Technical Support Process Validation and Improvement

ANASTASIA GIANNAS

www.linkedin.com/in/anastasia-giannas *********************@*******.***

SUMMARY

Highly skilled science and engineering professional with 6 years of experience and expertise in metallurgy, biomedicinal chemistry, and pharmaceuticals, holding extensive knowledge acquired from both the US and EU. PROFESSIONAL EXPERIENCE

PROCESS VALIDATION ENGINEER/CONSULTANT – Aphena Pharma Solutions, Inc. (Nov 2021 – Dec 2024)Easton, MD, USA

• I was responsible for the process validation of private label products, which generated approximately one million dollars in monthly revenue. My focus was exclusively on the manufacturing floor operations for the chocolate laxative product line. This line was instrumental in producing all chocolate laxative products distributed in the United States by several prominent consumer retailers.

• I provided direct technical support to ensure the reliability and compliance of manufacturing processes for cosmetics, medical devices, prescription and OTC drug products, dietary supplements, and animal health products. This support involved the validation of equipment to be used, along with manufacturing processes, as well as the development of work instructions and procedures (MBRs) for contract customer projects (as CMO), all in accordance with ISO 22716 and 9001 standards.

• Developed and implemented protocols, as well as executed reports, for the validation and verification processes related to cleaning, blending, filling, packaging, labelling, and serialization. This work was carried out within the Technical Services and Validation Department while simultaneously collaborating with the Quality, Analytical, Microbial, Project Management, Maintenance and Operations departments.

• Created and prepared protocols and summary reports for operational qualifications, engineering studies, and process transfers and scale-ups.

• Prepared, reviewed, and approved technical documentation as required, which includes SOPs, Change Controls, CAPAs, deviation investigations, MBRs, PPQs, SPQs and other procedures. Additionally, I aided with the documentation of FATs, SATs, IQs, OQs, and PQs write-ups.

• Conducted a thorough investigation and resolution of manufacturing issues that contributed to production delays and technical complications. This was achieved through the execution of a risk assessment report, root cause analysis, and systematic problem-solving methodologies.

• Led and participated as a team member in initiatives aimed at enhancing processes within the production area. These initiatives included conducting experiments in the analytical chemistry and microbiology laboratories, as well as performing modelling and data analysis related to production to improve process control, yield, purity, and productivity.

• Engaged in the identification and summarisation of improvement opportunities within technical reports through the application of statistical analyses, gap analyses, plant trials, investigations, research activities, laboratory trials, and the modelling of processes and unit operations.

• Utilized applied scientific principles to evaluate the formulation of cosmetic, medical device, and pharmaceutical products, paying careful attention to the interactions among chemistry, equipment, processes, and closed container systems.

• I completed R&D pilot blend batches for customer projects and assisted with the reformulation of existing products, aiming to mitigate any risks or issues that may arise during the compliant manufacturing process.

• Executed a comprehensive review of SDS for raw materials utilised in various processes for operational safety and prepared a SDS for newly developed private label products.

ANDROLOGY LABORATORY TECHNICIAN (PART TIME) – Shady Grove Fertility (Oct 2020 – Aug 2022) Towson, MD, USA

• Worked in the fertility healthcare industry, where I managed the acceptance of patients and conducted sample processing for Intrauterine Insemination (IUI) and Artificial Insemination by Donor (AID) procedures. This work was performed in accordance with cGLP and cGCP guidelines.

• Received and assessed patient samples using a chain of custody for processing.

• The results of the recorded and validated patients were documented through the generation of a formal report intended for the physician or medical assistant responsible for the patient's transfer.

• Maintained inventory and database of frozen sperm in cryopreservation tanks.

• Completed preventative maintenance, calibration, and daily quality control assessments for lab instruments and reagents.

• Documented repair/calibration services for lab equipment and reagents as required by the Joint Commission on the Accreditation of Healthcare Organizations (JHACO).

• Supported in the recording, validation, and maintenance of embryology cryogenic tanks. Responsible for charging liquid nitrogen tanks, as well as arterial blood gas, oxygen, and nitrogen gas tanks as required.

• Lastly, I trained new laboratory technicians during their weekend shifts. Anastasia Giannas

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MICROBIOLOGIST/LABORATORY TECHNICIAN/INTERN - Noxilizer, Inc (Mar 2020 – Nov 2021) Hanover, MD, USA

• I was a member of the Product Development team, which was responsible for the comprehensive manufacturing of Noxilizer's medical devices, including Biological Indicators (BIs), Self-Contained Biological Indicators (SCBIs), Process Challenge Devices (PCDs), and Chemical Indicators. This work adhered to ISO 13485, 11138, and 11140 standards, as well as cGMP and cGLP.

• Daily operations involved conducting steam NO2 sterilization cycles for medical devices and combination products at the Biological Indicator Evaluation Resistometer (BIER) Unit, also referred to as the NOX Unit. Following these cycles, characterization was performed in the microbiology laboratory through microbial growth population checks and/or the HSK process. The NO2 sterilization method served as an in-vitro model of the human body's response. The process validation for the NO2 sterilization method adhered to ISO 14937 and ISO11135.

• The population of the biological indicator lots were evaluated through a population verification and enumeration procedure, adhering to the standards established in USP 61 and USP 62 with respect to colony-forming units (CFU) and inoculum.

• R&D activities were conducted at the NOX Unit, where sterilization cycles were tailored to meet the microbial requirements of the medical devices being manufactured. Subsequently, the NOX data analysis was evaluated alongside FTIR analysis to determine the optimal concentration of NO2 and make necessary adjustments to Humid Air conditions.

