Analytical Development Lead

Job Summary :

We are seeking an experienced Analytical Sciences professional to lead a team of scientists and drive analytical strategy for biosimilar product development in the R&D Centre at Chennai. This role involves partnering with project leads and cross‑functional teams to deliver high‑quality analytical data, support regulatory submissions, and ensure smooth execution of laboratory operations. The ideal candidate brings strong expertise in chromatographic and electrophoretic methods, spectrophotometry, higher‑order structure characterization, and mass spectrometry, along with the ability to independently design experiments, analyze complex datasets, and troubleshoot technical challenges.

Key Responsibilities :

• Lead a team of Scientists and work with Project lead to achieve analytical deliverables within timelines, Contribute effectively towards presenting results and conclusions in cross-functional meetings. Contribute towards regulatory filing requirements of the project. Collaborate with other Functional Leads to streamline analytical procedures and operations across RND.
• 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
• 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
• 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.

Education & Required Experience:

• Post graduate Degree or a doctoral Degree in life sciences such as biology, biochemistry, biotechnology, analytical chemistry or closely related field
• MS/ MSc/ M. Tech with 8-12 years of industry experience or
• PhD with not more than 3 Years of industrial or relevant post doc experience

We are an Equal Opportunity Employer and welcome applicants of all backgrounds. All qualified candidates will receive consideration without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.