car t manufacturing associate resume example with 6+ years of experience
JessicaClaire
, , 609 Johnson Ave., 49204, Tulsa, OK100 Montgomery St. 10th Floor
H: (555) 432-1000
C:
resumesample@example.com
Date of Birth:
India:
:
single:
:
Professional Summary
Dedicated professional with history of meeting company Innovative and goal-oriented committed to professional development. Detail-oriented in production and expertise in handling fast-paced work. Proficient in the use of computers. Knowledgeable of working under strict SOPs and cGMP. Accomplishes production goals by working well with team members of different backgrounds and cultures. Skilled in working under pressure and adapting to new situations and challenges enhance the organizational brand.
Skills
Strong Leadership skills and ability to effectively communicate and influence Operations associate and convey information to Management.
Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell-based products, and cleanroom behaviors
Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
Strong analytical, problem solving and critical thinking skills and the ability to lead as a change agent to promote flexibility, creativity, and accountability.
An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment, while providing clear direction to team members.
Work History
CAR-T Operations Supervisor, 06/2022 - Current Te Connectivity – Troy, MI,
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.
Motivated and trained employees to maximize team productivity.
worked 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.
Worked closely with Operations Manager to help oversee the development of production personnel, provide input on personnel performance.
Built 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.
Monitored workflow to improve employee time management and increase productivity.
High level of understanding of cell therapy processes, controls, and GMP requirements.
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 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, 04/2020 - 06/2021 Chapters Health System – Wesley Chapel, FL,
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 of 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, 08/2016 - 04/2020 Walmart – City, STATE,
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
Pharmacy Technician, 03/2015 - 07/2020 Company Name – City, State,
Consulted with insurance company representatives to complete claims processing, resolve concerns and reconcile payments.
Communicated with patients to collect information about prescriptions and medical conditions or arrange consultations with pharmacists.
Processed incoming drug orders by checking deliveries against paperwork and updating computer system.
Entered and processed patients' prescriptions into internal system.
Communicated instructions to patients or caregivers about proper use and storage of drugs.
Communicated with prescribers to verify medication dosages, refill authorizations and patient information.
Performed wide range of pharmacy operations with strong commitment to accuracy, efficiency and service quality.
Maintained proper drug storage procedures, registries, and records for controlled drugs.
Helped pharmacist clear problematic prescriptions and address customer questions to keep pharmacy efficient.
Resolved non-routine issues like third-party billing, computer system and customer service issues.
Education
Associate of Science: Biology, Expected in 05/2025 - Mercer County Community College - Trenton, NJ GPA: Status -
High School Diploma: , Expected in 06/2013 - Hightstown High School - Hightstown, NJ GPA: Status -
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