Abigail Simon Email & Phone Number

Tarrytown, New York, Us

Centennial, Colorado, Us

With a background in project management, product testing, and process validations for biological products, I oversee client product onboarding and testing suitability. In 2023, I was honored with the Testing for Life award for my exceptional role as a Method Validation Supervisor, recognized by senior executives for dedication, expertise, and leadership in ensuring critical method validation. Key achievements include:- Establishing a robust Methods and Validations Department, designing processes, implementing procedures, developing project management systems, and recruiting and training staff to meet industry best practices and regulatory standards.- Managing the department to surpass revenue targets through resource optimization, process enhancement, and successful project execution, enhancing profitability and client satisfaction.- Leading successful onboarding and validation of microbiological methods for 72 client products in 2022 and 79 in 2023, ensuring timely completion, accuracy, and compliance for expanded service offerings.- Setting sterilization and verification doses for biologic and HCT/P products via bioburden analysis and sterility testing,; quarterly analysis of results for continuous improvement and regulatory compliance.- Ensuring regulatory compliance for routine microbial testing per USP and ISO guidelines, emphasizing quality standards adherence.- Providing microbial expertise in product method development for testing efficiency and innovation.- Conducting method suitability testing on client products using advanced techniques like membrane filtration and direct inoculation for accurate and reliable testing.In my role, I leverage leadership, strategic planning, and project management skills to drive successful outcomes, foster collaboration, and deliver impactful solutions for clients. My commitment to excellence, continuous improvement, regulatory compliance, and innovation in biological product testing is integral to my approach.

Wilmington, Massachusetts, Us

As a Remote Microbiology Specialist, I took the lead in developing and implementing the Contamination Control Strategy for Cell and Gene Therapies and Cross-contamination in a Multi-Product Manufacturing Facility. My role involved:- Managing the Environmental Monitoring (EM) Program, Sterility test, Growth Promotion, Endotoxin testing, Mycoplasma testing, and the Gowning Qualification Program through virtual collaboration and remote oversight.-Conducting Environmental Monitoring Performance Qualifications, implementing protocols to monitor and study microbes, tracking environmental microorganism development, and review and trending of the environmental conditions for 20+ cleanrooms to maintain a controlled manufacturing and laboratory environment.- Serving as the aseptic processing subject matter expert (SME) for Aseptic Operator Qualifications, Process Simulations, and Smoke Studies, providing remote guidance and support.-Authoring, initiating, and preparing process validations and testing validations remotely for the CDMO Microbiology testing laboratory to ensure regulatory compliance and scientific validity of experiments.- Collaborating with laboratories and external clients virtually to address method/protocol development, contamination events, and compliance issues for the multi-product facility.- Mentoring team members in GMP practices and supporting investigations, CAPAs, and data analysis through remote communication and virtual platforms.- Acting as the remote point of contact for vendors, consultants, clients, and auditors, providing technical expertise on microbiological assays and techniques through remote consultations.In my role as a Remote Microbiology Specialist, I successfully navigated virtual collaborations, remote client-driven safety testing consultation, and digital platforms to drive operational excellence, maintain high-quality standards, and ensure regulatory compliance in microbiology, contamination control, and team leadership.

Memphis, Tn, Us

As the Supervisor of Quality Control Microbiology at a leading Contract Development and Manufacturing Organization (CDMO), I played a pivotal role in overseeing the day-to-day operations of the Microbiology Laboratory and ensuring adherence to company policies and Good Laboratory Practices (GLP). My responsibilities included:- Supervising laboratory activities to guarantee the testing of all products in alignment with company standards and regulatory requirements, specifically focusing on the microbiological aspects of cellular and gene therapies produced at the facility.- Leading a team of skilled microbiologists proficient in a broad range of analytical and scientific techniques for microbial monitoring and testing, including rapid microbiological methods such as BacT/ALERT 3D Dual-T and qPCR mycoplasma.- Providing technical expertise in the development and execution of studies, protocols, and reports in alignment with EU and FDA guidelines for Investigational New Drug (IND) and Biologics License Application (BLA) filings.- Monitoring and trending environmental microorganism recoveries and facility excursion rates, while actively contributing to the development of policies, risk assessments, standard operating procedures (SOPs), Corrective and Preventive Actions (CAPAs), and non-conformances (NCs).In addition to my supervisory role, I led a high-performing lab team in achieving company and client objectives by overseeing safety testing of client products, conducting investigations for microbiology excursions and non-conformances, and facilitating the implementation and enhancement of visual inspection processes for Parenteral Products. My expertise in cGMP regulations and guidance documents enabled me to author, perform, and approve test methods and procedures for the QC Microbiology department, while providing guidance and mentorship to analysts for their technical and personal development.

