Sabika Rizvi
Slatington,PA
Summary
Dynamic and results-oriented manufacturing professional with over 10 years of expertise in aseptic operations, CAR-T manufacturing, and GMP-compliant environments. Proven track record of leading cross-functional teams and coordinating production in high-pressure settings while driving operational excellence. Known for adaptability, meticulous attention to detail, and a commitment to training and mentoring high-performing teams. Strong understanding of FDA regulations, batch documentation, deviation management, and cleanroom compliance, with a deep passion for enhancing patient lives through innovative cell therapy solutions.
Overview
10
10
years of professional experience
Work History
Sr. Specialist, Manufacturing Readiness
Legend Biotech
Raritan, NJ
03.2025 - Current
- Oversee operational readiness and execution of significant capital projects enhancing commercial manufacturing expansion, featuring cleanroom developments, technology transfers, and equipment integration.
- Drive end-to-end readiness for new manufacturing spaces, coordinating timelines, resources, and stakeholder alignment to ensure site capacity targets are met.
- Serve as the primary operations liaison with global and local MSAT, Engineering, Facilities, and Quality teams to ensure successful implementation of process and facility changes.
- Draft and evaluate technical documentation including user requirements, commissioning reports, and SOPs in accordance with regulatory standards.
- Ensure facility and process designs meet GMP and regulatory standards through structured walkthroughs, punch list reviews, and close-out documentation.
- Participated in project governance meetings to provide updates to senior leadership. Escalated risks and resourcing gaps impacting readiness timelines. Communicated project status effectively to ensure alignment with leadership expectations.
- Support training initiatives and knowledge transfer to manufacturing teams to ensure seamless operational ownership post-handoff.
Senior CAR-T Operations Supervisor
Legend Biotech
Raritan, NJ
03.2024 - 03.2025
- Lead day-to-day CAR-T production activities for multiple manufacturing units including Component Prep, Mock Cell, and Final Product processing under strict GMP regulations.
- Facilitate morning and evening shift meetings to align staff on goals, assignments, and critical updates.
- Act as the first point of contact for floor-related issues, ensuring swift resolution of deviations and ensuring compliance across all operations.
- Partner with Quality Assurance, Engineering, and Technical Teams to ensure seamless execution of production plans and equipment readiness.
- Contribute to major projects including Phase 3 readiness, smoke studies, LFG integration, and mock room testing initiatives.
- Lead the onboarding and development of new supervisors and operators; support mid-year and year-end reviews, goal-setting, and training compliance.
- Monitor daily throughput and escalate performance or schedule gaps to ensure patient batch execution meets deadlines.
- Oversee 10+ operators across two shifts, managing timecards, shift coverage, and adherence to operational KPIs.
- Serve as Expansion Team Supervisor, leading the operational readiness and startup of newly constructed cleanrooms to support Phase 3 manufacturing.
- Supported execution and coordination of EMPQ activities, including static and dynamic studies, as well as smoke studies to ensure environmental and airflow integrity.
- Participated in qualification activities for new equipment and rooms: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Partnered cross-functionally with QA, Facilities, Engineering, and Validation to align timelines and ensure successful commissioning of the new manufacturing space.
- Contributed to manufacturing investigations, authored/revised SOPs and batch records, and supported training and onboarding of new team members.
- Played a key role in readiness efforts for patient ramp-up, maintaining compliance while scaling operations efficiently.
CAR-T Operations Supervisor
Legend Bio-Tech
Raritan, NJ
06.2022 - 03.2024
- Directing the daily production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment.
- Job duties will be performed within a team-based environment, on an assigned production shift schedule.
- Lead and supervise multiple units within the CAR-T process operations (i.e component preparation manufacturing, MFG support operations, Mock cell, and CAR-T process) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
- Lead the daily start of shift operations meetings, the daily wrap up production meetings and assign individuals their daily production task to execute and ensure compliance and successful completion of work-related tasks.
- Work closely with operations personnel on the production floor to provide guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
- Support manufacturing investigations, create/revise operational procedures, including manufacturing work instructions, master batch records, forms, and support and manage change controls.
