Nagi Yenumula

• Led a diverse team to enhance productivity and foster collaboration across departments.
• Independintely managed all laboratory functions and projects.
• Managed, motivated and coached members of Laboratory to achieve timelines and continuously improve their individual effectiveness in meeting business needs.
• Ensured adherence to regulatory compliance standards, minimizing risks and promoting safety.
• Engineered innovative analytical methods that improved the accuracy and efficiency of testing processes.
• Performed in-depth data analysis to support strategic decision-making and improve operational outcomes.
• Optimized existing processes to enhance efficiency and reduce waste, driving continuous improvement initiatives.
• executed OOS and OOT investigations in support of other departments by following regulatory guidances.
• Implemented corrective and preventive actions to improve and avoide re-occurance of quality problems.
• Coordinated and Performed method development for various forms of drug products and drug substances using differint advanced techniques and treditional methods.
• Prepared and reviewed technical documents, including method vlidation protocols, reports, method development reports, standard operation procedures, test methods, change controls.
• Coordinated and performed method valodations, method verifications and method transfers between the laboratories.
• Coordinated analytical instruments calibration and preventive maintenance.
• Maintaine and guidae the stability programme for drug products.
• Supported formulation development and transfer activities for on going projects.
• Oversee and ensure that all laboratory equipment qualifications, calibrations, and preventative maintenance programs are maintained.
• Ensure that the analytical procedures developed, reviewed, or established in the laboratory conform to current and appropriate scientific and regulatory standards are suitable for use for their intended purpose.
• Having excelent knowledge about FDA and ICH guidance.
• Participating and assesting in regulatory audits (FDA and customer)

· HPLC method development for Raw Materials, Process intermediates and

Finished products of the Active Pharmaceutical Ingredients (API) and New Molecular Entities (NME).

· Analysis and method development of raw materials and APIs by auto titrator, UV/Visible spectrophotometer, TLC (Thin Layer Chromatography), Polari meter, TGA (Thermo Gravimetric analysis) And DSC (Differential scanning calorimeter).

· Routine analysis and On-line reaction monitoring of the synthetic process.

.Perform method validations and method verifications.

· Chiral HPLC method development for finished products of bulk drugs.

· Long term and Accelerated stability testing of pharmaceuticals.

· Preparation and qualification of primary standards.

· Preparation of specifications, method of analysis for raw materials, process

Intermediates and Finished products.

· Impurities separation, enantiomers separation and isolation by preparative HPLC.

· Perform the calibration of the instrument as per the approved SOPs (standard Operating Procedures)

· Generating Stability data for the new drug substances as per ICH guidelines and Holding data.