Leslie O'Donnell Email & Phone Number

Dresher, Pa, Us

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, Us

Philadelphia, Pennsylvania, Us

Specializing in Tech Transfer

Lancaster, Pa, Us

Cell Banking – Produce Developmental, Master and Working Mammalian Cell Banks to support products in pre-clinical development, phase I, phase II, and phase III clinical trials. Produce Master and Working Cell banks for commercial products. • Trained support staff and contractors in Cell Banking specific procedures• Revised procedures for In-Process Environmental Monitoring that led to a decrease in Out-Of-Specification In-Process Environmental Monitoring results• Developed a Cell Banking specific procedure for aseptic qualification• Wrote the Cell Banking portion for a Phase II IND for a New Microbial Product• Initiated guidelines for testing of Microbial Cell Banks • Review Cell Bank History reports for Mammalian Working Cell Banks• Initiate and review Safety Assessments for in-licensed Mammalian and Microbial Cell Banks

Newark, De, Us

May2015 - JAN2016 - Quality Control – Perform testing on in process and final material for lot release from ascites and mammalian expression systems. Types of testing include but are not limited to: Radial Immunodiffusion (RID), ELISA, Isoelectric focusing (IEF), HPLC, Isotype and Bioburden.JAN2015 - May2015 - Downstream Processing - Purified proteins from ascites and mammalian expression systems to fill external customer orders as well as working with internal customers to assist with possible pre-clinical products.MAR2012 - JAN2015 - Genomic Antibody Technology - The sole employee responsible for producing genetic immunization and protein boosting material used in the production of polyclonal antibodies.

2010Purified Proteins from mammalian expression systems for clinical trials, toxicology studies and reference standards. Eliminated the use of expired raw materials by implementing a "first-in-first-out" (FIFO) system to thereby avoiding non-conformances due to the use of the expired materials. Piloted use of the Chromaflow packing system in packing 60 cm columns.Saved the company tens of millions of dollars by responding to equipment and facility alarms as part of the call out team.

Us

Ran, harvested, analyzed and purified proteins from microbial fermentations at both large and small scale. Immobilized the microbial product to make 5 ETI (Erythrina Trypsin Inhibitor) columns, a critical purification component in the manufacture of Retavase. Built the Microbial Pilot Plant from an unused maintenance garage to a fully validated and highly efficient pilot plant. This was the first pilot plant in the company that controlled all phases of the production process including making media, microbial fermentation, protein purification, and coupling the purified protein to the resin. Increased production from a low of 0.09 g/L to greater than 2.5 g/L by developing a new method for a glucose feed. Wrote all the standard operating procedures and Master Batch Records covering use of the large scale fermentor, support equipment and the chromatography system.Contributed to validation activities including: sterilization of SIP tanks, sterilization of the microbial fermentor and its addition ports, all parts of the chromatography system, the WFI system, the USP water system and the Clean Steam system.Streamlined training by developing training modules for all Microbial Pilot Plant employees for use with online training system.Managed raw materials to ensure there was no interruption of production.Used SAP to complete raw materials transactions and track raw materials used in cGMP campaigns.

Brentford, Middlesex, Gb

Ran and harvested microbial fermentations at large and small scale to produce clinical supplies for Phase I clinical trials.Part of the first team to use a continuous flow centrifuge to harvest microbial fermentations leading to the largest microbial fermentation harvest for the company at that time. Several years of experience in academic research institutions, including The Wistar Institute and Thomas Jefferson University.

Philadelphia, Pennsylvania, Us

Philadelphia, Pa, Us

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Graduate Certificate, Supply Chain Management

Education record

Education record

Education record

Bs, Biology