- Work closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
- Build strong partnerships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.
- Support the development of manufacturing processes, participate in various department projects, and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations
CAR-T Senior Manufacturing Associate Acting Team Leader
Bristol Meyers Squibb
Summit, NJ
01.2021 - 07.2022
- Making Sure the Team follows standard operating procedures.
- High level of understanding of cell therapy processes, controls, and GMP requirements.
- Subject Matter Expert
- Advanced proficiency ability to gown into applicable controlled areas per area classification specific requirements.
- Familiarity with cGMP/FDA regulated industry.
- Qualified Job Trainer.
- Working with Managers/Team Leads to create training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in timely manner
- Maintain up to date records for training on controlled, approved GMP procedures for Media and Buffer preparation to support CAR T manufacturing.
- Performed shift exchanges of information to ensure seamless operations.
- Work in cleanroom environment and perform aseptic processing, maintaining manufacturing environmental conditions.
- Strong partnerships with Manufacturing, Engineering, and Quality, and work as part of cross-functional team to complete production tasks required by shift schedule.
- Support development of manufacturing processes, and work with others to drive continuous improvements and efficiencies within cell therapy Operations.
- Performed routine environmental monitoring (EM: non-viable particulates, air viable, surface, and personnel) in cleanroom environments.
- Responsible for initiating, investigating, and writing deviation
- Carried out day-day-day duties accurately and efficiently
Manufacturing Technician III
AbbVie
Branchburg Township, NJ
04.2020 - 06.2021
- Trained in Cleanroom Operation, Aseptic Techniques, and working with bio-hazard materials.
- Manufacturing of tissue-based products for regenerative market. Follow standard operating procedures while manufacturing tissue-based products.
- Made sure that products were produced on time and are of good quality.
- Inspected products and machines to maintain quality and efficiency.
- Assess clean room environment, complete appropriate documentation, decide if immediate correction action can be implemented and notify appropriate required individuals
- Always maintain strict aseptic technique within ISO Class aseptic clean room processing environment to prevent contamination and cross contamination of environment and device.
- Use computer and SAP to enter data and generate reports. Maintain inventory of processing supplies. Responsible for sanitization of facility.
- Operating heat sealers, exsurco blades, biohazard laminar flow hoods, aspiration systems, and orbital shakers.
- Record information on batch records, equipment, and cleaning logs.
Certified Pharmacy Technician III
PharMEDium
Dayton, NJ
08.2016 - 04.2020
- Daily manufacturing for sterile bulk operations.
- Sterile Pharmaceutical Facility and Equipment
- Reconstitute bulk additives and prepare I.V. admixtures utilizing proper aseptic procedures under directions of Registered Pharmacist.
- Operate Automation Robots and Trouble shoot.
- Operate multiple styles of Pumps, Interact with Equipment through HMIs.
- Monitored employee training qualification schedule to remain complaint with internal standard Operating Procedures
Education
Mercer County Community College
Trenton, NJSkills
- ,Leadership, Mentoring & Shift Management
- Manufacturing Process Development
- Cross-Functional Collaboration
- Deviation Investigation & Change Control
- Experience with Microsoft Office, Microsoft Porjects, Oracle, SAP,S4 HANA eLIMS, MES, Trackwise, Comet, Veeva, Siemens, Bluebeam Revu
- Multitasking, Working in Teams
Timeline
Sr. Specialist, Manufacturing Readiness
Legend Biotech
03.2025 - Current
Senior CAR-T Operations Supervisor
Legend Biotech
03.2024 - 03.2025
CAR-T Operations Supervisor
Legend Bio-Tech
06.2022 - 03.2024
CAR-T Senior Manufacturing Associate Acting Team Leader
Bristol Meyers Squibb
01.2021 - 07.2022
Manufacturing Technician III
AbbVie
04.2020 - 06.2021
Certified Pharmacy Technician III
PharMEDium
08.2016 - 04.2020
Mercer County Community College