Niraj Pradhan Email & Phone Number

Indianapolis, Indiana, Us

South Bend, Indiana, Us

South Bend, Indiana, Us

Warsaw, Indiana, Us

• Deliver the Quality Excellence QMS improvements in support of the corporate strategic plan • Perform raw data analysis, data verification, gap analysis and provided support on the current quality system metrics • Conduct monthly and quarterly quality system management review meeting and follow up on the action items• Monitor and manage CAPA, Non-conformance and Product Hold status through daily reporting and burndown charts• Support Process Monitoring and validation project related to various quality processes such as diffusion bonding• Support calibration of various Gages and support any issues due to Gage rejection• Support Quality harmonization project and internal/external audit• Provide SME support on various corporate and site level SOPs, KPI trending and work instruction related to quality system• Support any quality related activates related to IE, CAPA, HHE/HHED and Product Hold

Lawrence Township, Nj, Us

• Performed data analysis and process robustness analysis based on QbD methodologies for all drug product manufacturing sites • Implemented design control strategy to develop an end to end process performance• Supported global investigation of process deviation, data trending and change controls• Supported green belt project execution using Lean 6-Sigma methodologies• Performed batch analysis of commercial, engineering and clinical batches to develop Cpk models providing key process parameters and CPPs for process monitoring• Performed manual and automatic process performance data extraction, reporting and analysis• Coordinated the execution of laboratory based studies in support of commercial manufacturing facilities, including design of experiment, scheduling, communication, coordination of sample delivery and data collection• Provided tech transfer support for external manufacturers (CMOs) of biologics drug products • Coordinated lab scale evaluation of the manufacturing process for expansion and optimization of the commercial manufacturing process including tangential flow filtration (TFF) and single use technology (SUT) studies• Provided technical support, impact assessment and characterization for the new technology implementation• Investigate, troubleshoot and resolve the manufacturing related critical issues, product release performance and/or complaints• Review, analyze and present in-process, visual inspection, release and stability data trends to upper management

Binghamton, Ny, Us

• Investigated the differentiation of hPSC into beta cells for the treatment of Type II diabetes • Researched on biodiesel production (upstream and downstream process) using microalgae• Designed paper-based microfluidics device for the separation of the blood-plasma proteins• Investigated drug target prediction using the complex data network theory

Somerset, Nj, Us

• Performed GMP Master Batch Record (MBR) development, review and approval process for clinical and pre-commercial development drug products • Provided direction, input, review and approval of Engineering studies, validation protocols and reports for facilities, equipment, systems and utilities to ensure thoroughness, accuracy and compliance with company policies and procedures• Wrote SOP for manufacturing equipment like Blenders, Roller Compactors, Fitzmills, Oscillating Granulator, Encapsulators and revised existing procedures as needed• Supported in design and implementation of new manufacturing processes or changes to existing processes and oversee new equipment implementation and validation• Reviewed formulation process protocol including DOE and formulation development report for solid dosage form manufacture.• Wrote deviations/non-conformances and investigation reports for any manufacturing process issues• Worked with quality assurance team to ensure appropriate root cause determination, quality impact assessment and CAPA development/implementation• Conducted statistical analysis of manufacturing data using statistical tools such as SPSS, Minitab and STATA• Work closely with other teams for scale-up and pre-commercial development processes• Supported in troubleshooting and resolution of drug manufacturing process and equipment issues

