Highly productive and efficient Senior Scientist and Validation Engineer with expertise in biotechnological techniques, data analysis, and experimental design. Recognized for exceptional critical thinking, problem-solving, and collaboration skills. Achieved success in process development initiatives and team projects.
Overview
12
12
years of professional experience
Work History
LEAD SENIOR PROCESS VALIDATION ENGINEER-PROCESS VALIDATION
PFIZER - OXFORD GLOBAL RESOURCES INC
Rocky Mount, NC
04.2023 - Current
Lead team of 30+ Engineers in major process validation project (validation of new automated manufacturing facility, five new filling lines and new process validations processes for all products made at the site)
Subject matter expert for Process Validation activities (commercial aseptic and terminally sterilized Solid Volume Parenteral drug products)
Provide technical support to manufacturing and quality department for drug product questions (investigations, technical)
Generate, review and execute PV Protocols, Batch records, data sheets and other GMP documents related to the Validation and Release of commercial drug product batches for sale in multiple markets
Oversee process validation operations, sampling, scheduling, and ordering and delegate responsibilities
Implement, initiate and oversee Change Controls and CAPA's and deviations
Work in close collaboration with regulatory, project management, manufacturing, quality control and quality assurance
PROCESS DEVELOPMENT SCIENTIST III- MSAT PROCESS VALIDATION
LONZA HOUSTON INC - OXFORD GLOBAL RESOURCES INC
12.2021 - 12.2022
Subject matter expert for CMO Fill Finish and Aseptic Qualifications Programs for Cell & Gene Therapy and Viral Vector Drug Products
MSAT Process Validation lead for multiple projects, established process parameters and specifications required for the Drug Product fill finish vialing and sealing process
Managed projects BOM/SAP, SOW changes, timelines and schedules
Authored technical assessments regarding specification changes for raw materials and implemented process CAPA's and Change Controls (Trackwise)
Evaluated Vendor notification changes and proactively addressed risks and process issues
Provide process oversight, analyzed, reviewed and presented key findings and process outputs to internal teams, external clients and company leadership
Performed technical writing, document creation & review of cGMP Batch Records, deviations, SOP's, Validation Protocols (protocol and report generation, troubleshooting equipment issues)
Participated in regulatory filling readiness and Audit responses from external clients and FDA
Assist with CAPEX regarding the Facility and Filler/Sealer equipment enhancements
SENIOR SCIENTIST- UPSTREAM PROCESS DEVELOPMENT
AGC BIOLOGICS INC OXFORD GLOBAL RESOURCES
11.2019 - 11.2021
Upstream Lead for CMO working with clients to design and optimize CHO cell culture processes and bioreactor operations
Manage processing timelines, interpret data, provide client updates
Execute characterization and DOE studies for CHO mammalian cell lines from culture through bioreactor harvest (Stir Tank 2000L, Profusion, Amber 250)
Optimization of growth media, and production parameters for stable cell lines
Design experiments, developed scale up strategies, and collaborate with internal teams to improve cell growth and titer (use metabolic data to improve batch and feed media strategies)
Analyzed and interpreted Process Development and Manufacturing data in order to implement process changes, trended analytical data (JMP, Excel)
Performed technical writing and review of Protocols and Summary Reports
Reviewed and approved GMP manufacturing and compliance (Batch Records, Technical assessments & Validation Protocols)
SME and Trainer on Amber 250 High throughput automated 24 vessel Bioreactor System
SCIENTIFIC & TECHNICAL OPERATIONS SCIENTIST I- PROCESS DEVELOPMENT
ADMA BIOLOGICS
10.2018 - 11.2019
Subject Matter Expert for Plasma Fractionation/Purification commercial manufacturing process for plasma derived products
Execute upstream and purification studies (formulation, filtration, UF/DF, Chromatography) and perform analytical lab testing (spectroscopy, pH)
Author and review regulatory and CMC documentation for GMP products BLA/IND filling and technical literature
Lead deviation investigations and implemented CAPA's and corrective actions for manufacturing processes
Author process Risk Assessments and Criticality Reports based on process CMC and report
Perform review of Extractables and Leachable quality testing and generate internal reports
Evaluated and analyzed process data, parameters, results and executed documents
Author and execute Process Development Cell culture & Media Optimization, DOE and Characterization studies (CHO, Hybridoma, Melanoma cells)
Perform small scale Bioreactor upstream operations (up to 200L, Stir tank and Profusion harvest of monoclonal antibodies and recombinant protein)
Perform downstream processing operations (Protein A purification, Titer analysis)
Investigated process deviations and generated CAPA's and change controls for process improvements
Project Management and CMO Subject matter expert for Process Development Cell Culture projects, worked closely with external clients and cross functional teams to drive timelines
Track and trend data in laboratory notebook and databases
Support the technical transfer of manufacturing process from development to scale up and commercial manufacturing
Technical writing of GMP SOP's, batch records, summary reports, deviations for executed studies/batches
Supervised commercial large scale media prep team and Aseptic filling qualification training
