Lorraine Scott Email & Phone Number

Lansdale, Pa And West Point, Pa

Manage execution of CMC documentation, including updates to Drug Master Files (DMFs), post-approval supplements related to manufacturing changes, and responses to health authority questions per established business processes and systems. • Identify, communicate and escalate potential regulatory issues to CMC management.• Ensure timely delivery of project milestones.• Interact with markets, iCMC and manufacturing sites to identify the requirements for the successful completion of projects.• Provide critical reviews of detailed CMC documentation.

West Point, Pa

Under direction from a Director and Associate Director, implemented CMC regulatory strategies for regulatory supplements in accordance with domestic and international regulations and guidance; responsible for preparation and submission of CMC sections for commercial pharmaceutical products.• Coordinated responsibilities related to successful project completion, including execution of regulatory strategy, use of business systems and project management.• Authored submissions for worldwide post approval pharmaceutical filings.

Spring House, Pa

Provided characterization and analytical analyses in support of regulatory submissions and product development across all areas of J&J: pharmaceutical, consumer and medical device.-Collected, interpreted and documented data to support product OOS and non-conformance investigations.-Trained new personnel and student interns on the use of laboratory equipment and procedures.-Wrote protocol and executed dissolution experiment to evaluate the influence of water on the morphology and drug release profile of hormone patches.-Prepared and submitted change control request/documentation to facilitate the move of laboratory assets to new facility. -Authored 18 study reports, plus a design summary describing the characterization activities related to the development & optimization of the hydrophilic coating process for a stent-graft device.-Validated test methods and characterized particulates generated during acute fatigue testing of SMART Nitinol stents using light obscuration and FTIR.-Conducted physical and chemical analysis of foreign material found in liquid formulation batches as part of a non-comformance investigation.

Spring House, Pa

Characterized the in vitro degradation of the polymeric formulation in drug-eluting stents over time, under a variety of conditions using gel permeation chromatography, microscopy and light obscuration in support of regulatory filings.-Wrote and executed study protocols.-Completed test method validation to ensure data quality and integrity.-Performed particulate analysis of the hydrophilic coating on stents to determine coating durability using micro-flow digital imaging.-Conducted a biocide media stability study to determine the effective levels of biocides and the degradation products generated during chronic fatigue testing.-Documentated data in laboratory notebooks and reported results in monthly status reports and project summaries.-Reviewed laboratory notebooks and assisted in preparing the laboratory for a regulatory audit.

Raritan, Nj/Spring House, Pa

Developed new and/or improved commercially viable processes to advance medicinal candidates through preclinical and clinical development while minimizing time to product launch.-Eliminated costly reagents and improved the efficiency of a final coupling step of a pyrazole intermediate, leading to a 30% reduction in the cost to prepare drug substance. Interfaced with contract lab to supply starting material for GMP campaign. Prepared project summary.-Contributed to an improved process for the synthesis of a glycoside derivative by preparing key intermediates and developing a purification/crystallization procedure for final product, which streamlined the previous process. Wrote chemistry section for the process patent and prepared technical reports to facilitate transfer of synthetic route to multi-kilogram and manufacturing scale.

Spring House, Pa

Designed safe, robust and selective processes for a broad range of compounds in all phases of drug development.-Developed a resolution/racemization procedure for a key intermediate. Described procedure in an article entitled “Crystallization-induced Asymmetric Transformation of p-Chlorophenylalanine Methyl Ester”, published in Tetrahedron: Asymmetry, 1998, 9, 3247.-Wrote and submitted the manuscript “1,1,2,3,3-Pentaisopropylguanidine” to Encyclopedia of Reagents for Organic Synthesis. Paquette, L.A., Ed.; John Wiley & Sons, New York, 1995.-Contributed to the development of a large-scale liquid phase peptide synthesis; performed critical couplings with minimal protection. Team received the Johnson & Johnson Award for “Development of Azaline B”.-Participated in the synthesis of KL4, a 21 amino acid protein; prepared gram quantities of the end fragment, intermediates and diastereomer in support of analytical development.-Played a key role in the development of a second-generation synthesis of a sulfamate derivative, resulting in a 50% reduction in the cost to prepare drug substance. Prepared two separate reports on the new and old processes and transferred methodology for scale-up. Organized and presented a complete overview of the project at the Annual Chemical Process Development Meeting. Co-authored process patent. Received the J&J Achievement Award for “Development of Topiramate Process” and the Optimus Award, a peer nominated/committee selected company award, for significant achievement in the development of the process.-Encountered a novel Carroll rearrangement involving acetoacetoxy p-quinols; exploration of rearrangement led to a complementary method for the preparation of phenylacetones. Co-authored and presented “The Carroll Rearrangement: A Facile Entry into Phenylacetone Derivatives” at local and national meetings.-Actively participated on Laboratory Safety Committee and conducted laboratory safety inspections.

Spring House, Pa

Participated in teams responsible for the rapid process development and scale-up of Active Pharmaceutical Ingredients (API) from bench to commercial scale.-Prepared, purified and submitted material for tox and FIH studies in a timely fashion.-Identified and isolated a unique process impurity that was used to determine infringement of a process patent, thereby preserving the company’s market share. Received the J&J Achievement Award for work.-Summarized and communicated process development results in written reports to the kilo-lab, pilot plant and manufacturing site in support of scale-up activities.

Ms, Chemistry

Ba, Chemistry