Summary
Overview
Work History
Education
Skills
Key Accomplishments
Accomplishments
Languages
Timeline
Generic

RYAN BALLINA

Easton,PA

Summary

Award-winning QC Microbiology Specialist II with 5+ years of expertise in microbiology, quality assurance, and regulatory compliance. Recognized with the prestigious 2025 Carvykti President's Award for pioneering MALDI-TOF implementation, delivering $1M in site cost savings. Adept in sterility testing, growth promotion, aseptic techniques, and cleanroom operations. Proven leader in cross-functional collaboration, process mapping, and data integrity initiatives that drive continuous improvement and audit readiness.

Overview

5
5
years of professional experience

Work History

QC Microbiology Specialist II

Legend Biotech
Raritan, NJ
04.2025 - Current
  • Responsible for Raritan-site Growth Promotion for TSA, RODAC, SDA, and APQ testing.
  • Working with management and process engineers on process mapping for MALDI-TOF, data criticality, and SOP revisions.
  • Spearheaded the in-house implementation of MALDI-TOF, earning the 2025 Carvykti President's Award - reducing site costs by $1M annually while improving turnaround time and throughput.
  • Led Desiccation Study Project (3-4 Hour Intervals), to test TSA Settle Plate desiccation across multiple BSCs at higher laminar flow velocities.
  • Fostered cross-functional collaborations with QA Micro and Validation teams to streamline Growth Promotion testing protocols.
  • Cultivated a collaborative team environment through open communication and mentorship, contributing to project success and morale.

QC Microbiology Specialist I

Legend Biotech
Raritan, NJ
06.2023 - 04.2025
  • Conducted EM sampling in cGMP cleanroom environments, ensuring ISO compliance and enhancing data integrity for improved audit readiness.
  • Operated Bac-T machine to optimize bacterial detection conditions, ensuring greater accuracy and reliability.
  • Proficient in Gram staining techniques for bacterial classification and morphology analysis.
  • Performed rigorous data reviews in strict adherence to ALCOA+ principles, identifying anomalies and validating data integrity.
  • Initiated Non-Conformance (NC) reports to document deviations and support CAPA process implementation.
  • Collaborated cross-functionally to streamline project timelines and enhance outcomes.

Environmental Monitoring Team Lead / Senior Associate

Bristol Myers Squibb (Contract)
Summit, NJ
09.2022 - 03.2023
  • Supervised team of ~15 in routine and investigative environmental monitoring sampling, ensuring compliance with standards.
  • Conducted investigative air sampling during air reversals, verifying compliance with regulatory standards and AHS effectiveness.
  • Utilized CeLabs software for sample tracking, data analysis, and team collaboration.
  • Collaborated with engineering teams to enhance environmental control measures, contributing to improved operational efficiency.

Quality Assurance Specialist

QuVa Pharma
Bloomsbury, NJ
03.2022 - 09.2022
  • Conducted QC sampling for endotoxin, potency, sterility, and particulate matter testing to verify product safety and quality.
  • Aseptic-gown qualified; executed Environmental Monitoring (EM) sampling in cleanroom environments to ensure compliance during compounding procedures.
  • Performed GEMBA walkthroughs to assess and reinforce adherence to QA procedures among employees.
  • Coordinated with DEA specialists on controlled substance accounting and reverse distribution compliance.

Quality Assurance Technician

QuVa Pharma
Bloomsbury, NJ
08.2021 - 03.2022
  • Conducted AQL inspections during labeling and packaging; partnered with management to create effective training methodologies.
  • Enforced GMP systems, validated processes, and ensured adherence to SOPs and documentation standards.
  • Executed post-compounding procedures and ensured safe API waste disposal according to theoretical yields.
  • Ensured safe, hazard-free work environment while fostering health and safety awareness.

Education

Master of Science - Industrial and Systems Engineering

University of Oklahoma
Norman, OK
05-2027

Bachelor of Arts - History

Florida International University
Miami, FL

Associate of Arts - Business Administration

Miami Dade College
Miami, FL

High School Diploma -

Terra Environmental Research Institute
Miami, FL

Skills

  • Process mapping
  • Data analysis
  • Quality assurance
  • Environmental monitoring
  • Process optimization
  • Continuous improvement
  • Workflow automation
  • Project planning

Key Accomplishments

  • 2025 Carvykti President's Award - MALDI-TOF Implementation, Led the end-to-end initiative to bring MALDI-TOF microbial identification in-house at the Raritan site, eliminating costly third-party testing contracts. Achieved a $1M reduction in site expenditures within a single fiscal year while simultaneously decreasing sample turnaround time and significantly increasing testing throughput - enabling the site to support accelerated production timelines for the Carvykti cell therapy program.
  • Desiccation Study Project - Designed and executed a study to evaluate the desiccation of TSA Settle Plates under 3-4 hour intervals under elevated laminar flow velocity conditions across multiple biological safety cabinets for Raritan-site expansion. Performed all associated growth promotion testing, compiled and analyzed results, and authored a comprehensive executive summary documenting methodology, findings, and recommendations for site-wide implementation.

Accomplishments

2025 Carvykti President's Award- MALDI-TOF Implementation

Languages

English
Native/ Bilingual
Spanish
Native/ Bilingual
French
Professional
German
Limited

Timeline

QC Microbiology Specialist II

Legend Biotech
04.2025 - Current

QC Microbiology Specialist I

Legend Biotech
06.2023 - 04.2025

Environmental Monitoring Team Lead / Senior Associate

Bristol Myers Squibb (Contract)
09.2022 - 03.2023

Quality Assurance Specialist

QuVa Pharma
03.2022 - 09.2022

Quality Assurance Technician

QuVa Pharma
08.2021 - 03.2022

Master of Science - Industrial and Systems Engineering

University of Oklahoma

Bachelor of Arts - History

Florida International University

Associate of Arts - Business Administration

Miami Dade College

High School Diploma -

Terra Environmental Research Institute
RYAN BALLINA