Summary
Overview
Work History
Education
Skills
Training
Timeline
Generic

Fabian Barona

Lebanon,New Jersey

Summary

Dedicated bio-pharmacuetical manufacturing technician with a proven track record of exceeding performance expectations. Specialized in aseptic techniques within ISO 5 cleanroom environments, ensuring stringent compliance with GMP and GDP standards. Extensive experience in executing complex manufacturing processes, particularly in the realm of CAR-T therapies. Demonstrated expertise in developing and refining batch records, SOPs, and BOMs to enhance operational efficiency. Strong adaptability and leadership skills showcased through successful execution of multiple manufacturing runs, including APS, Engineering, and R&D studies. Committed to continuous improvement, I bring a keen attention to detail and a collaborative spirit to contribute to team success. My background reflects a passion for precision, compliance, and the advancement of bio-pharmaceutical manufacturing, particularly in the exciting field of CAR-T therapies.

Overview

12
12
years of professional experience

Work History

Manufacturing Technician II

Catalent Pharma Solutions
11.2022 - 07.2023
  • Exceeded performance expectations as a bio pharma manufacturing technician at Catalent
  • Successfully learned and executed the HSV process from current client for developing CAR-T process involving monocytes, demonstrating adaptability and attention to detail.
  • Traveled to Houston for training to learn processes and perform clinical trials in order to train the team back in New Jersey during tech transfer.
  • Played a key role in developing and refining batch records, SOPs, and BOMs for cross-functional processes
  • Transferred and integrated SOPs from previous business entities, contributing to a seamless transition
  • Trained manufacturing department as a qualified trainer in HSV processing, emphasizing effective knowledge sharing and skill development
  • Created training records in adherence to HSV process requirements for aseptic level techniques and material handling. Training also required all manufacturing technicians to read and understand all SOP for equipments as well as training directly with equipment (Welder/Sealer, Elutra, Centrifuge, Cryopreservation in CRF and Cryo tanks, Max Cyte, Viable Cell Count with Via2 Cell counter, Pipetting, Cellstacks, BacT sampling, etc.)
  • Led the execution of 6 APS runs, 8 Engineering runs, and various R&D and clinical batches with minimal cleanroom contact
  • Ensured strict adherence to GMP and GDP standards, maintaining ALCOA boundaries in all processes
  • Assisted creating the MBR for our client by transferring over to a new layout and reevaluating for better understanding of process.
  • Enhanced product quality through meticulous monitoring of manufacturing processes and regular review of all batch records and training records.
  • Emphasized clear communication, teamwork, and individual efforts for effective organization and work importance.
  • Improved production efficiency by implementing standardized procedures and streamlining workflow.
  • Committed to contributing to team success and actively seeking opportunities for personal and team growth.

Manufacturing Operator

Bristol Myers Squibb
03.2021 - 10.2022
  • Car-t manufacturing team member specializing in Selection Bucket (Apheresis Handling DAY 0)
  • Trained and qualified on various materials and equipment (Sealer, Welder, Sepax, Clinimacs, etc.)
  • Proficient in collecting viable cell count samples via cellometer, balance use, and cryopreservation
  • Executes aseptic techniques in cleanroom wearing garments and personal protective equipment gowning into ISO 7 classified cleanrooms handling materials in GMP areas using ventilators
  • Daily tasks involve cGMP understanding, working with batch records/log books, and adherence to SOPs
  • GMP qualified in SOPs based on requirements, controls, and cell therapy for Selection, Cryopreservation, and Activation processes
  • Collaborates with cross-functional departments (MSAT, QASF, QC, Warehouse) for production tasks
  • Reviews logbooks and Master Batch Records, ensuring compliance with Good Documentation
  • Maintains ALCOA+ guidelines for proper GDP
  • Familiar with MES and Oracle executions
  • Skilled in operating various equipment (Sepax, Cellometer, CliniMACS, Plas,atherm, Dynamag, TSCD Welder, Tube Sealer, Xuri Bioreactors, etc.)
  • Manages completion, review, and archival of batch records and logbooks
  • Execute day-to-day projects with precision and accuracy (e.g., word documents, spreadsheets, powerpoints)

Patient Support Center Team Lead – Inbound

Hearing Life
09.2019 - 02.2021
  • Team lead for Inbound Customer Service
  • Responsible for a team of 20+ in Customer Service relations
  • Duties include: oversight of agents receiving calls, monitoring live/current status of agents throughout the day, live monitoring/assisting agents with patients over the phone, reviewing data reports of agents for; calls handled, call duration, calls abandoned, average call time/handle time, average wait time, and abandoned calls
  • Trained new employees to understand all processes and expectations for their positions, including remote training capabilities/software maintenance while onboarding prior to building a full remote team
  • Maintained scheduled 1 on 1’s with all agents to review performance and to improve data report for calls throughout the day and best practices for creating new and concrete opportunities for patient appointments
  • With scheduled 1 on 1’s we review call audit’s that are randomly picked to review and scored on a grading scale to show performance
  • Improved team productivity by implementing efficient project management strategies and streamlining communication channels.
  • Enhanced overall team performance by providing regular coaching, feedback, and skill development opportunities.
  • Involved in de-escalation of irate patients and finding solutions with open communication within the clinics and including Area DM’s & VP’s when necessary
  • Side duties include maintaining the structure of the landmark sheet for all clinics under HearingLife branch and locator tool for all agents to use for reference when assisting with patients
  • Created processes, scripts, and began the structure of SOP’s for agents to follow to better understand their positions/duties.
  • Integrated Remote work during Covid Pandemic and ran a functional team as a stand in supervisor while work productivity was being assessed.
  • Created remote program in order to work from home during the pandemic while working side by side with VP of Hearing Life to ensure work was being maintained properly.

