Aashika Shahpatel
Phillisburg,NJ
Summary
Operational professional with experience in CAR-T manufacturing, laboratory testing, specimen processing, and medical billing. Supports cGMP workflows through accurate documentation, aseptic processing, cryopreservation, and safe material handling while helping maintain production schedules, audit readiness, and quality standards.
Overview
17
17
years of professional experience
Work History
Operator, Cryopreservation for CAR-T
Janssen Pharmaceuticals, Inc.
Raritan, NJ
08.2022 - Current
- Be part of the manufacturing operations team responsible for the production of autologous CAR-T products for clinical and commercial operations in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
- Execute manufacturing activities common to cell culturing, purification, aseptic processing, and cryopreservation using appropriate techniques.
- Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
- Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).
- Work in a team-based, cross-functional environment to complete production tasks required by the shift schedule.
- Drove continuous improvement of manufacturing operations through observations and input from team members.
- Aided in development of manufacturing processes and corresponding documentation.
- Handle human-derived materials in containment areas.
- Support schedule adjustments to meet production.
- Accurately complete documentation in SOPs, logbooks, and other GMP documents.
- Maintained a working knowledge of basic cGMP requirements to adhere to compliance policies and regulations.
- Wear the appropriate PPE when working in manufacturing and other hazardous working environments.
- Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors
- Ensure materials are available for production.
- Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
- ADDITIONAL RESPONSIBILITIES/DUTIES:
- Support the ongoing production schedule by.
- Executed tasks to support team objectives.
- Practice good interpersonal and communication skills.
- Demonstrate a positive team-oriented approach in the daily execution of procedures.
- Promote and work within a team environment
- Learn new skills, procedures, and processes as assigned by management and continue developing professionally.
- Support investigation efforts as required.
- Responsible for audit preparation and participation.
LAB TECHINIAN
Lab Corp. Laboratory Corp of America
Raritan, New Jersey
06.2013 - 07.2022
- Forensic Toxicology Dept. at Raritan , New Jersey.
- Accession of urine for drug screening.
- Coordinated aliquot distribution for confirmed positive GC/MC tests, ensuring accurate tracking and compliance.
- Performing laboratory tests including pre-and post-analytic Phases. Producing accurate and reliable data and interpreting results.
- Adhered to established procedures, policies, and health/safety guidelines to ensure laboratory compliance and safety.
- Followed the Lab procedures for storage of excess specimen samples & documentation.
- Worked on HP3000 & UNISYS 1100 systems for information analysis.
- Maintaining record,answering phones and emails. Maintained GMP compliance with standard operating procedures. Validation and qualification of process equipment and systems. Internal quality/GMP compliance adults.
AMNEAL PHARMICALS
06.2013 - 01.2016
- Tasks Performed
- Maintain 100% cGMP & compliance during packaging operation.
- Checking and verifying bulk and packaging components before entering the packaging room.
- Record and maintain the logbook after each batch.
- Check and verify Product/ Outserts/Label as per product specification in the batch record, work order and packaging records.
- Responsible for the packaging Line/room is clean, organized and ready for Packaging operations.
- Check calibration status of all scales, balance and equipment.
- Responsible for disposal of rejected tablets and packaging components in the designated area.
- Use proper safety and protective Gears and follow Dress Code.
Warehouse Associate
Kuehne & Nagel
03.2012 - 05.2013
- Worked within the AS400 database for product availability, shipping and tracking information for all e-commerce and store replenishment for 180+ stores for Louis Vuitton nationwide.
- Utilized RF scanner for accurate inventory tracking, shipment processing, and receiving reports.
- Created labels and managed internal employee orders, ensuring customer satisfaction through effective packaging and product availability.
Assembly and Quality Inspection
Swan Cosmetics
01.2012 - 04.2013
- Assembled cosmetic products and inspected quality, ensuring compliance with company standards.
- Completed day-to-day duties accurately and efficiently.
- Contributed innovative ideas and solutions to enhance team performance and outcomes.
- Worked successfully with a diverse group of coworkers to accomplish goals and address issues related to our products and services.
Medical Biller & EKG Technician
MD Manesh Soni & Mehesh Patel
08.2009 - 01.2010
- Conducted electrocardiogram (EKG) and stress testing to record patients' cardiac activity.
- Set-up and calibrated specialized cardiac diagnostic equipment
- Performed EKG and IV's, drew blood, vital signs, finger sticks, injections and medical procedures.
- Obtained and recorded patient identification, medical history or test results and explained testing procedures.
- Refrigerated specimens for later lab testing and distributed the tubes to specified locations.
- Managed inventory of medical supplies, ensuring availability by reordering and stocking carts and hand trays.
- Resolved payment issues by actively coordinating with insurance providers to ensure accurate account management.
- Resolved account balances and assisted in the follow up and collections process.
- Preparation of payment batches and posting payment within the system.
- Generated balance letters for patients and coordinated with insurance companies for timely follow-up.
- Obtained missing information and prepared patient invoices and insurance claims forms.
- Understood CMS-1500 forms, workers' compensation, follow-up procedures, balance letters, and rejection letters.
- Expert in Medisoft and Medical Manager Billing software. Checked claim status with insurance companies and generated collection letters to patients.
- Ensured proper payment amounts were received from patients and insurance.
Education
Degree -
Middlesex Community College
01-2011
High School Diploma -
Piscataway High School
01-2009
Skills
- Data Managementtenancecesses
- Operating systems
- Regulatory Standards
- Software suite Manufacturing
- Operating systems
- Operating systems
- Excel
- Word
- PowerPoint
- Word
- Operating systems
- Operating systems
- Operating systems
- Operating systems
- Word processing software
- cGMP compliance
- Process validation
- Safety awareness
- Mechanical understanding
- Hand and power tools
- Manufacturing procedures
- Quality control processing
- Quality assurance
- Data entry
- Teamwork and collaboration
- Warehouse operations
- Problem solving
- Specimen handling
- Batch record review
- Good documentation
- Cleanroom operations
- Cryopreservation techniques
- Cell culture
- Aseptic processing
Timeline
Operator, Cryopreservation for CAR-T
Janssen Pharmaceuticals, Inc.
08.2022 - Current
LAB TECHINIAN
Lab Corp. Laboratory Corp of America
06.2013 - 07.2022
AMNEAL PHARMICALS
06.2013 - 01.2016
Warehouse Associate
Kuehne & Nagel
03.2012 - 05.2013
Assembly and Quality Inspection
Swan Cosmetics
01.2012 - 04.2013
Medical Biller & EKG Technician
MD Manesh Soni & Mehesh Patel
08.2009 - 01.2010
Degree -
Middlesex Community College
High School Diploma -
Piscataway High School