Summary
Overview
Work History
Education
Skills
Timeline
Generic

Anthony Mitchell

Rosedale,MD

Summary

Dynamic and results-driven technician with over 20 years of experience in the pharmaceutical industry, demonstrating a proven track record in executing qualification protocols for new and existing equipment. Expertise in developing and implementing process improvements rooted in Lean Six Sigma and Operational Excellence initiatives, complemented by strong aseptic training capabilities for filling technicians and comprehensive knowledge of current cGMP regulations. Committed to generating optimal results through a positive work ethic, high energy, and a continuous desire for professional growth. Seeking a position that enhances existing skills while fostering further development and advancement within the industry.

Overview

2026
2026
years of professional experience

Work History

Downstream Supervisor

Wuxi/Minaris Advanced Therapy
10.2023 - 07.2025
  • Hold 1 on 1 with the team
  • Maintain Vacation calendar to give approval for request.
  • Work closely with client on developing their process
  • Work closely with QA to train on SOP revisions batch record completion
  • SME on new equipment and perform training to make others qualified to train on new equipment.
  • Request and Review of batch records once they were issued for production.
  • Perform on the floor review of the batch record during production.
  • Review of batch records once they were completed to address any corrections (if needed) prior to records going to QA for final review.
  • Responsible for new hire on boarding to ensure they have access to the learning systems and have the required training set up for them in (elms) Electronics Learning Management Systems.
  • Revise and Create SOPs to keep current with cGMP and GDP
  • Perform SAP transaction of all materials used for processing.
  • Perform cycle count and inventory adjustments as needed or at the end of the month/
  • Initiate CAPAs and DV if needed, perform investigation for DV to come to a final resolve.

Downstream Supervisor

Endo Pharmaceuticals
06.2021 - 12.2022
  • Work closely with calibration to schedule equipment that was due for calibration.
  • Perform new equipment qualifications, execute IQ/OQ and PQ for new equipment.
  • SME on new equipment and perform training to make others qualified to train on new equipment.
  • Review of batch records once they were completed to address any corrections (if needed) prior to records going to QA for final review.
  • Responsible for new hire on boarding to ensure they have access to the learning systems and have the required training set up for them in (elms) Electronics Learning Management Systems.
  • Revise and Create at least 5 SOPs a month to keep current with cGMP and GDP
  • Initiate CAPAs and DV if needed, perform investigation for DV to come to a final resolve.

Downstream Manufacturing Lead/Supervisor

Emergent Bio Solutions
05.2020 - 05.2021
  • Attend daily Tier meetings at 0600 and 1800 to give updates on the current process
  • Responsible for new hire on boarding to ensure they have access to the learning systems and have the required training set up for them in (elms) Electronics Learning Management Systems our training system.
  • Revise SOPs to keep current with cGMP and GDP
  • Initiate CAPAs and DV if needed, perform investigation for DV to come to a final resolve.
  • Responsible for planning and scheduling of the team for all sides of Downstream (Weigh and Dispense, Buffer Prep, Assembly Prep and Processing)
  • Oversee a 2 shift operation for 4 areas of downstream (3 different MFG areas and our Weigh and dispense)
  • Hold 1 on 1 with the team
  • Maintain Vacation calendar to give approval for request.
  • Work closely with validation on implementation of new equipment
  • Work closely with calibration to schedule equipment that was due for calibration.
  • Request and Review of batch records once they were issued for execution.
  • Review of batch records once they were completed to address any corrections (if needed) prior to records going to QA for final review.

