Lauren Beach Email and Phone Number

Lead and manage a diverse and multidisciplinary team of six scientists and contractors at Rahway Building 119 Core development and GMP clinical production areas to shape drug delivery strategies. Collaborate effectively within and across functional areas, including engineering, facilities, safety and quality. Facilitate the development of formulations in support of Oral and Specialty Products. Execute Phase 2B/Phase 3 clinical trial supply production for drug device combination, including campaign planning and preparation. Production responsibilities include generation and review of batch records, sourcing and ordering of materials, ensuring facility and equipment readiness, training and assigning personnel, multiple process manufacturing, sampling and final release of product, investigations, change records and internal/external quality audits. Oversaw all aspects of facility readiness including equipment/facility cleaning, equipment, facility and process calibrations, raw materials availability, ensuring safety and environmental conditions to support development and GMP activities. Generate and review equipment and area commissioning, qualification, validation activities, and standard operating procedures (SOPs). As part of facilities readiness, work with multiple managed service providers to coordinate routine and emergent services as needed.

Pharmaceutical Operations Lead of Building 119. Building 119, part of the Merck FLEx Center, houses Drug Product Development and GMP clinical manufacturing at Merck's Rahway, New Jersey site. Building 119 provides a launch pad for the formulation development of Oral Solid and Specialty products and provides GMP supply capability to Specialty programs.

Scientific and technical leader responsible for pre-formulation, formulation, and process development aspects of pharmaceutical dosage form development projects using Aprecia’s 3DP technology, including registration, validation and commercialization.

My responsibilities include guiding lab and pilot scale formulation development of high drug loading, fast dispersing, orally disintegrating dosage forms made by 3-dimensional printing. This includes developing complex formulations specifically for the 3-dimensional printing process and overseeing and participating in experimentation and analysis to develop process parameters at lab, pilot and commercial scale. Other work includes developing a novel taste masking approach for bitter drug for use in the company’s novel dosage form. Responsible for scale up of taste masked particulate material from lab, to pilot and commercial batch sizes at international contract manufacturing organization. Additional responsibilities include authoring regulatory filings, writing standard operating procedures, conducting training on procedures, and writing technical reports related to protocols and project work.

Worked in the New Jersey Center for Engineered Particulates to develop batch and continuous methods to modify and functionalize cohesive pharmaceutical powders with nano particles. The aim was to reduce cohesive forces between particles and improve overall flow. Fully characterized powders both before and after functionalizion to quantitate the improvement. Published a total of 4 peer reviewed papers during PhD work.

Worked in the Materials Assessment Laboratory for Materials Science Oral Products Division investigating and characterizing flow improvement of pharmaceutical powders. Developed novel continuous operation device for surface modification of pharmaceutical drug powders. Two peer-reviewed journal articles published.

Worked with the Microfiltration group to develop new membrane technology for a virus filtration unit used in biopharmaceutical applications. Qualified and improved existing technology.