i

Viral Vaccine Technologist Resume Sample


Complete Name
Complete Address
Phone # / Cell Phone #
E-mail Address

Viral Vaccine Technologist

Highly-motivated and self-driven professional, offering extensive years of experience and expertise on quality development and validation of equipment and processes toward growth and advancement within vaccine/pharmaceutical field. Exemplify strong background in conducting review and analysis of protocols, reports, standard work instructions, standard operating procedures, and batch production records. Thrive at delivering excellent performance and possessing initiative, sound judgment, and strong decision making skills. Demonstrate capabilities in directing multiple teams as well as coordinating advancement and developmental programs.

Competitive Advantages:

  • Goal-oriented: Committed to delivering outstanding performance and accomplishing duties to realize initiatives in adherence with the organization’s set goals and objectives; rendering required effort to meet and exceed expectations; and utilizing full understanding of set of procedures and conducting follow through in moving a process forward
  • Customer-service: Preserve and maintain a clear, two-way communication process with customers fostering mutual expectations and service satisfaction; proactively keep the customer updated and abreast with the latest changes
  • Teamwork: Adept at collaborating with other departments and business areas
  • Innovation: Apply new ideas and applications to arrive at the best possible solution
  • Broad Knowledge Base: Acquired in-depth experience in the field which was gained from various positions held, including project lead, viral manufacturing technician, viral assay technician, and laboratory manager

AREAS OF EXPERTISE

  • Quality Operations and Validation
  • Vaccine Manufacturing Management
  • Equipment Handling
  • Production Planning
  • Process Improvement and Development
  • Leadership, Training, and Team Building
  • Performance Advancement
  • Problem Identification and Resolution

PROFESSIONAL EXPERIENCE

Sanofi Pasteur | Swiftwater, PA
Viral Vaccine Technologist | Jun 2004-Present

Regularly check and monitor the employees’ performance while on duty; render assistance in training newly hired personnel; function as backup for vacant positions; effectively organize, coordinate, setup schedule, and maintain functional areas; and delegate workloads and arrange priorities

  • Oversaw, coordinated, and monitored the training process and execution for influenza manufacturing personnel during the production of sucrose buffer for stability validation and hydrocortisone buffer for mixing validation; pulling of peak fractions, creation of Diluted Gradient Fraction Pool (DGFP,) and triton addition to ensure compliance of Fluzone high dose development manufacturing with development protocol and high dose batch production record; as well as the mixing validation for the DGFP and triton addition
  • Effectively monitored and managed influenza manufacturing personnel during 300kD Tangential Flow Filtration (TFF), as well as in measuring peak gradient fractions with in-line refractometer, pooling the peak gradient fractions (DGFP), determining optical density, adding Triton, carrying out Sorvall high-speed centrifugation (including cleaning cycle development), and inactivating influenza (including 1st inactivation, 2nd inactivation, and slurry sampling)
  • Supervised the AS&AD technicians during the preparation of reference antigen and purified HA
  • Carried out and spearheaded several validation studies, including sucrose stability, DGFP/splitting mixing, and hydrocortisone mixing; along with the execution of development studies such as grey butyl stopper effect on the buffer pH, hydrocortisone effect on influenza harvest fluid, and the effect of vial and syringe stoppers on influenza vaccine
  • Arranged and set priorities with manufacturing personnel to efficiently deliver the validation protocols
  • Rendered support to primary personnel in conducting test samples for viral inactivation, viral infectivity, bioburden, optical density, red blood cell counts, pH, and conductivity; take charge of the validation process during the absence of technicians
  • Trained the influenza manufacturing personnel focusing on proper pipetting technique and optical density determination; answered questions regarding the new inactivation procedure in influenza manufacturing, including sample pulling, measuring sample for optical density, and transferring product to a monitored tank; and provided extensive training to new viral technology employees on the usage of autoclave and proper safety precautions to be taken upon entering laboratories
  • Rendered support to Disk-Stack high speed centrifugation in influenza manufacturing and the Sorvall centrifugation or 300kD/50kD TFF
  • Monitored GE and Saint-Gobain representatives in ensuring the quality of their tubing welders and sealers, along with the Sartorius and Pall filter representatives while guaranteeing the quality of their pre-filters and sterile filters, necessary for critical processes during influenza vaccine production
  • Guided the W. B. Moore representatives into influenza manufacturing to fit the 100L jacketed tanks with the appropriate dip-tubes; supported the Analytical Science and Analytical Design personnel in utilizing the Beckman high-speed centrifuge

