Job Description

Department Details
Role Summary

• Contribute towards the design of end-to-end analytical strategies to support biosimilar product development, manage day to day analytical requirements with respect to separations (chromatography and electrophoresis), spectrophotometry, higher order structure, mass spectrometry etc. Participate and lead analytical efforts towards process analytical support, process characterization, inter-lab method transfer activities and provide inputs for validation activities
• Design protein characterization strategies for biopharmaceuticals such as monoclonal antibodies and fusion proteins, using advanced mass spectrometric and higher order structure tools. Keep abreast of the latest scientific and technical updates pertinent to project deliverables and plan experimentation accordingly. Design the use of appropriate controls to prove the scientific soundness of the testing tools. develop strategies to establish structure-function relationship.
• Design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CE-MS, CEX-MS, SEC-MS.
• Design advanced workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, cell culture metabolite analysis, glycan analysis etc
• Ensure data traceability and GDP (procedure, controls, analysis and observation of the experiments) in electronic laboratory notebook. Serve as a power user in acquisition/analysis software and create protocol/ templates in processing software to effectively automate the process of testing. Regularly review trend charts and provide technical inputs. Review technical documents such as MDR, MQP, MQR, IOP, EOP etc. Review quality documents such as change controls and deviations etc
• Propose and monitor laboratory expenditure, manage inventory of critical reagents and consumables, co-ordinate with cross functional teams for procurement, manage equipment/instrument allocation, co-ordinate with instrumentation team for maintenance.

Key Responsibilities

• Contribute towards the design of end-to-end analytical strategies to support biosimilar product development, manage day to day analytical requirements with respect to separations (chromatography and electrophoresis), spectrophotometry, higher order structure, mass spectrometry etc. Participate and lead analytical efforts towards process analytical support, process characterization, inter-lab method transfer activities and provide inputs for validation activities
• Design protein characterization strategies for biopharmaceuticals such as monoclonal antibodies and fusion proteins, using advanced mass spectrometric and higher order structure tools. Keep abreast of the latest scientific and technical updates pertinent to project deliverables and plan experimentation accordingly. Design the use of appropriate controls to prove the scientific soundness of the testing tools. develop strategies to establish structure-function relationship.
• Design and implement integrated strategies, linking appropriate chromatography and mass spectrometry tools, to perform a qualitative and quantitative assessment of product related variants and impurities. Develop and apply novel sample preparation with emphasis on LC-MS, CE-MS, CEX-MS, SEC-MS.
• Design advanced workflows such as multi-attribute methods for PTMs, sequence variants, qualitative and quantitative profiling of HCPs, cell culture metabolite analysis, glycan analysis etc
• Ensure data traceability and GDP (procedure, controls, analysis and observation of the experiments) in electronic laboratory notebook. Serve as a power user in acquisition/analysis software and create protocol/ templates in processing software to effectively automate the process of testing. Regularly review trend charts and provide technical inputs. Review technical documents such as MDR, MQP, MQR, IOP, EOP etc. Review quality documents such as change controls and deviations etc
• Propose and monitor laboratory expenditure, manage inventory of critical reagents and consumables, co-ordinate with cross functional teams for procurement, manage equipment/instrument allocation, co-ordinate with instrumentation team for maintenance.

Educational Qualifications
Required Education Qualification: MS
Required Experience: 10 - 15 years