Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

Manuel Martinez Sierra

Apex,NC

Summary

Forward thinking, organized and dependable upstream operations technician with 4 years of experience in the cleanroom environment. Proficiencies include mammalian cell culture, bioreactors, autoclaves, and manufacturing execution systems. Knowledgeable in the areas of in-process sampling, good manufacturing practice, and SOP adherence. Eager to contribute to success of the team and organization through enthusiasm for constant learning, growth, and excelling in the pharmaceutical industry.

Overview

6
6
years of professional experience

Work History

Associate III Harvest Large Scale Manufacturing

Biogen
02.2023 - Current
  • Perform daily manufacturing operations in cGMP environment for protein recovery derived from mammalian cell culture.
  • Develop strong automation system skills by working with process highly driven by Delta V.
  • Operation of process equipment like chamber bowl centrifuges, transfer panels, buffer tanks, centrate tanks, WFI tanks, foam break tanks, POD/STAX disposable depth filter systems, and polishing filter systems.
  • Execution of packed cell volume sampling prior to centrifugation of culture and, centrate sampling after centrifugation.
  • Monitors current process against other batches with multivariate data analysis software to visualize trends and clusters, and identify any deviations.
  • Documents and Reviews cGMP data and information for processing steps and/or equipment activities, following standard operating procedures.
  • Perform calculation for base addition, and Triton X addition for viral inactivation in accord with batch records.
  • Learned and adapted quickly to new technology and software applications.
  • Assist with execution of validation protocols for process equipment.
  • Demonstrated strong organizational and time management skills by working in fast-paced environment where multiple batches run concurrently.

BCG Vaccine Production

Merck
10.2022 - 01.2023
  • Worked in Grade A (ISO Class 5) cleanroom environment to carry out daily operational needs for production of Bacillus Calmette Guerin Vaccine.
  • Performed media fills for validation of aseptic technique and gown plating using microbiological growth medium.
  • Helped with changeovers and preparation set up for batch production.
  • Conducted acceptable quality limit sampling to ensure product quality, and patient safety.
  • Operation of autoclaves, depyrogenation ovens, washers, and ultrasonic cleaners.
  • Assisted with dynamic air and surface sampling during critical in-process activities.
  • Monitored production equipment and reviewed equipment cycle reports to determine pass/fail according to procedure criteria.

Upstream Covid Drug Substance

Merck
08.2021 - 10.2022
  • Supported manufacturing process from start up phase of project, engineering runs, and PPQ.
  • Hands on production in upstream cell culture from thawing, inoculation, expansion, additions, harvest, and lysis.
  • Set up and operation of single use WAVE bioreactors, 250 L, 1000 L, and 2000 L bioreactors.
  • Executed in-process sampling, testing, and equipment calibration according to procedures for Vi-CELL BLUE cell viability analyzer and Nova FLEX 2 cell culture analyzer.
  • Conducted media, antifoam, base, and lysis buffer additions according to bath records and production schedules.
  • Manipulated drug substance samples in biological safety cabinet for Endotoxin and Bioburden testing.
  • Reviewed PBR documentation for processing errors, identified missing data, made corrections, and followed up with team members to close out incomplete documentation transactions.
  • Trained new team members on processing procedures and on vital equipment used in processing.
  • Calibrated pH and dissolved oxygen probes prior to autoclave sterilization.
  • Safe operation and procedures of cryogenic freezers during cell bank and virus seed takeouts.
  • Became a small equipment instructor for new hires.

Clean Room Technician

Coram Specialty Infusion Services
08.2019 - 08.2021
  • Compounded adult and pediatric Total Parenteral Nutrition solutions utilizing automated compounding device and manual syringe drawing of components.
  • Followed USP 800 standards for safe compounding of Cytotoxic and Chemotoxic drugs in isolator to minimize risk of exposure to personnel and environment.
  • Combined inotropic agents with other intravenous fluids in biological safety cabinet.
  • Ensured patient safety by adhering to USP 797 by cleaning, sanitizing, and conducting preventive maintenance on compounding equipment.
  • Reconstituted antibiotics and antifungals for transfer into elastomeric pumps.
  • Assisted in annual smoke study of cleanroom to visualize airflow patterns.
  • Biannual media fills for validation of aseptic preparations and gown plating using microbiological growth medium.
  • Conducted air and surface sampling, submitted, and tracked sample results to corroborate cleanroom sterility.

Package Handler

UPS
06.2018 - 08.2019
  • Used hand-held scanners to track parcel information such as location, condition, and receipt.
  • Sorted packages into corresponding lanes as they moved along conveyor belt.
  • Communicated with floor managers to determine package placement.
  • Inspected incoming and outgoing shipments to verify accuracy and prevent errors.
  • Assembled, sealed, and loaded packages into correct trucks.
  • Followed verbal and written instructions to properly move and ship products.

Education

Associate of Applied Science - Pharmacy

Durham Technical Community College
Durham, NC
06.2020

Skills

  • Cell culture
  • Delta V, SAP, UNICORN, MES PASS X, GLIMS, Kneat, Oracle, SIMCA, TrackWise, InfoBatch, PI Vision, and CMMS
  • Set up and operation of bioreactors
  • GMP guidelines and Standard Operating Procedures
  • Batch record and log book review
  • Grade A ( ISO Class 5) gowning
  • Operation of autoclaves
  • Data collection for protocols
  • Tube welders and pumps
  • LOTO
  • BSC aseptic manipulations
  • CIP and SIP cycles for stationary equipment
  • Filter integrity testing
  • In-process sampling
  • PPQ

Languages

Spanish
Native or Bilingual

Timeline

Associate III Harvest Large Scale Manufacturing

Biogen
02.2023 - Current

BCG Vaccine Production

Merck
10.2022 - 01.2023

Upstream Covid Drug Substance

Merck
08.2021 - 10.2022

Clean Room Technician

Coram Specialty Infusion Services
08.2019 - 08.2021

Package Handler

UPS
06.2018 - 08.2019

Associate of Applied Science - Pharmacy

Durham Technical Community College

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Manuel Martinez Sierra