmaceutical industry (generics, complex generics, peptides) in chromatographic methods with strong foundation in analytical chemistry.
In-depth knowledge of various analytical technologies including chromatography (SEC, IEC, RP, HIC, HILIC), capillary electrophoresis (CGE, iCIEF, CZE) and spectroscopy (UV280, SoloVPE).
Independently design, execute and record experiments in electronic lab notebook (Labware-LIMS). Interpret and analyse data using relevant instrument software's (Empower, Chromeleon, 32 Karat, Compass for iCE) and disseminate results through reports, data presentations in team meetings. Able to troubleshoot critical issues and determine possible solutions.
Maintain instruments in coordination with operations team and support installation of new instrument. Keep track of ordering and maintaining inventory of consumables/ reagents and support in lab maintenance.
Familiarity with statistical tools (GraphPad Prism, JMP), Empower Method Validation Manager, Document Management System (DMS), Digital Quality Management Software (Trackwise) is desired.
Author or review documents including method development reports, protocols (qualification /transfer/ study) and reports (qualification /transfer/ study). Prepare operating procedures (IOP, EOP, SOP) and author change controls, deviation and CAPA
Work primarily as an individual contributor and train and cross-train colleagues towards experimental design, execution and troubleshooting, technical review of raw data.
Educational/ Industry Experience Required:Educational QualificationsRequired Education Qualification: MS
Required Experience: 8 - 15 years

Biocon