Biotech Manufacturing & QA Specialist
Resume:
Elaine Vaghar
Bedford, MA *****
******.******@*****.***
SUMMARY
Experienced Biotech Manufacturing Associate and Quality Assurance with a successful track record in delivering optimal results for Fortune 500 pharmaceutical and biotechnology companies. Skilled in cGMP environments, upstream and downstream processing, documentation control, and team training. Technical proficiency in a wide range of equipment and software systems.
Areas of Expertise
• Small and Large Scale Operations, Aseptic Technique, 12K Bioreactors CIP (Clean-In-Place)
• Pressure Hold (PH), SIP (Steam-in-Place), End to End Process. • Equipment Prep & Autoclaving
• Chromatography Skids • GMP/cGMP Compliance • Document Control • SAP, LIMS, EDMS
• Laboratory Equipment (Akta Skid, Nanodrop, Centrifuge) • Training & Supervision
EXPERIENCE
Moderna Therapeutics – Norwood, MA
Senior Manufacturing Associate (2023 – Present)
Start up the DNA Plasmid Department.
Execute production of plasmid DNA processes: fermentation (upstream) and purification (downstream).
Support document revisions, material management via SAP, and lab equipment operations (SUF, Akta Skid, Nanodrop, centrifuges, CTUs, FIT).
Train new and junior staff in procedures and protocols.
Work independently under minimal supervision.
Organize and participate in team briefings and meetings, such as Quality Assurance Group and Safety Team.
Arranta Bio – Watertown, MA
QA Specialist (2022 – 2023)
Supported cGMP operations through document control and lot number assignment.
Reviewed document change requests in EDMS for completeness and compliance.
Collaborated with stakeholders on documentation timelines and delivery.
Ensured timely review/approval of documents and managed feedback integration.
Maintained document control room and managed record requests/archiving.
Supported internal/external audits and continuous improvement initiatives.
Senior Associate I (2021 – 2022)
Operated fermenters and performed seed train, harvest, and plasmid DNA purification.
Prepared media/buffers and assembled materials per production schedule.
Identified and escalated deviations; contributed to investigations.
Provided updates across cross-functional teams.
Takeda Pharmaceuticals (formerly Shire) – Lexington, MA
Manufacturing Associate Technician II (2018- 2021)
Operated in Cell Culture and Purification following cGMP standards.
Conducted thawing/inoculation into 500L–2000L bioreactors; performed viral inactivation, chromatography, and TFF.
Used SAP, PAS, UNICORN, and LIMS systems.
Troubleshot processes and revised batch records/logbooks.
Provided team support and escalated issues as needed.
Sanofi Pharmaceutical (Formerly Genzyme Corporation) – Allston, MA
Manufacturing Associate technician (2012- 2018)
Executed production in ISO 5 cleanroom environments using LFH and BSC.
Performed cell culture scale-up (thaw to 2000L), daily monitoring/sampling, filter testing, autoclaving, and equipment prep.
Operated bioreactors and participated in process from inoculation through purification.
Trained team members, authored/revised SOPs, and utilized multiple systems (e.g., SAP, ILIMS, Delta-V, RS-3).
Pfizer Pharmaceuticals (formerly Wyeth) – Andover, MA
Senior process technician (2007 – 2012)
Maintained cell culture processes and inoculum preparation for FIX/BMP production.
Managed inventory using SAP and operated equipment (spinners, bioreactors, filters, centrifuges, chromatography systems).
Conducted harvest operations with ultra-filtration skid systems.
Shire Pharmaceuticals – Cambridge, MA
Production Control associate (2006 – 2007)
Operated Cell Mate robotic systems for roller bottle culture operations.
Maintained sterile environments, monitored cultures, logged records, and ensured quality compliance.
SKILLS
Equipment & Tools: Bioreactors (12K, 6K, 500L), Chromatography Systems, TFF, Autoclaves, SUF, Akta Skid, CTUs
Software: SAP, ILIMS, EDMS, PAS, UNICORN, RS-3, Delta-V, APEX, ERP, Microsoft Office, Plateau
Documentation: GMP Documentation, SOP Writing/Revision, Batch Records, Training Materials
Compliance: cGMP, QA/QC, Document Control, Audit Support
EDUCATION & TRAINING
Worcester Polytechnic Institute (WPI) – Worcester, MA
Training in Biotechnology
Massachusetts Biotechnology Council – Boston, MA
Biotechnology Project Management Training
Boston University – Boston, MA
Certificate in Biotechnology and Clinical Science
Middlesex Community College – Lowell, MA
Practical Biotechnology Training (in conjunction with Boston University)
Escola Superior de Educação Física do Estado de Goiás – Goiânia, Brazil
B.S. in Physical Education
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