Kazim Rizvi Email & Phone Number

United States

Burlington, Ma, Us

In a recent campaign, my MFG team and I successfully managed and executed an overseas client's drug manufacturing process with meticulous attention to detail, impressing the client and securing additional contracts worth up to $10 million in revenue. I am excited to lead this project, starting in July 2024.

Burlington, Ma, Us

- Managed projects and campaigns efficiently, achieving exceptional results with zero rework.- Developed viral vector materials for rheumatoid arthritis and multiple sclerosis, specializing in cell expansion.- Led initiatives for cancer treatment and vaccine development.- Guided an 11-member technician team, optimizing training modules and conducting on-the-job training.- Directed cGMP-compliant production, enhancing quality, safety, and manufacturing schedules.- Led CAPAs, GDP, and deviation initiatives, ensuring accurate production documentation.- Improved employee efficiency through time management and project scheduling.- Supervised upstream and downstream processes, ensuring smooth operations.- Collaborated with clients and Tech Transfer for seamless engineering to GMP transitions.- Key role in FDA inspections, addressing inquiries and ensuring compliance.

Burlington, Ma, Us

- Executed manufacturing processes for diverse client projects, ensuring strict compliance with cGMP standards and maintaining high-quality standards.- Collaborated with Tech Transfer to develop custom Master Batch Records, fostering effective communication with clients and demonstrating leadership in cGMP manufacturing operations.- Actively participated in aseptic product fills, including 0.2 ml and 10 ml fills in Bio Safety Cabinets.- Managed product labeling activities successfully.- Trained personnel on fill-finish tasks to ensure proficiency and adherence to requirements.- Oversaw project scheduling and timelines.- Coordinated resources, including personnel and equipment, efficiently.- Initiated and completed Corrective and Preventive Actions (CAPAs), General Corrective Communications (GCCs), events, and deviations to drive continuous improvement.- Conducted training as a qualified trainer, ensuring personnel mastery of visual inspection criteria.- Led a team of 5 technicians with zero errors during fills, showcasing effective leadership skills.- Directed process improvement projects to optimize efficiency and effectiveness.

San Diego, California, Us

- Led a team of 7 technicians, managing schedules and ensuring approval of manufacturing data and batch records.- Efficiently managed capacity (equipment and labor) to meet quarterly demands.- Executed critical processes: Change Controls, Deviations, CAPAs, and NCMRs.- Collaborated with development teams, leading improvement projects.- Developed tools and reports for process monitoring and actionable insights.- Played a key role in recruiting and retaining talent, contributing to strategic goals and KPIs.- Maintained safety and cleanliness standards, adhering to cGMP, 5S, and procedures.- Assisted in QMS implementation and worked in cleanroom and BioSafety Cabinet environments.Projects and Accomplishments:1. SOP Overhaul for GMP Manufacturing: - Led a comprehensive SOP overhaul, addressing FDA findings including documentation control, data integrity, cleanroom and utility shutdowns, and event response. - Authored SOPs and logbook templates for major and minor equipment. - Conducted training sessions for manufacturing personnel on logbook usage. - Facilitated meetings with Document Control, Quality Assurance, and other departments for alignment.2. Transition of Sterile Clean Cap Fills: - Spearheaded the transition of Sterile Clean Cap Fills from Pilot to GMP Manufacturing. - Ensured aseptic technique alignment with standards. - Reduced filling cycle time from 6 to 3 hours, enhancing efficiency. - Streamlined QC sample submission for PETSMART from 2 hours to 15 minutes. - Collaborated with departments for time-saving procedures, enhancing future process efficiency.

Tampa, Florida, Us

• Led a team of four manufacturing technicians in an aseptic clinical pharmaceutical product development environment, ensuring timely production within cost, quality, safety, and productivity parameters.• Spearheaded a successful turnaround in team performance using PDCA methodology for sustainable improvement in processes.• Supervised daily aseptic manufacturing operations, including filter integrity tests, CIP, COP, and SIP, adhering to a 12x7 schedule.• Revised, reviewed, and approved standard work instructions, batch filling records, and SOPs.• Mentored junior technicians, facilitating compliance and technical training.• Utilized Master Control QMS for quality event reports and ESI for resource planning and inventory tracking.• Identified workflow inefficiencies, proposed reorganization plan, and motivated team for its execution.

Tampa, Florida, Us

• Designed and executed laboratory and pilot plant experiments, identifying critical process attributes and assessing manufacturing capabilities.• Managed cross-functional relationships with production, engineering, validation, and quality departments.• Prepared and maintained records for smooth process technology transfer.• Conducted in-process lab analyses, including HPLC and particle size distribution.• Provided on-the-floor technical support, trained technicians on pre-clinical product batch execution.• Planned, executed, and documented development/clinical/validation/commercial manufacturing activities.• Utilized QbD and DOE methodologies for investigation studies and process improvements.• Analyzed and presented data using Excel and PowerPoint tools.• Participated in new employee hiring processes.

Tampa, Florida, Us

• Managed various manufacturing tasks involving pressurized vessels, CIP, SIP, and bulk systems.• Ensured compliance with FDA standards, maintained production batch quality documentation.• Conducted investigations, identified root causes, and implemented corrective actions.• Trained manufacturing operators, reducing production time by 30%.• Qualified trainer for all aspects of Bulk MFG process.• Assisted Facilities, Calibration, and Engineering during production shutdowns.• Conducted specialty study batches for in-vitro release and process improvement.

Tampa, Florida, Us

• Trained and supervised production activities, cross-trained in fill and doc control departments.• Compiled manufacturing troubleshooting guide covering various issues.• Participated in pipeline product development and production.• Communicated floor observations and performed basic troubleshooting.• Qualified in departmental aseptic process simulation.• Conducted training on gasket and clamp use.• Assisted other departments with 5S organization.• Created building management system guide for new trainees.

Tampa, Florida, Us

• Executed tasks such as integrity testing, glassware washing, and autoclave operations.• Managed material orders, weighing, and chemical dispensing with minimal wastage.• Completed GMP documentation and clean room gowning training.• Supported medium qualification requirements.• Adhered to EH&S policies and procedures.• Improved filter testing assembly, reducing cycle time from 45 to 15 minutes.

Tampa, Florida, Us

• Managed Batch/Continuous production & Plant operations at a Polyester Fiber Plant using DuPont Technology.• Explored production of various polymer variants, including low-pill polymer and semi-dull optical bright polymer.• Implemented Monitoring & Reporting practices of KPIs to improve production rate, quality consistency, and customer satisfaction.• Coordinated with Purchasing for timely procurement of raw materials based on specifications.• Collaborated with sales and marketing team for production planning and scheduling.• Participated in a plant optimization study for improved efficiency.• Developed skills in Safety Management & Systems Awareness, Policy & Procedures.• Led the Water Quality Improvements Project (Rs.75M), including reverse osmosis system and effluent treatment plant.• Conducted Plant Capacity studies and successfully implemented findings to increase up-rate.• Managed preventative maintenance and calibration of plant equipment, including gas turbines, boilers, cooling towers, and more.• Supervised materials procurement for various operations teams.• Led a team of 10+ production employees, consistently meeting production goals in a fast-paced environment.

Karachi, Sindh, Pk

Karachi, Sindh, Pk

Karachi, Sindh, Pk

• Investigated the workings of a Urea Fertilizer Plant and performed extensive R&D which involved experimental development and applied research on the Ammonia and Urea Production section.

Karachi, Pk