Paris, France, Fr

• Performed validation of analytical instruments like HPLC, GC, LCMS, UPLC, Atomic Absorption Spectrometer, UV/Vis Spectrophotometer, Karl Fisher Titrator, cIEF, Laser Densitometer, Face Imager, Particle counter, TOC Analyzer, Oxygen Analyzer, Analytical Balance, Mass Flow Meters and Controllers, Plate Reader• Authored User Requirement Specification (URS), Configuration Specification (CS), IOQ and PQ for the Analytical Instruments• Executed SAT, IQ, OQ and PQ, analyzed validation protocol execution data and prepared validation summary report• Involved in performing GAP Analysis to investigate gaps between system operation and the requirements of FDA regulations over the current system and prepared Remediation Plan to fix the gaps identified• Initiated and approved CAPA and change control for any deviation encountered during the validation process• Performed a peer review meeting process with the Quality Control and Quality Assurance management team to review and approve the validation documents• Used data management tools like LIMS and Trackwise to manage the analytical laboratory data• Participated in cGxP and 21 CFR Part11 compliance assessment for all the laboratory equipment and its related software• Reviewed business requirements and participated in designing Validation Master Plan• Developed and revised Standard Operating Procedures (SOP’s) for preparing IQs, OQs and PQs• Involved in reporting, tracking, follow-up and closure of all non-conformances and deviations• Prepared Trace Matrix to track all the user requirements and configuration requirements with the IOQ protocol

New Brunswick, Nj, Us

• Responsible for writing and executing Validation Protocols (SAT, IOQ & PQ) and Commissioning Test Protocols for utility systems(Clean Steam Generator, Pure Water Generation and Distribution, Compressed Air Unit, Plant Steam Boiler), process equipment(Autoclave, Isolator, Component Washer, UV-Visible Spectrophotometer, Centrifuge, Fermenter, Incubator, Refrigerator, Freezers, Fraction Collector), facility and HVAC• Worked in compliance with FDA regulations and cGxP guidelines in all the aspects of Validation process• Conducted Vendor documentation verification, design specifications and updated Engineering Drawing and P&IDs of all the utilities and equipment based on change requirements• Validated Allen Bradley PLC/HMI system based process equipment and testing of SCADA system• Developed and reviewed Standard Operating Procedures (SOP’s) for Preventative Maintenance of utilities and process instruments• Performed temperature-mapping validation on different types of instruments using KAYE Validator 2000• Performed Gap Analysis and prepared Remediation Plans to fix the gaps identified• Prepared final summary report and turn over packages for utility systems• Conducted ERES assessment of analytical instrument related software according to 21 CFR part 11 requirements• Wrote a protocol exception for any types of deviation encountered during the validation process and wrote a corrective action plan to remedy it• Verified process and equipment drawings accurately reflect the current as-built status of the system• Conducted calibration for all critical instruments of process equipment and utilities

• Support Generation of User Requirement Specifications and execute engineering documents pertinent to commissioning• Perform field/site activities pertinent to FATs and SATs, vendor start-up testing, and execution of commissioning, qualification and validation protocols.•Author validation documentation including, but not limited to, Installation, Operational and Performance Qualification protocols and reports, Process Validation protocols and reports, Cleaning Validation protocols and reports, and Protocol Discrepancies and Addenda.•Prepare Cleaning and Process validation protocols according to internal and external requirements.•Execute qualification, cleaning and process validation tests in accordance with approved protocols, procedures and guidelines.•Analyze cleaning and process validation test data to determine systems have met validation criteria.•Write process and cleaning validation final reports that offer conclusions based on test results.•Document testing results in validation/qualification protocols per protocol requirements; obtain samples to be analyzed per qualification/validation protocol requirements.•Assure that all validation activities are performed in compliance with approved validation/qualification protocols, standard operating procedures (SOPs), and current regulatory requirements/guidelines.•At the discretion of VP or Director of Engineering, approve validation protocols in areas where the specialist is deemed a subject matter expert•Keep current on regulatory and quality requirements for manufacturing, qualification, and validation activities.

Edmond, Ok, Us

• Designed and assembled micro tension and bend test setup for in-situ and ex-situ Field Emission Scanning Electron Microscope (FESEM) conditions• Designed experiment to conduct fracture strength of bone-composite cement • Examined the effect of Hydroxypatite and Chitosan nanoparticles on the fractural strength of PMMA bone cement• Investigated the influence of biomaterials on the interfacial fractural strength of PMMA bone cement • Designed Whiplash mechanism using automated tensile testing machine• Designed temperature controlled bath for the analysis of engineered tissue grafts

Drug And Medical Device Development

Project Management

Master Of Science (M.S.), Bioengineering And Biomedical Engineering

Bachelor Of Science (B.S.), Biomedical/Medical Engineering Minor: Mathematics