Marlen Quintana
San Diego,CA
Summary
Manufacturing professional with extensive experience in GMP processes, aseptic operations, and early-stage cell therapy development. Skilled in batch record authoring, process optimization, deviation investigations, and cross-functional collaboration. Proven ability to identify process gaps, implement innovative solutions, and consistently meet project deadlines while maintaining regulatory compliance.
Overview
7
7
years of professional experience
Work History
Senior, Manufacturing Associate
Artiva Biotherapeutics
San Diego, CA
06.2022 - Current
- Developed, optimized and revised Manufacturing documents, including Manufacturing Batch Records (MBRs), Equipment Procedures (EQT), Standard Operating Procedures (SOP), Standard Forms (SFM), and Work Instructions(WRK).
- Developed and authored Manufacturing batch records (MBRs) for Aseptic Process Validations (APVs) and Aseptic Operator Qualifications (AOQs).
- Partnered with Materials Management and Quality Assurance to create and submit material data sheets and specification forms for GMP material enrollment.
- Collaborated with Process Development during early-stage development and optimization of feeder cells, master cell banks (MCB), and drug product.
- Executed AOQs, APVs, Smoke Studies, Engineering Runs, Developmental Studies, Gowning Qualifications, Environmental Monitoring Performance Qualifications (EMPQs)
- Conducted deviation investigations and performed root cause analyses (RCA) using the 5M method, and supported development and implementation of CAPAs.
- Expert on the operation for the following equipment: Miltenyl CliniMACS Prodigy, LOVO Cell Processing System, NC 200 Nucleocounter, Sartorious Biostat 50L Bioreactor, SKAN Pure2 Isolator, Crystal Pure M1 Filler, Control Rate Freezer, Barkery Plasmatherm, ThawStar, and Sartocheck 5 Plus.
- Owed the creation and lifecycle management of bill of materials (BOMs) for all batch records, updating them as processes evolved.
- Led cross-functional efforts with Materials Management to define and implement kitting processes for GMP bill of materials (BOMs)
- Directed investigations and collaborated with cross-functional departments to address low cell growth obstacles impacting master cell bank.
- Served as a subject matter expert (SME), guiding and mentoring new associates on standard operating procedures (SOPs) and best practices for GMP processes and equipment to enhance operational efficiency and compliance.
- Led ordering and procurement of GMP materials and equipment, ensuring timely availability to support manufacturing operations.
- Created and managed daily manufacturing process schedule, improving cross-functional communication between manufacturing and supporting departments.
- Contributed to the initial setup and configuration of GMP manufacturing space, and supported reconfiguration efforts to align with updated EU compliance regulations.
- Served as Chemical Hygiene Officer on safety committee, overseeing development of safety procedures.
Manufacturing Associate III
NKGEN Biotech
Santa Ana
03.2021 - 05.2022
- Aseptically process Whole Blood, Leukapheresis, PBMCs and NK cells in a Grade A/B (ISO5) Biosafety Cabinets in ISO7 cleanroom.
- Perform all tasks associated with the manufacturing of clinical drug product following instructions in standard operating procedures (SOPs), protocols, test records, training records and batch records.
- Perform manual cell counts, error free calculations of cell concentration and dilutions.
- Operator for processing equipment such as; Incubators, Pipette controller, Microscope, Hemocytometer, MidiMACS LS columns, (BSC) Biosafety Cabinet, Tube Sealer, Bead bath, -80 Freezer and Liquid Nitrogen tank.
- Execute Engineering, Stability, Verification and Comparability runs.
- Adhere and maintain aseptic technique practices during processing of products to ensure the integrity, viability, and sterility of finish drug product .
- Review and help with the developing of Standard Operating Procedures (SOPs).
- Executed Deviation Investigations/ Root Cause Analysis (RCA) utilizing Fishbone Diagram and 5 Whys.
- Assist MFG leads and Senior Associates with sustaining inventory levels of supplies and monitor and track trends to identify gaps.
Cell Therapy Specialist I
Kite Pharma A Gilead Company
05.2019 - 03.2021
- Perform all tasks associated with the manufacturing of clinical and commercial product following batch records and SOPs as Production.
- Produce cell growth media in the ISO7 and ISO5 areas using aseptic/sterile techniques.
- Execute cryopreservation using controlled rate freezer and cryogenic freezer for excess T-cells and final product (CAR T cells) following cGMP protocols.
- Conduct and troubleshoot filter integrity test using StartoCheck
- Collaborated with quality control department to inspect and identified defects in final product before cryopreservation.
- Oversee the safety of employees by being an EHS Representative
- Cooperated with the EHS department to improve the safety of all employees by submitting safety safety suggestions, near-misses, and attending monthly safety council meetings.
- Performed all manufacturing tasks using PAS-X Manufacturing Execution System (MES) and Oracle software.
Education
Bachelor of Science - Biochemistry
California State University
Long Beach, CA12.2018
Skills
- GMP Manufacturing and Aseptic Operations
- Process Development and Optimization
- Quality and Compliance
- Equipment and Technical Expertise
- Organization and Project Management
- SME Leadership and Mentorship
- Communication and Collaboration
- Critical Thinking and Gap Resolution
- Deadline-Driven Execution
- Skilled in Microsoft Word, Excel, and Power Point
Timeline
Senior, Manufacturing Associate
Artiva Biotherapeutics
06.2022 - Current
Manufacturing Associate III
NKGEN Biotech
03.2021 - 05.2022
Cell Therapy Specialist I
Kite Pharma A Gilead Company
05.2019 - 03.2021
Bachelor of Science - Biochemistry
California State University