Summary
Overview
Work History
Education
Skills
Timeline
Generic

Paul Nobles

Somerset

Summary

Senior Operations Associate with 15+ years of pharmaceutical field experience. Dependable and detail-oriented, professional adept at quickly identifying and resolving operational issues, implementing new processes and providing exemplary customer service. Possesses excellent organizational, problem-solving, and communication skills.

Overview

17
17
years of professional experience

Work History

CAR-T Senior Operations Associate

Legend Bio-Tech
10.2022 - Current

· Perform process unit operations (i.e. cell culture, purification, aseptic processing, and cryopreservation) according to standard operating procedures and batch records, while recording production data and information in a clear, concise format.

· Perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.

· Build strong partnerships with Manufacturing, Engineering, and Quality, and work as part of a cross-functional team to complete production tasks required by shift schedule.

· Support the development of manufacturing processes and will work with others to drive continuous improvements and efficiencies within cell therapy Technical Operations.

· Trained and perform LFG (Laminar Flow Glovebox) processes daily.

· Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.

· Cross trained in harvest and wash of cells and injecting the cells with IL-2 while in G-rex in cell culture.

Head of Security

Stagehouse Tavern
07.2018 - Current

· Take proactive steps in ensuring a safe and secure environment is provided

· Perform all security duties, monitor and manage security systems

· Manage and direct overall performance of the security team which consist of 10+ employees

· Ensure that appropriate security policies, procedures and training is established and followed

Supervisor of Asset Protection

Walmart
10.2019 - 03.2023
  • Improved staff performance in handling asset protection matters through regular training sessions and workshops.
  • Conducted investigations into suspected internal thefts, leading to the identification of culprits and recovery of stolen assets.
  • Managed a team of asset protection associates, ensuring their adherence to company policies and standards.
  • Created a safe shopping environment for customers by maintaining strict access control measures at store entrances and exits.

ASEPTIC CORE MONITOR

Akorn Pharmaceuticals
04.2007 - 07.2022
  • Train production personnel on proper Aseptic gowning and related techniques
  • Perform daily visual audits of Aseptic behavior during various stages including setup, formulation, filling, and sanitization activities
  • Provide corrective training based on any visual observations made during audits
  • Document activities in logbooks and forms in a timely and legible manner as per GMP
  • Review, write and revise SOPs related to production activities
  • Maintained high levels of vigilance while monitoring multiple patients simultaneously, ensuring prompt identification of any changes in condition.

BATCH RECORD REVIEW

AKORN PHARMACEUTICALS
04.2007 - 07.2022
  • Expedited production timelines while maintaining quality standards through accurate record-keeping on batch progress.
  • Maintained accurate records, ensuring proper documentation for audits and financial reviews.
  • Maintained accurate records of all inspections, tests, audits, and other relevant data for easy access during internal or external reviews.
  • Reviewed batch records diligently, verifying accuracy before releasing products for shipment.

LEVEL IV ASSOCIATE

AKORN PHARMACEUTICALS
04.2007 - 07.2022
  • Subject Matter Expert (SME) in setting up manufacturing equipment for various products (sterile ophthalmic solutions, gels and ointments)
  • Participate in semiannual media fills
  • Troubleshoot and resolve operating difficulties, assist mechanics in any repairs of equipment
  • Perform line changeovers in a safe and efficient manner
  • Follow manufacturing instructions (Master Batch Records, SOPS) in activities which include; weighing of raw materials, compounding activities (formulation) as well as filling of product
  • Disassemble, assemble, and clean filling equipment
  • Ensure all related documentation is completed as required in a timely manner based on GMP and site SOPs (batch records, usage logbooks, forms etc.)
  • Cleaning and sanitization of equipment, compounding and filling rooms
  • Guide and train junior production associates on processes, techniques, and safety
  • (Several positions held over the course of 15 years at Akorn Pharmaceuticals in supporting production activities; Line Mechanic, Filling Operator, Compounder, Environmental Monitor)

Education

High School Diploma -

Piscataway Township High School
Piscataway, NJ
06.2006

Skills

GMP, GDP and SOP Training

Aseptic Techniques Microsoft Applications (Word, Excel, Powerpoint)

Leadership and interpersonal skills

Problem solving

Multitasking

Team Support

Timeline

CAR-T Senior Operations Associate

Legend Bio-Tech
10.2022 - Current

Supervisor of Asset Protection

Walmart
10.2019 - 03.2023

Head of Security

Stagehouse Tavern
07.2018 - Current

ASEPTIC CORE MONITOR

Akorn Pharmaceuticals
04.2007 - 07.2022

BATCH RECORD REVIEW

AKORN PHARMACEUTICALS
04.2007 - 07.2022

LEVEL IV ASSOCIATE

AKORN PHARMACEUTICALS
04.2007 - 07.2022

High School Diploma -

Piscataway Township High School
Paul Nobles