GMP Purification MA III / Fil Finish MA III

Paragon Bio Services
01.2018 - 05.2020
  • Hold daily Tier meetings with the Fill team
  • Schedule for 12 Buffers to be made for multiple clients
  • Schedule area clearance for 2 different production room to be used and the Aseptic fill suite
  • Perform RTR (Real Time Review) of 6 batch records as well as end of production review
  • Revise client batch records for simplicity and improve process time
  • Act as lead in the Purification GMP Manufacturing operations
  • Leverages knowledge and application of the theories and principles utilized to solve operational, as well as routine tasks in the purification of proteins, antibodies, etc. for Phase I/II GMP manufacturing
  • Works closely with purification management to initiate new manufacturing projects and helps develop processes/techniques to meet contract objectives
  • Perform buffer preparations, in-process sampling, formulation of bulk drug substance
  • Conducts changeover and activation procedures for clean room suites and equipment
  • Submits in-process and cleaning samples to QC with required documentation
  • Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps
  • Generates operational protocol(s), internal or external documents (SOPs, BRs), deviations and summary reports
  • Working closely with various departments and offers assistance as needed
  • May work in process development at times to transfer purification projects into GMP
  • Interacts with clients during manufacturing campaigns and audits
  • May lead in conducting the GMP and Safety training of manufacturing staff
  • Implemented new training program for the Downstream department
  • Other duties as assigned

Biopharmaceutical Manufacturing Associate – Cell Culture Value Stream (CCVS) Downstream

GlaxoSmithKline
03.2015 - 01.2018
  • Titrate, filtrate, inoculation and pH adjustments of cells for Purification and Final Formulation
  • Maintain accurate documentation within cGMP regulations while executing production batch records. Preform pre QA review of all batch documents prior to final QA review.
  • Formulate and transfer buffer production solutions to be used for the next part of processing.
  • Receiving of Cell harvest using an automated production Delta V program.
  • Knowledge or axichrom column to extract out the needed proteins and performing resin change out after so many uses.
  • Perform purification operations through column storage to planova filtration to manual TFF filtration to final fill.
  • Use of single use system from 200L up to 500L
  • Communicate with other shifts to ensure proper and clear shift change and issues that may have happened.
  • SAP/MERP, CDMS, Track wise and LIMS trained for sample submission, inventory control and SOP revisions
  • Participate in making the production area in a state of audit readiness.
  • Stand by company values and behaviors, as well as, communicate the values with new employees.
  • Stream line process to decrease batch record size and redundancy in recording information and the need for a verifier when computer captured the verifier.
  • Implemented Ergonomic improvements that cut production time and eliminated 80% of ergo issues such as bending, stretching and kneeling.
  • Assist with calibration of flow meters, pressure release valves, scales and other production critical equipment

Supervisor

Gallus Biopharmaceuticals
02.2013 - 11.2014
  • Effectively communicated with clients regarding their needs and the execution of their product.
  • Communicated and operated across different departments such as Validation, Quality Control and Quality Assurance to ensure all materials needed for production were approved and released.
  • Performed batch record training and subsequent on-the-floor review of batch records throughout each and every day.
  • Develop Tech Transfer Process for new clients.
  • Developed departmental Training Metrics with new employees.
  • Stream lined client process to capture only the critical steps and created WI (work instruction) that detailed the process.
  • Filling Associate II
  • Worked with FP filler and West Capping machine in an aseptic area.
  • Revamped media qualification for filling technicians
  • Revamped aseptic qualification, and implemented aseptic observation check list
  • Working with single use Bioreactors bags from 200L up to 1000L
  • Used axichrom column storage to extract proteins and performed resin change out after so many uses
  • Troubleshot issues regarding FP filler and West Capping machine in the aseptic area.
  • Made decisions based on current cGMP procedures and business needs to determine best action for each preposition.
  • Delegated team member tasks based upon daily operations scheduled and performed batch formulations.
  • Performed calibrations on scales, timing feeders and pressure cappers
  • USM MFG Associate II
  • Performed aseptic vial thaw for scale up processing.
  • Efficiently performed manual cell counts and counts using Cedex MS20 C Automated Cell Counter.
  • Using small scale table top mixing and 20L bio bags and wave tables for cell growth
  • Transcribed, reviewed, and closed different deviations within the department.
  • Maintained deviation tracking spreadsheet to optimize the results of processing.
  • Reviewed batch records prior to and after execution of the batch/process.
  • Performed formulation of Medias for scale-up production.
  • Performed various integrity tests of filters used during processing implementations.
  • Performed the set-up of Cronos filter trains used for production.