Education
MASTER OF BUSINESS ADMINISTRATION - International Business
<ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group<ul><li>Production Block Incharge Job Role: Operations, Control and Monitoring</li><li>1. All activities related to production and monitoring the process as per SOPs.</li><li>2. Communicate day to day process deviations and breakdowns of the equipment to concerned persons.</li><li>3. Check and implement the process for cleaning of equipment as per the schedules.</li><li>4. Responsible for housekeeping and implementation of day to day cleaning of process area & clean room.</li><li>5. Preparation, review and approval of monthly Reports and BPRs BCRs, OOS, Deviation, investigations reports, validation protocols reports, validation reports.</li><li>6. Responsible for preparation of daily production planning and ensuring the same.</li><li>7. Production planning, ensuring that the batches are produced as per planning and meeting the dispatch targets.</li><li>8. Ensure proper utilization of equipment and manpower as and when required.</li><li>9. Planning and monitoring during execution of the process validation.</li><li>10. Manpower planning. Monitor the project modification activities.</li><li>11. Responsible to handle production processes.</li><li>12. Implementation of new technology w.r.t. process equipments or facility.</li><li>13. Supporting quality assurance team for DMF submission.</li><li>14. Executing and supervising training, validation, qualification and calibrations protocols.</li><li>15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.</li><li>CGMP:</li><li>1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.</li><li>2. Making sure all the documents and checklist are verified before and after manufacturing.</li><li>3. Ensuring retention and destruction of records are maintained in a department.</li><li>4. Verifying status labeling of accessories, in-process instruments, containers, area & equipment.</li><li>5. Performing contemporaneous (on time) document entries.</li><li>EHS:</li><li>1. Following Environment, Health and Safety policies and practices.</li><li>2. Making sure personnel health, hygiene and organization practices are followed.</li><li>3. To conduct risk analysis of product, system, equipment, process as per standard procedure.</li><li>Training</li><li>1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).</li></ul> at MSN Group
Led cross-functional teams to manage daily spare order processing, ensuring seamless coordination between service, stores, and finance teams. Maintained high order accuracy and reduced communication gaps across departments.Trained over 100+ service engineers on CRM workflows, POD updates, and return processes during HO commercial trainings. Improved field team compliance and reduced repeat errors by over 20%.Owned end-to-end order lifecycle, including documentation, dispatches, POD tracking, and MIS reporting with minimal supervision. Enabled faster turnaround and higher accuracy in daily operations.Acted as a central escalation point between field engineers, HO departments, and senior managers to resolve system and order-related issues. Reduced escalations by ensuring proactive resolution within SLA timelines.Managed return spare process and validations, driving a 25% reduction in turnaround time and improving system accuracy. Ensured proper coordination with service and stores for smooth transaction closures.Initiated Kaizen process improvements for workflow automation, documentation, and order validation. Reduced manual work by 30% and helped in faster issue identification.Collaborated with IT team to test and implement new CRM workflows and resolve service module-related bugs. Ensured seamless migration and better user experience for the service team.Created and presented MIS reports for weekly DRM meetings and management reviews. Supported data-driven decisions and provided insights on pending and completed orders.Monitored pending orders and stock validations daily across CFA locations. Achieved 15% reduction in follow-up delays by implementing checklist-based follow-ups.Handled distributor and spot-visit orders, ensuring compliance with internal policies and faster processing. Reduced lead time by 20% with improved documentation and follow-ups.Supervised stock accuracy across locations and led reconciliation activities with store teams. Brought down discrepancies by 15% through structured checking and documentation.Prepared CRM master data and validated engineer records for smooth CRM transition. Increased CRM accuracy by 25% before new system rollout.Managed price lists and quotations, communicating with teams to ensure correct rates and GST compliance. Prevented billing errors and improved customer satisfaction on pricing clarity.Maintained GEM and E-Invoice portal compliance, uploading documents accurately to meet government requirements. Ensured zero rejection in audits and smoother order execution for public sector clients.Followed up on loan spare recoveries, ensuring 95% payment recovery by accurate tracking and coordination with accounts. Reduced pending dues and ensured clean financial closure of orders. at Transasia Bio-Medicals LtdLed cross-functional teams to manage daily spare order processing, ensuring seamless coordination between service, stores, and finance teams. Maintained high order accuracy and reduced communication gaps across departments.Trained over 100+ service engineers on CRM workflows, POD updates, and return processes during HO commercial trainings. Improved field team compliance and reduced repeat