• Assisted with Analytical Equipment Validation, IQ, OQ, and PQ of laboratory equipment and apparatus, such as sterilizer gas tank, FTIR and BIER system.

• The batches of Geobacillus stearothermophilus spores received were characterized by cytometry to evaluate their cell properties, which established the parameters for the NO2 sterilization cycles.

• I prepared and mailed petri dishes for third-party result verification and distributed consumables to pharma customers. I also handled documentation for tracking orders and customer information.

• Assisted in developing documentation for SOPs, PSPECs, WIs, and Test Plans while maintaining records of studies conducted in a laboratory notebook.

• At the end of the consumable cycle of R&D and product development, helped with the preparation of official Certificates of Analysis and Certificates of Compliance prior to their distribution to B2B customers.

• Carried out monthly environmental monitoring (EM) within the laboratory setting to assess the sterility of equipment, including biological safety cabinets (BSCs), as well as the overall environment.

• Colorimetric assays were executed to quantitatively measure sterilant residuals extracted from medical devices or processed materials.

• Lastly, I was responsible for training fellow laboratory personnel on essential laboratory tasks and guiding them in the meticulous practice of proper GDP. This experience not only enhanced our operational efficiency but also fostered a culture of excellence and attention to detail within our team. CHART SCANNER – Endoscopy Center of North Baltimore (Mar 2019 – Feb 2020) Towson, MD, USA

• I contributed to the quality categorization and organization of patient charts and records, including scanning the charts into a national database, which supports registered nurses in evaluating patient conditions at the Document Control office.

• I accurately inputted patient and insurance information into the company's system and updated the chart records to maintain precise and comprehensive documentation.

EDUCATION

Université de Bordeaux Bordeaux, France

Certificate: MAterials to Technologies for Advanced Energy Storages (MATES) Certificate: Gender Equality and Diversity in Academia Aalborg University (AAU) Aalborg, Denmark

MSc, Major: Engineering (Materials and Nanotechnology with specialisation in Materials Technology) University of Maryland, Baltimore County (UMBC) Baltimore, MD, USA BSc, Major: Chemistry, Minor: History, plus Certificate: Human Context of Science and Technology Community College of Baltimore County (CCBC) Baltimore, MD, USA A.A.Sc, Major: Engineering Technology (Electro-Mechanical specialisation) University of Manchester Manchester, UK

Integrated Foundation Year in Engineering and Physical Sciences Rhodian Pedia School General Private Lyceum Rhodes, Greece Apolytirion of General Lyceum, Major: Technological specialisation: Information Technology & Services UNIVERSITY PROJECTS

Pitting Resistance Study after the Laser Forming of AISI 304 Stainless Steel and its Remediation Methods of Chemical Pickling and Laser Ablation Processes Individual Research (Thesis, Aalborg University) Anastasia Giannas

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CERTIFICATES

o Lean Six Sigma Green Belt Professional (by Six Sigma Global Institute) May 2024 o Process Improvement Specialist (by Six Sigma Global Institute) Apr 2024 o Project Management (by International Business Management Institute) Feb 2024 o Mini-MBA (by International Business Management Institute) Mar 2023 o Lean Six Sigma Yellow Belt Certificate (by Six Sigma Global Institute) Oct 2022 RELEVANT COURSEWORK

§ Analytical Chemistry

§ Advanced Instrumental Methods

§ Biomedicinal Chemistry

§ Organic Chemistry

§ Toxicological Chemistry

§ Inorganic Chemistry and Lab

§ Physical Chemistry and Lab

§ Physics and Chemistry of Surface

§ Strengths and Materials

§ Fluid Power

§ Engineering Processes & Methods

§ Mechanics and Maintenance

§ Troubleshooting Mechanical

Systems

§ Computational Modelling

§ Materials Characterization

§ Advanced Materials Science &

Physical Metallurgy

§ Polymers and Polymer Composites

(Mechanics of Composites)

§ Solid Mechanics with

Microstructure

§ Principles of Electronics and

Electricity

§ Hazards Recognition and Control

(OSHA)

§ Principles of Project Management

SKILLS

Laboratory: Biological Indicator Evaluation Resistometer (BIER), Microbiology Lab Skills, Sterile And Aseptic Techniques, Plating Bacteria Samples And Counting Plates, Heat Shock Colony Growth Promotion, Streak Plate Method, Coating Biological Indicators, Pipetting Techniques, Simple & Fractional Distillation, Steam Distillation, Cytometry, Viscometry, Calorimetry, Titrations, FTIR Spectroscopy, Raman Spectroscopy, NMR, Recrystallization, Extraction, Thin Layer And Column Chromatography, Absorption Spectrophotometry, GC, HPLC, Cyclic Voltammetry, Cyclic Polarization, Cyclic Loading (Fatigue), Microscope Operation, Photochromism, Photoluminescence, Electric Circuits, Tensile Test, Electrochemical Impedance Spectroscopy(EIS), X-Ray Diffraction

(XRD), Ellipsometry, Atomic Force Microscopy (AFM), Differential Scanning Calorimetry (DSC), Creep Test, Atomic Layer Deposition (ALD)

Programs: ArcGIS, AutoCAD, Avogadro, Gantt Project, Gates DF-Pro, JMP, LaTeX, Microsoft Office Suite, NI Multisim, OPUS, Toup View, Wolfram Mathematica, MATLAB, Python, Visual Studio Code Languages: Modern Greek (native fluency), English (native fluency)

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