Summary
Overview
Work History
Education
Skills
Additional Skills - Software Lab Proficiency
Timeline
Generic

LESLIE SANTUO

Baltimore

Summary

A dedicated chemist and immunologist with experience in cGMP-regulated manufacturing, lab testing, and FDA audits. Proficient in pharmaceutical instrumentation, including AKTA Ready, AKTA Pilot 600R, Planova (Viral Filtration), TFF Skids, and assays such as ELISA, qPCR, RT-PCR, and HPLC, as well as flow cytometry, immunohistochemistry, and RNA isolation. BSL-3 certified (SARS-CoV-2 and M. tuberculosis) with cleanroom experience. In addition to my scientific expertise, I own a personal training business, where I've successfully managed sales, client acquisition, and business operations, showcasing my adaptability and entrepreneurial skills when job opportunities in my field were limited.

Overview

4
4
years of professional experience

Work History

Associate Scientist

AstraZeneca
01.2023 - 07.2023
  • Primary duties include performing GMP testing
  • Work schedule includes shift work (weekends and/or evening)
  • Performs selected quality control testing activities, dependent upon assigned area, including the following:
  • Responsible for conducting in process and finished product testing according to standard operating procedures
  • Complete appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks, and inventory forms
  • Enters data evaluated for compliance to specifications and reports abnormalities
  • Calibrates and maintains laboratory equipment according to standard operating procedures
  • Maintains lab instrumentation according to maintenance schedules
  • Maintains supply levels to support performance of assigned duties
  • Reads, understands, and follows SOP's and complies with cGMP's
  • Applies critical thought to solving problems
  • Applies knowledge of good manufacturing practices and good laboratory practices daily
  • Adheres to Company safety procedures and guidelines daily
  • Follows all safety regulations as indicated in the Policies and Procedures
  • Performs laboratory testing as assigned and per schedule
  • Maintains training greater than 95% completed on time, with 100% completed prior performing any related analysis, etc
  • Executes tech transfer and other studies for basic/platform laboratory test methods
  • Able to plan and carry out laboratory operations efficiently and effectively
  • Able to maintain accurate records of all experiments and data
  • Critical thinking and attention to details
  • A team player and customer oriented
  • QC or GMP experience a plus
  • HPLC, capillary electrophoresis, ELISA, or bioassay desired
  • Self-motivated
  • Multi-tasking, excellent written and oral communication skills desired

Immunologist

National Institute of Allergy and Infectious Disease (NIAID)
01.2022 - 01.2023
  • Assisted in conducting experiments to better understand the immune response to Mycobacterium tuberculosis in the macaque animal model
  • Performed a wide variety of procedures and techniques including, but not limited to: cell culture, clinical/diagnostic microbiology, DNA analysis, DNA isolation, DNA purification, DNA sequencing, flow cytometry, gene cloning, manipulation of radioactive isotopes, natural product isolation, organic synthesis, peptide synthesis, protein analysis, RNA isolation
  • Processed primate and murine tissue and samples for downstream applications
  • Performed flow cytometric cell sorting and/or analysis of research scientist-supplied samples
  • Maintained detailed records of experiments and their results and prepared the information resulting from these experiments for presentations at laboratory-wide, NIH-wide, and national and international meetings and for publication
  • Performed quality control and decontamination of the various laboratory spaces
  • Generated laboratory records to support laboratory research, and independently perform necessary calculations
  • Wrote reports of findings, stating methods and procedures, including any modifications employed, specimens and materials involved, and results of experiments
  • Interpreted, evaluated, and discussed the results of each experiment with the supervisor as part of the planning process for subsequent studies, and presented these findings in individual weekly meetings with supervisor as well has lab group meetings
  • Maintained responsibility for laboratory upkeep and routine maintenance of equipment
  • Maintained laboratory supplies and equipment including chemicals, biological materials, etc
  • Required to handle biological materials, carcinogens, recombinant protein materials, acids, biological wastes

QC Data Reviewer

Catalent Gene Therapy
03.2021 - 10.2021
  • Performed detailed data review for test results on assays such as ELISA, DNA/RNA extraction and gel electrophoresis, qPCR, RT-PCR, HPLC, Capillary Electrophoresis, Bioburden, endotoxin, TOC, and membrane filtration testing, generated by QC Department for compliance with cGMP, internal SOPs, and Specifications, to support production, stability studies, and lab operation
  • Reviewed Release and Stability data, trend charts of reference standards, lab equipment calibration records, logbooks, and performed other review functions as needed
  • Performed detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy
  • Compiled data results in accordance with SOPs and QC best practices
  • Maintained and updated relevant SOPs for data review and reporting as needed and worked with analysts to complete any corrections to data notebooks
  • Ensured that suitable written records and work undertaken were kept in accordance with cGMP and company procedures
  • Received and organized Batch Records and completed Test Records and paired completed Test Records with associated Batch Records
  • Communicated and responded to inquiries from internal departments regarding status of results

QC Analyst II

Emergent BioSolutions
09.2020 - 03.2021
  • Performed testing as required to support method verification/validation and material & supplier qualification
  • Wrote studies and reports to support investigations, supplier qualifications, and validation/verification studies
  • Inspected incoming raw materials and performed sampling for release testing
  • Coordinated testing and shipments of samples with contract testing laboratories
  • Performed identification, assay and limit testing of raw materials and packaging components to support manufacturing requirements
  • Became well versed in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, HPLC and GC
  • Documented laboratory work consistent with GxP requirements
  • Maintained laboratory records and inventory for standards, reagents and laboratory supplies
  • Performed preventative and corrective maintenance on laboratory equipment
  • Wrote clear and concise SOPs
  • Adhered to all effective SOPs and safety requirements

