Biologics- Analytical

Will work in Analytical development Lab of BRL. Responsible for analytical deliverables of Biologics Projects for regulated markets.

Deliverables involves but not limited to Method Development, Qualification, Technology transfer, Biosimilarity assessment, Forced degradation and Characterization activities.

Responsible for Independent planning and execution of experiments. Techniques include but not limited to Chromatography, Electrophoresis, Spectrophotometry and Colorimetric assays for Biotherapeutics.

Major responsibility will be planning and execution of HPLC, UPLC and CE based analysis

Skill sets:

Knowledge and hands-on experience of different chromatography modes like RP, HIC, IEX, SEC, etc is required.

Knowledge and hands-on experience of different capillary electrophoresis techniques cIEF, CZE, CE- SDS, etc. is required.

Hands-on experience in HPLC and UPLC is mandatory

Hands on experience of specialized techniques like N-Glycan analysis, Sialic acid analysis, Peptide mapping and amino acid analysis is an added advantage.

Hands on experience of Higher order structure analysis (DSC, CD, Fluorescence, FTIR, etc) is an advantage.

Competency:

Experience of working on biotherapeutic proteins like monoclonal antibodies or any candidate biosimilars is required.

Method Development and Qualification experience is must.

Understanding of analytical deliverables involving CQA, QTPP, Analytical similarity, Forced degradation studies, Specifications setting, etc. is preferred.

Accountability:

To perform assigned analytical activities by following established systems and procedures.

To maintain target dates for analytical activities.

To maintain data integrity during analysis.

Preparation and review of reports and contribution in troubleshooting efforts required for

instrumentation.

Communicate effectively with other team members and teams regarding the analytical data.