KPANA JORDAN
Northborough
Summary
Detail-oriented Manufacturing Support and Quality Specialist with 12 years in biopharmaceutical operations within GMP-regulated environments. Expertise in Manufacturing Technical Support, Quality Management Systems, deviation investigations, and continuous improvement initiatives. Collaborated with cross-functional teams to enhance technology transfer, process improvements, and regulatory compliance in DNA, mRNA, Fill Finish, sterile, and purification operations.
Overview
13
13
years of professional experience
Work History
Technical Specialist, Manufacturing
MODERNA INC.
Norwood
06.2025 - Current
- Supported Manufacturing Technical Support activities for mRNA operations by conducting medium- and high-level deviation investigations, implementing CAPAs, and supporting change controls within cGMP environments.
- Developed and revised SOPs, technical reports, study documentation, and manufacturing procedures supporting commercial readiness initiatives.
- Collaborated with Manufacturing, Engineering, Validation, Quality, and MS&T teams to troubleshoot manufacturing issues, improve operational efficiency, and maintain established timelines.
- Participated in risk assessments, continuous improvement projects, and process optimization initiatives supporting manufacturing performance.
- Assisted with equipment qualification and validation activities supporting manufacturing operations.
- Supported process knowledge transfer and operator training initiatives.
- Utilized FMEA, RCA, and data-driven methodologies to identify root causes and implement corrective actions.
- Supported real-time batch monitoring and in-process controls to improve manufacturing reliability and compliance.
- Worked independently while managing multiple priorities in a fast-paced GMP environment.
Batch Specialist, Manufacturing
MODERNA INC.
Norwood
04.2023 - 06.2025
- Served as a cross-functional quality partner supporting batch review, investigations, CAPA execution, deviation management, and audit readiness activities within DNA, mRNA, and Fill Finish operations.
- Reviewed electronic and master batch records to ensure compliance with cGMP requirements and Good Documentation Practices (GDP).
- Authored deviations and CAPAs supporting manufacturing operations and investigation activities.
- Participated in root cause investigations and implementation of corrective and preventive actions.
- Revised SOPs, manufacturing procedures, and controlled documentation in accordance with Quality Management System requirements.
- Generated technical protocols, reports, and manufacturing documentation.
- Supported internal and external audit activities and inspection readiness initiatives.
- Maintained compliance with 21 CFR Part 11 requirements and electronic batch record systems.
- Worked cross-functionally to support commercial manufacturing objectives and timely investigation closure.
Manufacturing Lead, Purification
SANOFI
Framingham
11.2021 - 04.2023
- Led downstream purification operations including chromatography, UF/DF, tangential flow filtration, depth filtration, and buffer preparation within cGMP environments.
- Collaborated with Quality Assurance, Quality Control, Engineering, Validation, and Manufacturing teams to support production objectives.
- Performed in-process analytical testing including pH and conductivity analysis.
- Utilized DeltaV, SAP, and manufacturing systems to support operations and process improvements.
- Supported troubleshooting activities and continuous improvement initiatives.
- Maintained compliance with SOPs, FDA regulations, and GMP requirements.
Senior Manufacturing Associate, Purification
INSIGHT GLOBAL / SANOFI
Framingham
11.2020 - 11.2021
- Executed downstream purification activities including chromatography, filtration, buffer preparation, and solution preparation in accordance with GMP standards.
- Performed in-process testing and maintained manufacturing documentation.
- Collaborated with QA, QC, Engineering, and Validation teams to improve manufacturing performance.
- Supported troubleshooting activities and operational improvements.
- Maintained compliance with SOPs and regulatory requirements.
Manufacturing Technician, Purification
SHIRE HGT / TAKEDA
Lexington
06.2014 - 01.2020
- Supported clinical and commercial purification operations including chromatography, UF/DF, tangential flow filtration, and depth filtration.
- Operated GE Chromatography Skids, UF/DF Systems, Millipore Mobius Systems, Spectrometers, pH Meters, and Conductivity Meters.
- Performed batch record review and initiated deviations using TrackWise.
- Entered and maintained manufacturing data within SAP and LIMS systems.
- Recorded manufacturing activities in logbooks and batch records.
- Performed CIP/COP activities and equipment sterilization procedures.
- Assisted with assembly, disassembly, and maintenance of manufacturing equipment.
- Conducted analytical testing including A280, pH, and conductivity measurements.
- Supported safe manufacturing practices and regulatory compliance initiatives.
Quality Control / Quality Assurance Technician
RANDSTAD ENGINEERING / KEURIG
Burlington
03.2014 - 06.2014
- Conducted product packaging analysis, quality inspections, and testing activities.
- Recorded observations, interpreted results, and communicated findings to management.
- Supported troubleshooting and root cause investigations.
- Evaluated product performance through temperature, pressure, volume, and packaging testing.
- Ensured compliance with SOPs and quality standards.
Assistant Laboratory Technician
MIDDLESEX COMMUNITY COLLEGE
Bedford
09.2013 - 01.2014
- Prepared laboratory media and solutions to support experiments and research.
- Assisted with autoclaving glassware and biohazard waste to ensure safety and compliance.
- Facilitated daily operations in biology, microbiology, chemistry, and anatomy laboratories.
- Maintained laboratory cleanliness, organization, and readiness to facilitate efficient workflow.
Education
Bachelor of Science - Biomedical Laboratory & Clinical Sciences
Boston University School of Medicine
Boston, MAAssociate of Science - Biotechnology
Middlesex Community College
Skills
- cGMP compliance
- GDP compliance
- Regulatory compliance
- QMS administration
- Change Control Management
- Deviation analysis
- CAPA management
- Root Cause Analysis (RCA)
- Risk assessment
- Audit readiness
- Batch record review
- SOP management
- Protocol development
- Technology transfer
- Market readiness
- Validation assistance
- Equipment qualification
- Process improvement
- LIMS
- Microsoft Excel
Additional Relevant Experience
- More than 12 years supporting GMP-regulated biopharmaceutical manufacturing operations.
- Over 3 years of direct experience supporting QMS documentation, investigations, deviations, CAPAs, batch reviews, and audit activities.
- Experience supporting commercial readiness, continuous improvement initiatives, and manufacturing process optimization.
- Proven ability to manage changing priorities while maintaining timelines, quality standards, and regulatory compliance.
- Strong oral, written, and interpersonal communication skills with demonstrated success collaborating across cross-functional teams.
Technical Systems
- TrackWise
- SAP
- MES
- LIMS
- DeltaV
- Microsoft Office Suite
Timeline
Technical Specialist, Manufacturing
MODERNA INC.
06.2025 - Current
Batch Specialist, Manufacturing
MODERNA INC.
04.2023 - 06.2025
Manufacturing Lead, Purification
SANOFI
11.2021 - 04.2023
Senior Manufacturing Associate, Purification
INSIGHT GLOBAL / SANOFI
11.2020 - 11.2021
Manufacturing Technician, Purification
SHIRE HGT / TAKEDA
06.2014 - 01.2020
Quality Control / Quality Assurance Technician
RANDSTAD ENGINEERING / KEURIG
03.2014 - 06.2014
Assistant Laboratory Technician
MIDDLESEX COMMUNITY COLLEGE
09.2013 - 01.2014
Bachelor of Science - Biomedical Laboratory & Clinical Sciences
Boston University School of Medicine
Associate of Science - Biotechnology
Middlesex Community College