Biopharmaceutical Technician (Downstream)

Catalent Gene Therapy
11.2019 - 09.2020
  • Performed Processing Steps and/or Manufacturing Support activities, monitored processes against the batch record
  • Documented/Recorded cGMP data and information for processing steps and/or equipment activities, following standard operating procedures - key documentation included batch records and equipment logbooks
  • Performed the weighing, dispensing of raw materials for media and buffers
  • Performed the preparation of small and large volume media and buffer solutions, filtration and transfer of product
  • Operated bench top equipment including pH, conductivity, peristaltic pumps, filter integrity testers etc
  • Performed dispensing, labeling, transfer/staging of raw materials and parts
  • Maintained equipment, area and cleaning logbooks
  • Authored/reviewed/improved SOPs, batch records, protocols and technical reports - actively participated in training activities, managing their individual training plans
  • Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area
  • Completed Batch Production Records under cGMP, and documented in detail through the use of SOPs and BPRs for the processes and manufacturing steps
  • Generated operational protocol(s), internal or external documents (SOPs, BRs) and summary reports
  • Performed troubleshooting of process and equipment problems
  • Worked with Facilities and Validation to maintain manufacturing equipment
  • Recommended equipment and other supply purchases within the production areas
  • Worked closely with production management for current and new manufacturing projects and helped develop processes/techniques to meet contract objectives and avoid operational delays
  • Interacted with clients during initial and subsequent manufacturing campaigns
  • Developed experience with downstream biologic production processes under Good Manufacturing Practices (GMPs) compliance
  • Acquired great understanding and knowledge of isolating and purifying proteins from microbial and cell culture processes
  • Developed experience with chromatography equipment, columns, TFF, CIP procedures and of processes to purify bulk proteins, antibodies, etc
  • (Planova, CIMQ, Affinity)
  • Gained experience with AKTA Ready and AKTA Pilot 600R

Contractor - Operation Tech 1 (Repository)

ThermoFisher Scientific
07.2019 - 10.2019
  • Maintained responsibility for the daily pulling of infectious and non-infectious reagents from storage, packaging of reagents, and shipping using the FedEx Power ship system and other courier processes as appropriate
  • Additional responsibilities included: receiving third party shipments and preparing receiving records; aliquoting bulk reagents (weighing chemical compounds and aliquoting liquid reagents) and assembling reagent sets; assisting in updating inventory databases; ordering, unpacking and stocking supplies; and biohazard waste removal
  • Processed and handled human/animal blood, serum, urine, feces, hair, and nails
  • Organized and carefully tracked client clinical studies and Bulk drug substances
  • Pulled reagents from different storage conditions (ambient, +4, -20 walk-in, -80, and LN2)
  • Received shipments, prepared detailed receiving records, aliquoted bulk reagents/compounds and assembled reagent sets
  • Received dry ice shipments and answered calls for loading dock deliveries
  • Updated inventory databases (InTrak and Nauticlas) when needed
  • Applied Good Manufacturing Practices in all areas of responsibility

Education

B.S. - Chemistry, Minor in Biology

Shenandoah University
Winchester, VA
05.2019

Skills

  • Microsoft Office Suite
  • DataTel
  • Excel
  • Titrations
  • Western Blot
  • ICP
  • HPLC
  • Dissections
  • Chromatography
  • InTrak
  • Nauticlas
  • P-drive
  • Freezer Case System
  • Affinity
  • Unicorn
  • Planova (Viral Filtration)
  • Cytek SpectroFlo
  • FlowJo
  • BSL-3
  • BD FACS DIVA
  • Immunohistochemistry
  • Centrifuge
  • Pipetting (all aseptic techniques)
  • Dilution/Making buffers
  • Antibody Staining

Additional Skills - Software Lab Proficiency

  • Microsoft Office Suite
  • DataTel
  • Excel
  • Titrations
  • Western Blot
  • ICP
  • HPLC
  • Dissections
  • Chromatography
  • InTrak
  • Nauticlas
  • P-drive
  • Freezer Case System
  • Affinity
  • Unicorn
  • Planova (Viral Filtration)
  • Cytek SpectroFlo
  • FlowJo
  • BSL-3
  • BD FACS DIVA
  • Immunohistochemistry
  • Centrifuge
  • Pipetting (all aseptic techniques)
  • Dilution/Making buffers
  • Antibody Staining

Timeline

Associate Scientist

AstraZeneca
01.2023 - 07.2023

Immunologist

National Institute of Allergy and Infectious Disease (NIAID)
01.2022 - 01.2023

QC Data Reviewer

Catalent Gene Therapy
03.2021 - 10.2021

QC Analyst II

Emergent BioSolutions
09.2020 - 03.2021

Biopharmaceutical Technician (Downstream)

Catalent Gene Therapy
11.2019 - 09.2020

Contractor - Operation Tech 1 (Repository)

ThermoFisher Scientific
07.2019 - 10.2019

B.S. - Chemistry, Minor in Biology

Shenandoah University

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