Kendy Hernández
Lawrence,MA
Summary
Efficient Manufacturing Associate with 8+ years of experience, recognized for high productivity and ability to complete tasks swiftly. Possess specialized skills in quality control, machinery operation, and safety protocols that ensure consistent excellence in production environments. Excel in team collaboration, problem-solving, and adaptability, bringing valuable soft skills to optimize manufacturing processes and outcomes.
Overview
8
8
years of professional experience
Work History
Manufacturing Associate II, Cell Therapy
Bristol Myers Squibb
03.2022 - Current
- Perform patient process unit operations and support operations described in standard operating procedures and batch records
- Complete documentation required by process transfers protocol, validation protocol, standard operation procedures, and batch record
- Complete training assignments to ensure the necessary technical skills and knowledge
- Execute daily unit operations schedule that include people, product, and material flow across multiple shifts
- Trained on Aseptic technique: tube welding, connections, and transfer
- Proficient in human cell therapy processes such as activation, transduction, cell culture, harvest.
- (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global health Autority requirements
- Knowledge with cell processing equipment such as Sepax c-pro and Xuri cell expansion system
- Records production data and information in a clear, concise format according to proper GDocPs
- Work in a team based, cross-functional environment to complete production tasks required by shift schedule
- Operate production equipment within an assigned functional area adhering Good Manufacturing Practices (GMPs) and standard operating procedures (SOPs)
- Works in a team based, cross-functional environment to troubleshoot any process related issues.
Senior formulation technician
Thermo fisher science
11.2021 - 10.2022
- Clinical and Commercial Manufacturing, Upstream, Midstream and Downstream
- 293HEK Cells: Daily Maintenance, Passages, transfection, and Harvest.
- Suspension cells: Daily Maintenance, passages into flasks and different scales bioreactors (25L,200L,200L).
- Effectively executed work instructions while complying with procedures and cGMP regulations.
- Applied acquired job skills and company's policies and procedures to complete assigned tasks.
- Fully trained on Cell counts, Autoclave, Laminar Flow Hood, Aseptic Techniques, EM Plating, Thermo SUM, Cell Thawing, Osmometer, Top and Floor Scales, Sartorius TC and Terumo Welders, PH and Conductivity Meter, Rockers.
- Completed SOP's and WI training in Success Factor, as well as observation, demonstration, and qualification on needed OJT's.
- Fully trained on various software's such as- PI System, Unicorn for AEX Chromatography.
- AKTA Flow kit Install, Delta V, SAP HANA for monitoring order process and work orders.
- Maintained 5S in assigned “owned area", executed preventive maintenance/calibration on needed equipment’s.
- Successfully raised and solved CAPA challenges in situations on processes when many times ended up as deviations.
Sr Formulation Technician/ Process Operator
Integra LifeSciences
Boston, MA
11.2019 - 11.2021
- Performed all Extracellular Bovine Matrix (EBM) processing steps In an ISO class 7 clean room environment
- This includes the setup, operation, cleaning, and maintenance of all clean room equipment
- Performs all EBM batch processing steps such as mixing chemicals, skin fleshing, skin cleaning and chemicals washing, and lyophilization of EBM to produce collagen-based Biotechnology Products in a regulated environment
- Responsibility: Manufacture biological Bovine-derived medical devices in a clean room environment
- Operate process and Inspection equipment
- Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches
- Pass and maintenance gowning qualifications to perform gowning requirement for ISO class 5, clean room operation or ISO class 7 clean room operations
- Accurately and completely fill out required process documentation, quality related documentation and execute within GMP and GDP guidelines
- Maintain compliance to cGMP/ISO system
- Responsible for accurately maintaining legible and accurate records, required logs, books, records, and other procedures to comply with regulatory requirements, Good Manufacture Practices (GMP), Quality systems regulations, Standard Operations Procedures (SOP's), and Health and Safety requirements
- Follow applicable Standards Operating Procedures, quality system regulations, and ISO 13485 requirements.
Education
Biology
Middlesex Community College
Lowell, MASkills
- Cell Culture
- Aseptic and Sterilization Techniques
- Good Documentation Practice (GMPs)
- Time Management
- Laboratory Safety
- Team work and Communication
- Following Instructions
- Computer Skills
- Standard operating procedures (SOPs)
- Punctual and Reliable
- Stress Tolerance
- Positive Attitude
- Quality Control
Languages
Spanish
Native/ Bilingual
English
Professional
References
References available upon request.
Timeline
Manufacturing Associate II, Cell Therapy
Bristol Myers Squibb
03.2022 - Current
Senior formulation technician
Thermo fisher science
11.2021 - 10.2022
Sr Formulation Technician/ Process Operator
Integra LifeSciences
11.2019 - 11.2021
Biology
Middlesex Community College
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