Summary
Overview
Work History
Education
Core Competencies
Timeline
Generic

George A. Brooks

Mahwah,New Jersey

Summary

Accomplished Biopharmaceutical Manager with a proven track record of leading high-performing teams in GMP-regulated environments. Skilled in aseptic manufacturing process management, operational optimization, and regulatory compliance. Experienced in promoting interdepartmental collaboration, managing deviations, and supporting employee development. Committed to delivering top-quality products and continuous process improvement.

Overview

18
18
years of professional experience

Work History

Manager

Bristol Myers Squibb
08.2021 - Current
  • Managed, trained and oversaw a team of 30+ associates in the production of blood component lots in the following areas: Isolation, cell culture expansion, harvest and cryopreservation.
  • Maximized performance by monitoring daily activities and mentoring team members ensuring the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule.
  • Collaborated with production planning and area Management to establish a daily/weekly unit operations schedule that included people, product, and material flow across multiple shifts.
  • Assisted in writing and reviewing manufacturing operating procedures to promote effective and efficient operations, that complied with cGMP requirements.
  • Opened and assisted in deviation investigations to support on-time closure of deviations and CAPAs.
  • Ensured associates executed scheduled activities on-time, in accordance with the production schedule and in a manner consistent with the safety policies, quality systems, and GMP requirements.
  • Performed administrative duties such as performance appraisals, succession planning, time card review and vacation scheduling.
  • Collaborated closely with other Shift Managers to ensure seamless pass down and communication of operational status.
  • Developed a strong company culture focused on employee engagement, collaboration, and continuous learning opportunities.
  • Achieved departmental goals by developing and executing strategic plans and performance metrics.

Lead Aseptic Operator CAR-T

Celgene/Bristol Myers-Squibb
04.2020 - 08.2021
  • Conducted training and lead a team of over 20 associates in the production of blood component lots in the following areas: isolation, cell culture expansion, harvest, and cryopreservation.
  • Instructed junior team members on protocols and procedures of each process to maximize efficiency and minimize deviations.
  • Evaluated employee skills and knowledge, providing hands-on training and mentoring to individuals with lagging skills.
  • Mentored and guided employees to foster proper completion of assigned duties while promoting productivity, compliance and commitment to patients.
  • Provided process/production related trouble shooting guidance to operators, helping to ensuring timely completion of production activities while maintaining product quality.
  • Ensured associates executed scheduled activities on-time, in accordance with the production schedule and in a manner consistent with the safety policies, quality systems, and GMP requirements.
  • Collaborated with other Team Leads and Managers to direct workflow and support manufacturing operations.

Senior Aseptic Manufacturing Operator CAR-T

Celgene/Bristol Myers-Squibb
04.2018 - 03.2020
  • Production of human blood component lots through cell culture, harvest, and cryopreservation.
  • Used aseptic technique inside a BSC (biological safety cabinet) and clean room to ensure product sterility.
  • Weighed and measured in-process materials to ensure proper quantities are added/removed.
  • Adhered to the production schedule ensuring on-time, internal production logistics.
  • Recorded production data and information in a clear, concise, format according to proper GDPs.
  • Worked in a team based, cross-functional environment to complete production tasks required by shift schedule.
  • Trained new employees and promoted supportive, performance-oriented atmosphere by, instructing each in use of lab equipment, standard operating procedures and company policies.
  • Instructed junior team members on protocols and procedures of each process to maximize efficiency and minimize deviations.

Quality Documentation Analyst

White Plains Hospital H.I
02.2015 - 03.2018
  • Performed analysis of medical records; verified that all chart completion requirements have been met for regulatory compliance and if not assigned deficiencies before releasing scanned documents into the EMR.
  • Reconciled clinical notes, patient encounter forms and health information for compliance with HIPPA rules.
  • Queried physicians and nursing staff for incomplete and/or missing documentation.
  • Utilized knowledge of ICD-10-CM and ICD-10-PCS to properly translate performed services into numerical code for insurance company reimbursements.
  • Compared incoming data against quality, integrity and accuracy expectations, identified faults and affected timely remedies.
  • Performed document reproduction, printing documents from electronic sources such as email attachments, PDF files and cloud storage.

Cell Processing Associate / Trainer

Dendreon
02.2010 - 05.2012
  • Dendreon Processed human blood cells in an aseptic clean room environment (class 10,000/ISO7 and class 100,000/ISO8).
  • Aseptic manufacturing and assembly of clinical and commercial human blood derived components in compliance with company SOP’s and FDA cGMP’s.
  • Trained new hires in aseptic manufacturing process inside cleanroom.
  • Helped design, plan and develop training documentation.
  • Batch record reviewer for manufacturing dept.
  • Reviewed batch records for corrections and completeness prior to release to QA.
  • Developed, maintained and updated SOP’s.
  • Assisted in updating paper batch record.

Packaging Line Operator

Pfizer
08.2007 - 01.2010
  • Set up, operated, monitored and cleaned packaging line equipment such as Merrill slat fillers and various boxing machines.
  • Assisted with quality and production process improvements to support new packaging initiatives.
  • Labeled, recorded and inspected packaging to prepare for shipment or storage.
  • Completed processing activities to conform with laws, safety standards and product hygiene standards.
  • Oversaw incoming packaging products and monitored quality of outgoing products to comply with specifications.
  • Observed machine operations to verify quality and conformity of packaged products, stepping in to resolve issues promptly and avoid costly production errors.
  • Enhanced workplace safety by conducting routine equipment checks and reporting potential hazards promptly.

Education

ICD-10 Medical Coding -

Westchester Community College
Valhalla, NY
02.2017

High School Diploma -

Ramapo S.H.S
Spring Valley, NY
06.1995

Core Competencies

Team Leadership & Development, Aseptic Manufacturing, GMP/GDP Compliance, Deviation & CAPA Management, Production Scheduling (BIO-G), Cross-functional Collaboration, Oracle Systems, MES, EQRMS, Epic & Meditech Applications, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)

Timeline

Manager

Bristol Myers Squibb
08.2021 - Current

Lead Aseptic Operator CAR-T

Celgene/Bristol Myers-Squibb
04.2020 - 08.2021

Senior Aseptic Manufacturing Operator CAR-T

Celgene/Bristol Myers-Squibb
04.2018 - 03.2020

Quality Documentation Analyst

White Plains Hospital H.I
02.2015 - 03.2018

Cell Processing Associate / Trainer

Dendreon
02.2010 - 05.2012

Packaging Line Operator

Pfizer
08.2007 - 01.2010

ICD-10 Medical Coding -

Westchester Community College

High School Diploma -

Ramapo S.H.S

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George A. Brooks