Analytical Expert

Dr Reddy's Labs Limited, IPDO, 

Key Responsibilities/Personal attributes.

• Guide the team in designing experiments on appropriate analytical techniques which are suitable and adequate for product development.
• Evaluate and use orthogonal approaches to resolve a problem and investigate the cause.
• Designing, planning and execution of formulation analytical activities for routine, stability sample analysis.
• Support for analytical method development and validation followed by analytical method transfer to plant location.
• Preparation of plant STP and specification to enable the exhibit batches analysis at plant.
• Review analytical data generated on different analytical techniques for completeness and it’s adequacy.
• Preparing the development reports and organizing the data required for technology transfer team/validation.
• Coordination with R&D and providing analytical support as per the project requirement. Analysis of results and discussion with the formulation team during the product development and filing.
• Good knowledge in impurity structure characterization using LCMS, GCMS, NMR etc.
• Good knowledge in Genotoxic impurities and Nitrosamine impurities assessment and method development.
• Good knowledge in Extractable and leachable study protocol design and execution as per regulatory requirement.
• Good knowledge in spray characterization study for nasal products.
• Interaction with RA for filing requirements. Providing required data to regulatory and quality of respective plants in support of executing the project at plant and filing.
• Good knowledge on different market regulatory requirements. Good understanding in regulatory query response writing.
• Coordination with plant QC/QA for OOT/OOS investigation and resolution.
• Coordination with SCM & FR&D for getting the excipients and planning for analysis.
• Identify the training needs of the team and implement an effective training calendar for all the team members.
• Experience of generic product development for Emerging market (China, Russia, CIS countries, Brazil) and Domestic (India) market.
• Good communication and coordination skills and ability to work with diverse cross-functional teams within IPDO and  FTO’s/CTO’s.

M.Pharm - 15-18 years/ PhD - 12-15 years/ M.Sc - 18-20 Years. 

1) Knowledge on Nitrosamine. elemental impurities analysis.

2) Team management skills

3) Should have experience to manage 10-15 scientists. 

4) Good in communication skills.