errors by over 20%.Owned end-to-end order lifecycle, including documentation, dispatches, POD tracking, and MIS reporting with minimal supervision. Enabled faster turnaround and higher accuracy in daily operations.Acted as a central escalation point between field engineers, HO departments, and senior managers to resolve system and order-related issues. Reduced escalations by ensuring proactive resolution within SLA timelines.Managed return spare process and validations, driving a 25% reduction in turnaround time and improving system accuracy. Ensured proper coordination with service and stores for smooth transaction closures.Initiated Kaizen process improvements for workflow automation, documentation, and order validation. Reduced manual work by 30% and helped in faster issue identification.Collaborated with IT team to test and implement new CRM workflows and resolve service module-related bugs. Ensured seamless migration and better user experience for the service team.Created and presented MIS reports for weekly DRM meetings and management reviews. Supported data-driven decisions and provided insights on pending and completed orders.Monitored pending orders and stock validations daily across CFA locations. Achieved 15% reduction in follow-up delays by implementing checklist-based follow-ups.Handled distributor and spot-visit orders, ensuring compliance with internal policies and faster processing. Reduced lead time by 20% with improved documentation and follow-ups.Supervised stock accuracy across locations and led reconciliation activities with store teams. Brought down discrepancies by 15% through structured checking and documentation.Prepared CRM master data and validated engineer records for smooth CRM transition. Increased CRM accuracy by 25% before new system rollout.Managed price lists and quotations, communicating with teams to ensure correct rates and GST compliance. Prevented billing errors and improved customer satisfaction on pricing clarity.Maintained GEM and E-Invoice portal compliance, uploading documents accurately to meet government requirements. Ensured zero rejection in audits and smoother order execution for public sector clients.Followed up on loan spare recoveries, ensuring 95% payment recovery by accurate tracking and coordination with accounts. Reduced pending dues and ensured clean financial closure of orders. at Transasia Bio-Medicals Ltd
<ul>
<li>Responsibilities -Process Engineering: -</li>
<li>Responsible for making SOP on required process flow for overall manufacturing.</li>
<li>Responsible for doing validation and closing buy off points in line before starting an NPI.</li>
<li>Making process mapping for on scrap and process issues to increase productivity in manufacturing.</li>
<li>Responsible for doing analysis and making actions against failure to reduce production loss.</li>
<li>Achieving standard targets requirement from customer end related to yield and scrap.</li>
<li>Responsible for confirming QOC and OBA failures and as well as making analysis on that and sharing RCA (Root Cause and Analysis) to CFT (Cross Functional Team).</li>
<li>Conducting MOM (Minutes of Meeting) on daily basis Among the Yield, Scrap and Production.</li>
<li>Responsible for preparing PFMEA on process stages inline.</li>
<li>Making a SWR (Special Work Request) for any process change to improve yield and productivity.</li>
<li>Responsible for making reports based on analysis with PPT, and conducting CFT to present reports for failure reduction.</li>
<li>Maintaining good yield graphs toward the given targets.</li>
<li>Time study, standard time and manpower request, capacity analysis, and line balancing analysis.</li>
<li>Preparing DFMA reports of manufacturing and assembly based on criticality. Process improvement activities and continuous improvement of the manufacturing process, material handling, and line layout.</li>
<li>Organizing and executing all process activities, such as rejection and scrap reduction.</li>
</ul> at Sunny Opotech India Pvt.Ltd<ul>
<li>Responsibilities -Process Engineering: -</li>
<li>Responsible for making SOP on required process flow for overall manufacturing.</li>
<li>Responsible for doing validation and closing buy off points in line before starting an NPI.</li>
<li>Making process mapping for on scrap and process issues to increase productivity in manufacturing.</li>
<li>Responsible for doing analysis and making actions against failure to reduce production loss.</li>
<li>Achieving standard targets requirement from customer end related to yield and scrap.</li>
<li>Responsible for confirming QOC and OBA failures and as well as making analysis on that and sharing RCA (Root Cause and Analysis) to CFT (Cross Functional Team).</li>
<li>Conducting MOM (Minutes of Meeting) on daily basis Among the Yield, Scrap and Production.</li>
<li>Responsible for preparing PFMEA on process stages inline.</li>
<li>Making a SWR (Special Work Request) for any process change to improve yield and productivity.</li>
<li>Responsible for making reports based on analysis with PPT, and conducting CFT to present reports for failure reduction.</li>
<li>Maintaining good yield graphs toward the given targets.</li>
<li>Time study, standard time and manpower request, capacity analysis, and line balancing analysis.</li>
<li>Preparing DFMA reports of manufacturing and assembly based on criticality. Process improvement activities and continuous improvement of the manufacturing process, material handling, and line layout.</li>
<li>Organizing and executing all process activities, such as rejection and scrap reduction.</li>
</ul> at Sunny Opotech India Pvt.Ltd