Patient Support Center Representative

Hearing Life
06.2019 - 02.2021
  • Call Center Scheduling Assistant for Hearing Life
  • Responsible for booking appointments for current and new patients
  • In charge of making outbound calls to clinics spread throughout the country, as well as receiving inbound calls and supporting patients with hearing needs
  • Strong understanding of how the company sells Hearing Aids and confident working with the Diary Management program in order to make appointments
  • Enhanced company reputation by providing exceptional customer service and support.
  • Competitive selling environment; reaching dials per day/appointments per day and managing to maintain an above average count consistently.

Insurance Agent

Plymouth Rock & Prudential
01.2019 - 05.2019
  • Assisted customers with information for obtaining insurance
  • Customer Service oriented, cold calls, lead sheet for potential and recurring customers
  • Office Administration work to organize files and clients.

Sales Associate

Guitar Center
11.2017 - 08.2018
  • Provided excellent customer service to all guitar center customers
  • Regular procedures included (not limited to) answering phone calls daily for customer support, working on extensive green screen program provided by the company, filing customer names for Lessons/Rentals, email/word documents/photocopies/faxing for all customers who were processing through the store for extensive reasons, maintained warehouse protocols for inventory stock, and overall interpersonal connections with all customers
  • Recognized for advanced knowledge in Pro Audio, lead in Pro Audio
  • Assisted with problem solving for all products.
  • Increased sales revenue by building strong rapport with customers and recommending appropriate products based on their needs.
  • Boosted customer satisfaction levels through exceptional service, addressing concerns promptly, and providing a welcoming store environment.

Food Runner Lead, Room Service

Bridgewater Marriott Hotel/Marriott International
01.2012 - 01.2015
  • Provided Room Service for guests, morning and afternoon
  • Held responsible to withstand guests accommodations, food requirements, allergy information
  • Lead within Kitchen Staff
  • Responsible for counting money at the end of shifts to tally up tips/requisites for the day and relay that information to our accountant team to manage finances within the hotel
  • Exceeded in customer service within the restaurant and throughout the hotel
  • Signed off deliveries sent to the hotel and helped manage inventory.

Front Office

Bridgewater Marriott Hotel/Marriott International
01.2012 - 01.2015
  • Helped guests check in, received guests at door and helped with luggage, provided assistance to any guests or employer at the hotel, held knowledge of Hotel and Hospitality for guests
  • Assisted guests check into their hotel rooms and accommodate guest needs in an appropriate and timely manner
  • Provided full customer service for all prospects of the hotel; managing data of all guests, documenting all protocols for hotel, working with word/emailing outside providers of hotel, problem solving for any issue directed with the front desk, quick and adaptive environment.

Education

Some College (No Degree) -

Berklee College of Music
Boston, MA

Some College (No Degree) -

Raritan Valley Community College
Branchburg, NJ

High School Diploma -

Immaculata High School
Somerville, NJ
06.2012

Skills

  • Proficient in aseptic techniques within ISO 5 cleanroom environments, ensuring the highest standards of bio pharmaceutical manufacturing
  • Demonstrated expertise in executing complex manufacturing processes with a focus on bio pharmaceutical and cell therapy
  • In-depth knowledge of GMP and GDP standards, ensuring compliance with ALCOA boundaries for documentation integrity
  • Skilled in developing and refining batch records, SOPs, and BOMs to enhance operational efficiency and cross-functional collaboration
  • Bilingual in English and Spanish, handy in French
  • Proficient in Microsoft Word/PowerPoint/Excel
  • Skillful with Mac interfaces
  • Highly Organized, Strong attention to detail, and Dedicated to team success

Training

GMP Qualification, Lean Six Sigma trained (White Belt and Yellow Belt), Aseptic Techniques, SOP Development and Refinement, Equipment Operation, Process Training, Compliance and Documentation Integrity.

Timeline

Manufacturing Technician II

Catalent Pharma Solutions
11.2022 - 07.2023

Manufacturing Operator

Bristol Myers Squibb
03.2021 - 10.2022

Patient Support Center Team Lead – Inbound

Hearing Life
09.2019 - 02.2021

Patient Support Center Representative

Hearing Life
06.2019 - 02.2021

Insurance Agent

Plymouth Rock & Prudential
01.2019 - 05.2019

Sales Associate

Guitar Center
11.2017 - 08.2018

Food Runner Lead, Room Service

Bridgewater Marriott Hotel/Marriott International
01.2012 - 01.2015

Front Office

Bridgewater Marriott Hotel/Marriott International
01.2012 - 01.2015

Some College (No Degree) -

Berklee College of Music

Some College (No Degree) -

Raritan Valley Community College

High School Diploma -

Immaculata High School

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Fabian Barona