Summary
Overview
Work History
Education
Skills
Timeline
Generic

Dennis Lozada

Sunnyvale

Summary

Detail-oriented professional with strong analytical skills in stability evaluations and data analysis. Known for efficiently coordinating projects and maintaining laboratory operations, ensuring compliance and/or integrity in product development processes. Seeking opportunities in Research and Development, Biotech and Software Quality Assurance.

Overview

11
11
years of professional experience

Work History

Product Stability Analyst III

Cepheid
Sunnyvale
08.2021 - 12.2025
  • Performed analytical stability evaluations on innovative assays and lyophilized reagents to validate performance over time.
  • Prepared and implemented stability procedures (SOPs) to ensure structured and compliant study design.
  • Coordinated material forecasting and collection (kits, reagents, cells/samples) to support seamless study execution.
  • Carried out routine time-point evaluations per SOP and testing timelines to maintain study integrity.
  • Prepared and handled various samples, ensured accurate cartridge loading, and conducted assays using GeneXpert instruments.
  • Analyzed test failures, raw datasets, and reported progress to the team to ensure informed decision-making during reviews.
  • Drafted stability reports and implemented product shelf-life determinations, including dating extensions in compliance with regulatory standards.
  • Worked closely with core teams to coordinate and achieve project deliverables across functions.
  • Maintained laboratory operations, coordinated instrument calibration schedules, and escalated issues to ensure timely resolution.
  • Performed comprehensive reviews of batch records, stability documentation, and raw data to maintain integrity and reliability.
  • Performed investigative analyses, control crossovers, side testing, and accelerated studies to support troubleshooting efforts.
  • Assisted Quality Assurance with risk management document updates, data re-analysis, PDRs, and regulatory data requests.
  • Hosted data review sessions, daily management meetings, and cross-functional workshops to drive alignment and progress.

Production Test & Bulk Reagent Technician

Cepheid
Sunnyvale / Newark
05.2019 - 08.2021
  • Performed Functional Testing on WIP products.
  • Operated GeneXpert Instruments used in testing WIP samples.
  • Logged and reported test failures and send an alert when Non-conformances occur.
  • Reviewed Device History Records and Released them to QA.
  • Maintained workstation cleaned and organized.
  • Trained newly-hire technicians and introduce new processes to the team.
  • Utilized Kanban Cards for supply and stock management.
  • Performed Installation Qualification (IQ) and Operational Qualification (OQ) on new laboratory equipment and instruments.
  • Performed bulk reagent formulations to support continuous production line operations and product consistency.
  • Conducted pH analysis on bulk formulations to ensure adherence to established in-process requirements
  • Performed accurate real time documentation (MES) to ensure right first time (RFT) operations.
  • Maintained laboratory housekeeping including reagent and equipment inventory levels.
  • Recommended and implemented improvement ideas in the lab that will positively affect production efficiency, Quality and Safety.
  • Worked safely with hazardous chemicals and follow all safety policies fostering a safe work environment.

Assistant Store Manager

Walgreens
Mountain View
03.2015 - 05.2019
  • Performed and supervise daily store and pharmacy operations.
  • Understand and analyze metric pulse and identify store opportunities.
  • Conducted weekly meetings regarding store metric results.
  • Learned and manages payroll and scheduling according to store needs.
  • Encouraged and pursued team engagement.
  • Resolved issues with prescriptions and regular transactions.
  • Supported and promoted company initiatives.
  • Performed Merchandising and Sell out strategies.
  • Followed company policies and procedures.

Production Support Training Coordinator

Cepheid
Sunnyvale
04.2017 - 08.2017
  • Performed New Hire Trainings.
  • Reviewed RCOs/ECOs/DCOs and prepared training materials.
  • Followed all documentation procedures and redline documents for revision changes.
  • Trained associates with the SOP changes.
  • Learned the General Manufacturing Processes performed in different labs.
  • Generate and maintain all training records/certificates of manufacturing personnel related to manufacturing production in a timely manner.
  • Coordinated and collaborated with engineering, production supervisors and managers to ensure compliance for all training documentation.

Education

Internship - Software QA Testing

QAUber
Santa Clara, CA
06-2016

Bachelor of Science - Biology

Western Institute of Technology
Iloilo, Philippines
03-2013

Internship - Teacher

La Paz National High School
Iloilo, Philippines
02-2013

Internship - Aquaculture

SEAFDEC
Iloilo, Philippines
05-2012

Some College (No Degree) - LEAP Program (Walgreens)

Management Class For Assistant Managers
San Mateo, CA

Some College (No Degree) - Software QA Testing

Portnov Computer School
Mountain View, CA

Skills

  • Manufacturing (GMP, GDP)
  • Stability Studies
  • Data Trending and Analyses
  • Agile PLM
  • Production / Research Laboratory
  • MS Office Suites / Miro / Minitab / Power BI
  • Plan and Report Writing
  • Shelf-life Implementation and Extension
  • Troubleshooting / Issue Tracking
  • SAP / Inventory Management System
  • QMS / Design Control / ISO 13485
  • New Product Development (Assay)
  • Polymerase Chain Reaction
  • Risk Management / SFMEA
  • Continuous Improvement
  • Software Testing

Timeline

Product Stability Analyst III

Cepheid
08.2021 - 12.2025

Production Test & Bulk Reagent Technician

Cepheid
05.2019 - 08.2021

Production Support Training Coordinator

Cepheid
04.2017 - 08.2017

Assistant Store Manager

Walgreens
03.2015 - 05.2019

Internship - Software QA Testing

QAUber

Bachelor of Science - Biology

Western Institute of Technology

Internship - Teacher

La Paz National High School

Internship - Aquaculture

SEAFDEC

Some College (No Degree) - LEAP Program (Walgreens)

Management Class For Assistant Managers

Some College (No Degree) - Software QA Testing

Portnov Computer School
Dennis Lozada