Kumar Bandi

As Assistant Director (Group leader)

Formulation Analytical Research & Development

Regulated markets USA and Europe

Leading a team of 10 scientists including 1 manager and 1 reviewer for all research and development related analytical activities like analytical method development, stability studies, Impurities characterization by coordinating with external labs, method transfers, Calibrations and Installations

- Reviewing & authorizing STPs, specification, JOS, COAs, SOPs, Guidelines,

Method development reports, Qualification documents, Justification reports,

Calibration reports, Change control, Incidence investigation

- Ensuring best quality/cost effective resources required for projects like columns/ chemicals/equipment/standards/impurities/filters before initiation of project

- Executing multiple projects & interfacing with customers for smooth execution of the projects

- Establishing cross functional coordination & collaboration with formulation develop

ment team, project team, validation team, Regulatory team, QC and coordination the analytical activities outsourced to vendors

- Setting performance parameters and ensuring team performance, building trust, encouraging commitment and accountability preparing JD, KRA, leave management, training, new skill development & appraisal

Research Scientist-IV (Team leader)

- Currently leading analytical method development and regular team containing 5 candidates with successful product delivery

- Having very good exposure in Analytical Method Development, Routine analysis, Stability Studies, Method validations, Method Transfers and communicating with other functional teams like QC, QA and RAD.

- Communicating with clients and CMO for smooth execution of the project.

- Handled different formulations like Solid dosage forms, Liquids, Soft gels and Injectable etc..,

- Adequate knowledge on Analytical Method Development, excipient compatibility studies and Force degradation studies to develop a Stability indicating methods for Assay and Related substances for finished dosage forms

- Preparation of Method development report, Standard Test Procedure, Specification and Analytical method transfer protocol for finished products

- Monitoring of Maintenance of LNB, Registers and other Documentation as per GLP

- Responsible to ensure proper recording of data, ensuring the records and raw data properly retained

- Co-ordination with Formulation Department, QC and RA/QA department for timely completion and smooth execution of projects.

- Ensuring properly and timely preparation of technical documents, reports and other documents

- Expertise in establishment and set up of new analytical lab, Installation, Operation and Performance Qualifications of new instruments.

- Impart training to the new recruits in the team on shop floor work

- Participated during USFDA audit in the plant.

Monitor the calibration of analytical instruments like HPLC, Dissolution, Balance etc.

- Responsible for Method Development of Related substances, Assay,

Uniformity of Dosage Units and Dissolution in different medias of Formulation

Drug Products

- Responsible for Method Development of compendial and non compendial methods

of related substances and assay for drug products and injections.

- Independently handling ANDA projects for analytical method development taking the decision related to projects.

- Support for identification and characterization of degradation products during stability of drug products using TLC, IR, and UV.

- Responsible for preparing STPs and Method development summary reports

- Training of the new joiners in Analytical Unit.

- Responsible for Preparing SOPs.

- Calibration of instruments as per the schedule.

- Responsible for Method Development of Related substances, Assay, Uniformity of Dosage Units and Dissolution in different medias of Formulation Drug Products

- Studying of impurity profile during force degradation for stability indicating method

- Responsible for preparing STPs and Method development summary reports

- Maintenance of working standards

- Maintenance of Records

- Monitoring Instrument Calibration due dates and performing the Instrument calibration

- Technology transfer of analytical methods at different plant location.

- Development and validation of new HPLC methods for drug products involving, Dissolution, Assay and Related substances.

- Stability Studies of drug products.

- Analysis of In-Process R&D Samples using by HPLC.

- Routine analysis of dissolution in different mediums, assay and related substances.

- Calibration of HPLC and UV as per schedule.