Memphis, Tn, Us

As a Quality Control Microbiology Lead, I excelled in authoring, revising, and reviewing test methods and SOPs to ensure strict adherence to regulatory requirements while engaging with stakeholders, departments, and clients. Additionally, I performed the following marketable tasks at a CDMO:- Developed and executed qualification documents and reports for Inhibition and Enhancement screenings, Bacteriostasis and Fungistasis evaluation, and method suitability assessments on new incoming, in-process, and final client products, demonstrating expertise in quality control testing methodologies.- Implemented an Acceptable Quality Limit (AQL) sampling procedure into QC Inspection processes for Phase 3 drug products, enhancing quality assurance measures and product acceptance criteria.- Spearheaded the design and execution of an onboarding and training program for new 2020 recruits in the QCM lab, streamlining training processes, improving assessments, and ensuring compliance with industry standards.- Led training initiatives for department trainers and developed comprehensive training requirements to enhance the skillset of new employees, showcasing leadership and mentorship capabilities in talent development.- Collaborated cross-functionally with various departments and clients to identify and address root causes of environmental excursions, fostering a culture of continuous improvement and proactive problem-solving in contamination control strategies.- Acted as a key liaison for coordinating with stakeholders across departments and clients to uphold regulatory standards, drive compliance, and ensure the highest quality standards in microbiological testing practices.By highlighting these valuable experiences, I demonstrated my expertise in leadership in quality control microbiology, regulatory compliance, training and development, quality assurance improvement, and successful collaboration within a dynamic CDMO setting.

Memphis, Tn, Us

As a Quality Control Microbiology Analyst, I was recognized as the Employee of the Month for spearheading Visual Inspection Program Enhancements in December 2019 and achieving method validation of the BacT/ALERT 3D Microbial Detection System. Additional experiences include:- Conducting safety release testing procedures such as bacterial endotoxin testing, Mycoplasma Real-Time PCR, and rapid sterility testing, supporting client aseptic process simulations, and performing growth promotion studies on media.- Excelling in preliminary identification of bacteria and fungi using classic microbiological techniques, microscopic analysis through gram-stains, Schaeffer-Fulton stains, and particulate identification, and tracking and trending client particulates, environmental monitoring samples, and microorganisms.- Contributing to method development by creating innovative approaches for generating a stock of the facility's microflora.- Efficiently analyzing over 3000 defects within client samples for six clients in 2020, showcasing attention to detail and quality assurance expertise.- Qualifying 33 additional inspectors across two departments, resulting in an 800% increase in visual inspectors, demonstrating leadership and training capabilities.- Effectively scheduling and coordinating a 100% increase in visual inspections of cellular therapy products from 2019 to 2020, highlighting organizational skills in inspection processes.Through my skill set in microbiological testing, quality control methodologies, defect analysis, inspection coordination, and training initiatives, I have consistently maintained high standards of quality, compliance, and efficiency in a dynamic CDMO environment.

Memphis, Tn, Us

As an Environmental Monitoring Analyst with a proven track record, I specialized in conducting environmental monitoring (EM) of GMP aseptic operations and controlled areas at a leading CDMO. I meticulously collected non-viable particulate, air-viable particulate, and surface viable samples using advanced equipment, ensuring accuracy and adherence to stringent SOPs and Good Documentation Practices (GDPs) to obtain and record high-quality data. By interpreting results and analyzing EM trends, I played a crucial role in maintaining compliance with regulatory requirements such as USP guidelines and cGMP procedures.In addition, these core responsibilities as an Environmental Monitoring Analyst included: - Processing environmental monitoring samples with precision and attention to detail, generating accurate and reliable data for analysis, trend identification, and continuous improvement initiatives.- Authoring and participating in investigations, such as Non-conformances and Environmental Action Reports, to address deviations, implement corrective actions, and drive quality enhancements in environmental monitoring processes.Through my expertise in environmental monitoring, microbiological testing, regulatory compliance, and investigative procedures, I have consistently demonstrated a commitment to maintaining high-quality standards, ensuring regulatory adherence, and optimizing operational efficiency.

Memphis, Tn, Us

Collected and processed 4,000 host-plant associations for a Cerambycinae beetle’s databaseManaged a slide collection of 500+ weevilsCompleted training in University Laboratory Safety through EH&S