Perform review and evaluation of the specifications, integrating and troubleshooting new and existing equipment and processes

  • Introduced a new pump for the influenza seed fill, which requires an aseptic processing sequence (APS) prior to implementation, including a change control, validation protocol, batch production record (BPR) revision, and revision to all SWIs pertaining to the seed fill; replaced repeating processes on glass syringe for filling seed
  • Streamlined sucrose buffer hold time to 30 days ahead of schedule by writing and executing the stability protocol, compiling the data pack, and writing the corresponding report in a timely and efficient manner; significantly saved manufacturing time, money, and effort for the Influenza High Dose development lots
  • Verified and validated the mixing parameters for high dose DGFP and hydrocortisone buffer preparation, along with mixing parameters for the gelatin addition to the buffer used for influenza concentrate, pre-sterile and sterile filtration flushing
  • Developed a protocol for the small-scale hydrocortisone effect on influenza harvest fluids, along with previous lab notebook studies; summarized all data needed for the corresponding report; and generated results showing a significant increase in HA concentration in the influenza, B-strain harvest fluid
  • Maintained good working condition and ensured calibration of the following equipment: Genesys 10UV spectrophotometer, numerous micropipettors, Beckman high-speed centrifuge, safety shower, and safety eye flush
  • Prepared reports regarding alternative methods for cleaning and disinfecting viral vaccine manufacturing areas, including utilization of Vaporized Hydrogen Peroxide (VHP) against yellow fever and influenza virus; co-authored the closed container integrity study; held accountable for ensuring proper calibration of materials and equipment used in manufacturing A/California (H1N1) purified HA, reference antigen, and production seed; and carried out complete review of the B-strain BPR containing the new inactivation process in Influenza manufacturing, including the kinetics BPR for any discrepancies and formatting
  • Initiated the protocol and report for the evaluation of all cleaning reagents used against all strains/types of influenza virus vaccine manufactured throughout yellow fever and influenza manufacturing; assessed alternative methods for cleaning and disinfecting viral vaccine manufacturing areas, such as the utilization of Vaporized Hydrogen Peroxide (VHP) against yellow fever and influenza virus
  • Articulated and documented the SWI for building and integrity testing of the 100L jacketed tanks used for influenza inactivation in Influenza manufacturing

Implement changes and adjustments during ongoing process; direct daily activities and monitor critical steps of the production area by planning and assigning personnel

  • Oversaw and supervised efforts with influenza manufacturing personnel to pass A/California (H1N1) seed in order to increase the yield of each production lot, including traffic and gowning training in order to work in a BSL2+ area; designed a worked a fluid schedule to complete the manufacture of A/California reference antigen and purified HA
  • Worked with computer engineers in influenza manufacturing to tune the temperature control monitors and fix the inactivation clocks to guarantee maximum and precise inactivation process; set up the 100L jacketed tanks with pressure test for the new inactivation procedure in influenza manufacturing; and maintain cleanliness and sterilization of the tank

Assume accountability in purchasing and maintaining equipment to ensure building and product integrity

  • Provided support to several significant small-scale studies by ordering equipment and needed materials, such as standards, waste disposal containers, testing reagents/materials, and buffer reagents; partnered with other Viral Technology personnel to check and flush the safety eye-wash and shower stations located in the lab to ensure properly functionality in the case of an emergency; accurately checked chart recorders for the walk-in cooler to ensure the integrity of each sample; as well as materials and equipment needed to produce A/California purified HA, reference antigen, and production seed
  • Forged and drove efforts in order to obtain and calibrate all the equipment needed for the new inactivation procedure, such as equipment for the 100L jacketed tanks, micropipettors, temperature chart recorders, spectrophotometer units, Masterflex pump, and recirculating water baths

Promote and improved performance and cohesiveness through team meetings

  • Encouraged team development and improvement on performance through tackling influenza APS, influenza development lot, influenza validation, small-scale study, production seed, and one-on-one meeting with upper management, BPR and SWI review for influenza manufacturing, inactivation sampling and dispensing for influenza manufacturing, monthly and weekly manufacturing technology, 1st and 2nd influenza inactivation, Sorvall centrifugation cleaning, NIVMF focusing on Disk-Stack centrifugation, and manufacturing technology all-hands safety meetings
  • Organized meetings to enhance team performance through discussing A/California (H1N1) seed, reference antigen and purified HA preparation, and closed container integrity meeting