Lead Manufacturing Technician

IGI Laboratories
01.2011 - 01.2012
  • Efficiently performed daily compounding activities incl. chemical verification, equipment check, sanitization of 12 pieces of equipment per Batch Record
  • Maintained and reviewed Sanitization of 24 different log books for the Quality Control department
  • Reviewed and revised Standard Operating to comply with current cGMP
  • Responsible for the daily cleaning and sterilization of the manufacturing area and equipment

Manufacturing Technician III

Medimmune LLC
01.2003 - 01.2011
  • Successfully conducted deviation investigations and developed necessary corrective and preventive actions in Track Wise
  • Performed manufacturing related SAP transactions
  • Stream lined Aseptic process and implemented an aseptic observation check list and gowning video.
  • Assisted in mapping out new manufacturing suit for upgraded Inova filling machine
  • Assisted in going overseas to qualify new filler
  • Implemented filling technician qualification with new filler using RABS system (restricted access barrier system)
  • Provided oversight to production line to ensure quality measures were met prior to start-up
  • Reviewed and revised production-related SOPs via electronic data management system (Aegis) to ensure that we maintained cGMP, FDA and OSHA regulations
  • Initiated CAPAs to improve process and prevent product loss
  • Responsible for executing IQ/OQ on all new equipment to be implemented into the manufacturing area
  • Performed Environmental Monitoring (EM) in controlled areas; including total particulate count, airborne particulate, surface bio-burden and personnel plating
  • Metrology Technician
  • Performed basic calibration on various types of equipment including entering/maintaining data on the Blue Mountain Calibration Management system
  • Efficiently scheduled and prepared equipment for calibration with contracted vendor
  • Calibrated manufacturing instruments (i.e. pressure, temperature, mass, conductivity, humidity)
  • Reviewed Calibration data from off-site contractors and in-house personnel.
  • Scheduled Calibration in conjunction with production to reduce downtime.
  • Performed IQ/OQ on new equipment for aseptic process
  • Multiple calibration equipment used; Fluke, Druk, Kaye Validator

Liquid Mixing Operator

McNeil Consumer Specialty Care
1993 - 01.2002
  • Prepared dry chemicals for weekly scheduled batches
  • Maintained database when transitioning prepared chemicals from inventory
  • Prepared tanks with liquid chemicals necessary for production and label all prepared chemicals
  • Line Tender
  • Ensured that all packaging components were in place
  • Performed daily Quality Assurance testing during production
  • Attended to and resolved any minor malfunctions of production line
  • Maintained SAP database for staged product and served as group super-user
  • Transitioned finished product from packaging line to warehouse and prepared for shipping
  • Obtained Forklift operator certification

Education

Project Management Professional Certification -

Becker College
08.2025

Lean Six Sigma Green Belt Training

Rutgers University
Camden NJ

Vocational Technical High school -

Murrell Dobbins Area
Philadelphia, PA
01.1986

Skills

  • Planning and Scheduling
  • Strong communication and origination skills
  • Leadership Skills
  • Training and Mentoring
  • Aseptic Technique/Processing
  • Multi-tasking and managing
  • Communication/Writing Skills, Quality Assurance
  • Lean Six Sigma /OE methodologies
  • Problem Solving (5W’s and H)
  • Process Developments and Improvements
  • Meeting deadlines

Timeline

Downstream Supervisor

Wuxi/Minaris Advanced Therapy
10.2023 - 07.2025

Downstream Supervisor

Endo Pharmaceuticals
06.2021 - 12.2022

Downstream Manufacturing Lead/Supervisor

Emergent Bio Solutions
05.2020 - 05.2021

GMP Purification MA III / Fil Finish MA III

Paragon Bio Services
01.2018 - 05.2020

Biopharmaceutical Manufacturing Associate – Cell Culture Value Stream (CCVS) Downstream

GlaxoSmithKline
03.2015 - 01.2018

Supervisor

Gallus Biopharmaceuticals
02.2013 - 11.2014

Lead Manufacturing Technician

IGI Laboratories
01.2011 - 01.2012

Manufacturing Technician III

Medimmune LLC
01.2003 - 01.2011

Liquid Mixing Operator

McNeil Consumer Specialty Care
1993 - 01.2002

Project Management Professional Certification -

Becker College

Lean Six Sigma Green Belt Training

Rutgers University

Vocational Technical High school -

Murrell Dobbins Area

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Anthony Mitchell