Alison Saunders Email & Phone Number

Chapel Hill, Nc, Us

Chapel Hill, Nc, Us

Indianapolis, Indiana, Us

Basel, Baselstadt, Ch

Basel, Baselstadt, Ch

•Responsible for the overall quality and disposition of materials (including media, buffers, cell expansion, upstream and drug substance) manufactured in-house and batch review.•Collaborate with manufacturing and manufacturing quality teams to ensure adherence to batch records, clinical protocols and regulatory requirements for manufactured gene therapies.•Facilitate weekly disposition meetings with a cross-functional team to ensure a state of control and drive action where appropriate•Contribute and report to the key site metric for quality and compliance, report to management all necessary information regarding product release • Provide SME support for Quality Systems including Deviations, CAPAs and Change Controls• Perform production Lot Number assignment• Issuance and reconciliation of batch records, sampling labels and controlled forms• Ensure area documentation remains in compliance with cGDP• Author, revise, and review SOPs, Work Instructions, and OJT Documents

New York, New York, Us

• Own, track, and support quality records (Root cause investigations from minor to complex scope, corrective and preventive action (CAPA) ownership, change controls, and audit responses/commitments). Provide guidance and support to manufacturing personnel with root cause investigations when needed.• Create and revise GMP documentation. Review GMP documentation for areas of improvement, applicable references, and alignment with local and global procedures.• Own equipment and/or systems that support the manufacture of clinical drug supplies including creation and maintenance of appropriate systems and their documentation.• Work in electronic systems including QMS (i.e. Trackwise), Documentation, LIMS, (i.e. SAP/Axis 360), Process Automation systems (i.e. Delta V, Finesse), etc. This includes understanding of data integrity principles and application within systems.

Perform cell separation, maturation, and transfection of PBMC derived Dendritic Cells to produce autologous Cancer Immunotherapy for Phase III Clinical Trial (350+ subjects).Responsible for training 10+ associates in preparation for a pivotal Phase III trial. Serve as a qualified trainer for annual process and personnel media simulations, gowning qualifications and EM. Developed a new training plan that reduced the amount of time required to train new employees.Played a vital role in transitioning from a paper batch record system to an electronic batch record system (EBRS) through IQ/OQ/PQ tech transfer and installation of FactoryTalk PharmaSuite (FTPS). Responsible for EBRS recipe authoring, order creation, and addressing EBRS exceptions.Successfully executed Argos’s first Aseptic Process Validation (APV) processing run through aseptic technique and adherence to proper gowning procedures to ensure product integrity and personnel safety. Organized cross functional team collaborations to generate new procedures for process validation execution, media inspections, and qualifying inspectors.Initiate and respond to Quality Systems documents including DRs, CRs and CAPAs to determine root cause analysis ensuring critical processing timelines are met. Involves working closely with various support groups; QA, QC, Facilities and Materials Management. Conducted training for external international partners, which included: gowning training and gowning qualifications, demonstrating the Cell MFG process flow using required aseptic techniques within the cleanrooms, and demonstrating manipulations required for tech transfer.Assist with preparation activities to transition to a new facility. Worked to estimate the cost of goods (COGs) for Cell MFG activities, developed a spreadsheet for personnel headcount requirements, and created MFG timelines for hiring personnel. Collaborated on processing room layouts, material flow, and new equipment requirements.

Perform cell separation, maturation, and transfection of PBMC derived Dendritic Cells to produce autologous Cancer Immunotherapy for Phase III Clinical Trial (350+ subjects).Execute procedures to manufacture autologous immunotherapy product (including Phase II clinical trials for RCC and HIV) ensuring that production batch records (paper or electronic) were completed at the highest standards. Processing involved isolating, culturing, maturing and harvesting Dendritic Cells from patient Leukapheresis samples for patient specific therapy.Assist in coordinating and scheduling environmental monitoring (EM) activities. Execute and document EM of air, surfaces, and personnel in classified areas as required using MODA-EM.Performed IQ and OQ Validation Protocols for processing equipment.Responsible for performing routine and preventative maintenance on laboratory and processing equipment.Perform procedures and calculations crucial to quality controls, including elutriation, electroporation, centrifugation and large and small volume pipetting.Author, review and revise batch records, electronic recipes, SOPs, and item specifications required for the manufacture of product.Review and organize completed batch records, address deviations, and support investigations as necessary ensuring that all processes and procedures performed are accurately documented in a timely manner in accordance with company and FDA regulations.

Perform cell separation, maturation, and transfection of PBMC derived Dendritic Cells to produce autologous Cancer Immunotherapy.Execute procedures to manufacture autologous immunotherapy product (including Phase II clinical trials for RCC and HIV) ensuring that production batch records (paper or electronic) were completed at the highest standards. Processing involved isolating, culturing, maturing and harvesting Dendritic Cells from patient Leukapheresis samples for patient specific therapy.Worked closely with Process Development to develop and implement process changes and cross trained on RNA MFG processes to assist molecular biology manufacturing group with processing as required.Perform daily clean room activities (equipment/material preparation and cleaning/sanitization of equipment and rooms) while ensuring adherence to company and governmental GMP regulations, policies and procedures.

Maintained and harvested cultures of multiple cell lines, collected, tested, analyzed and labeled samples. Performed cell viability and proliferation assays on cell lines as a screen to test the activity of multiple proprietary oncology compounds.Created and maintained spreadsheets for recording results of cellular assays.Responsible for daily laboratory maintenance and upkeep.

Raleigh, North Carolina, Us

Assisted graduate student to conduct experiments to evaluate the temperature effects and extension cooling rates on boar semen quality.Effectively used Spermvision®, a computer assisted program to provide an in-depth analysis of boar sperm for motility rates for research applications.Extended boar semen in preparation of performing various tests.Prepared gelatin slides.Cleaned and autoclaved glassware.

Bachelor Of Science - Bs, Animal Sciences

Bs, Animal Science