EDUCATION

Bachelor of Science in Biology, University of Scranton  Scranton, PA: 2003
Dean’s List │Inducted to National Society of Collegiate Scholars (NSCS)
Teacher’s Assistant (TA): Animal Behavior Laboratory

SELECTED TRAININGS

White Belt Introduction to Process Excellence │ Critical Aseptic Gowning Qualification │ Deviation Investigation Procedure Industrial Operations Change Control Procedure │ Control of Master Documents Procedure for Collecting, Handling, Treating and Disposal of Infectious Wastes Procedure for the Disposal of Hazardous Wastes, Waste Oils and Paints Protocol Deviation Reporting and Developmental Change Control during Qualification/Validation Evaluation for and Preparation of Biological Deviation Reports for the FDA and Stability Data Collection and Documentation for Aseptic Process Simulations for Sanofi Pasteur Inc., Swiftwa Aseptic Process Simulation Validation Requirements for the Sanofi Pasteur – US Filling Areas Qualification of Facilities, Utilities, and Equipment │ Process Validation Policy │ Process Monitoring Procedure | Manufacturing Flow Diagram for Preparation of Pandemic Influenza Subunit Virus Vaccine | Manufacturing Flow Diagram for Preparation of Influenza Split Virus Vaccine, High Dose, No Preservative Preparation of Influenza Reference Antigen │ Myers-Briggs Type Indicator LabWare Basics LWB1 │ LabWare Sample Management SMA1 │ LabWare Sample Management SMA2 Accident and Incident Investigation Part 2 │ Traffic and Gowning Regulations for Viral Vaccine Manufacturing How to Initiate Change Control │ Approval of Change Control Requests Procedure for Passage and Storage of Influenza Virus Cultures Received from Outside Sources Environmental Monitoring for Viral Manufacturing │ Operation of the Beckman GS-6 Tabletop Centrifuge Hemagglutinin Test Method for Influenza | Sucrose Density Gradient Centrifugation for the Evaluation of Viral Disruption Operation of the GENESYS Series 10 Spectrophotometer │ Operation and Maintenance of the Decontamination Autoclave Working in Enhanced BSL-2 Laboratories │ Wrapping Glassware, Equipment, and Operation of Autoclaves Anti-Influenza Antibody Titration by Hemagglutination Inhibition Assay Using Horse Red Blood Cells Procedure for the Comparison of Influenza Seed Cultures Using a Sucrose Density Gradient Method Use of a Hemocytometer for Determining Red Blood Cell Concentration | Chemical Hygiene Plan Operation of the Orion Conductivity Meter in Building 59 │ IO Change Control TrackWise Procedures U.S. FDA Guidance for Industry – Process Validation: General Principles and Practices │ Lockout Tagout │ General GMP Training HMI Training │ NAIO Q-Doc Author/Approver | NAIO Q-Doc Reviewer/Approver │ IO Change Control Trackwise Training Environmental Conservation │ H5N1 – Safety Precautions | Introduction to Statistical Process Control IO Change Control Process Training | FDA 21 CFR Part 11 General Awareness │ ID Required-Labeling and Tagging Influenza Seed Technician | Protection of Confidential Information │ Security System Use and Awareness | Ergonomics Accident and Incident Investigation │ ISO14001 Training Class │ Fire Warden Training

SAP
Request for Unplanned Activities-Independent Demand
Originator Training-Material Disposal Order (MDO) and In-Process Destruction Notification (IPDN)
SAP Navigation WBT 4.6 │ Inventory Overview │ Goods Issued-Bin to Bin

Ordering from the Warehouse
Process Order Confirmation │ Process Order Management │ Process Order Creation

AWARDS AND RECOGNITIONS

Sanofi Pasteur Safety Award for Viral Vaccine Development Laboratory

TECHNICAL SKILLS

Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, and Visio)
SAP │ Documentum (Citrix) │ eShopping │ LabWare (OASIS)

 

Leave A Comment

resume writing services for all careers