Summary
Overview
Work History
Education
Skills
Timeline
Generic

Luke Pothen

Westwood,NJ

Summary

Detail-oriented and highly motivated Biomedical Engineering graduate with hands-on experience in GMP-regulated environments. Strong foundation in documentation, compliance, and quality assurance. Consistently demonstrates ability to support cross-functional teams and effectively manage sample logistics. Close coordination with QA/QC ensures data integrity and adherence to regulatory protocols. Excellent communication skills enable effective engagement with stakeholders while managing shifting project priorities. Clinical operations knowledge and site coordination experience make me an ideal candidate for a Clinical Research Associate (CRA) role.

Overview

4
4
years of professional experience

Work History

Manufacturing Associate

Bristol Myers Squibb
09.2024 - Current
  • Execute CAR-T cell therapy manufacturing processes in ISO 7/ISO 5 cleanrooms, ensuring strict adherence to cGMP and GDP standards
  • Coordinate with QA/QC to manage timely sample handoffs, batch documentation, and compliance audits
  • Record and track batch data to maintain data integrity and traceability; contributed to zero deviation performance

Routinely participated in gowning evaluations and personnel plating; supported seamless collaboration across QA/QC/Production teams

Secretary, Southeast Regional Youth Fellowship

Mar Thoma Church
01.2023 - Current
  • Led multi-state youth coordination initiatives for 200+ attendees; strengthened communication across regional teams
  • Built engagement strategy that improved virtual reach by over 35% using targeted content and scheduling

Research Assistant

CNA Lab, NJIT
06.2022 - 10.2023
  • Assisted in developing a neural network using DeepLabCut to detect and track gait movement underwater for rehabilitation research.
  • Applied data analysis techniques to improve research quality, resulting in a 20% increase in data collection accuracy and 15% improvement in analysis rate.
  • Secured a $500 Undergraduate Student Research and Innovation Seed Grant, used to enhance lab capabilities and experiment depth.
  • Contributed to research documentation, testing protocol adjustments, and collaborative lab meetings.

Lifeguard Supervisor

Lifetime Fitness
05.2021 - 09.2023
    • Oversaw 3 pool sites and a team of 10+ lifeguards to enforce safety protocols and site readiness
    • Created and maintained safety documentation; enforced daily compliance and responded to emergent issues with clarity

Volunteer

Global Health Organization
03.2023 - 03.2023
  • Helped set up and operate pop-up clinics; ensured documentation compliance for 1,168 patients
  • Assisted with sterilization, setup, and service coordination under time-sensitive, high-impact conditions

Education

B.S. - Biomedical Engineering, Business

New Jersey Institute of Technology (NJIT)
Newark, NJ
05.2024

Skills

  • GMP and GDP compliance
  • Clinical site coordination exposure
  • Sample tracking and handling
  • Microsoft Office (Word, Excel, PowerPoint)
  • Data integrity
  • ISO 5/7 cleanroom gowning
  • Batch documentation
  • Cross-functional collaboration (QA/QC/Production)
  • Verbal and written communication

Timeline

Manufacturing Associate

Bristol Myers Squibb
09.2024 - Current

Volunteer

Global Health Organization
03.2023 - 03.2023

Secretary, Southeast Regional Youth Fellowship

Mar Thoma Church
01.2023 - Current

Research Assistant

CNA Lab, NJIT
06.2022 - 10.2023

Lifeguard Supervisor

Lifetime Fitness
05.2021 - 09.2023

B.S. - Biomedical Engineering, Business

New Jersey Institute of Technology (NJIT)
Luke Pothen