Bill Key Email & Phone Number

Spring, Tx, Us

Philadelphia, Pa, Us

• Member of the North American SMART Function for PCI Clinical Services coordinating all supply requirements between PCI and the customer. Responsibilities are established by the client but can cover any aspect of the clinical supply chain.o In partnership with or on behalf of PCI clients, act as single point of contact in coordinating the necessary information between clinical functions, ensuring that clinical supplies are available in appropriate quantities where and when they are needed to support clinical studies.o Client advocate for study set-up and maintenance from drug supply perspectiveo Work in an unblinded capacity with secure, confidential study informationo Participate in cross-functional teams to ensure clear communication and manage expectations relating to drug supplyo Drug supply demand forecasting and managemento Support comparator and ancillary product procurement strategyo Build drug projections, distribution strategy, and plan packaging campaigns o Work with vendors to set up and manage drug supply portion of IxRT o Depot setup and distribution strategyo Manage and monitor clinical supply inventory at depots and sites as neededo Drug supply budget management at program and/or study levelo Coordinate drug return, accountability and destruction

The Woodlands, Tx, Us

Locate, qualify, plan, negotiate and award purchase commitments based on supplier secondary packaging, labeling, distribution, returns, and ancillary supply sourcing capabilities. Monitor and influence supplier performance based on key measurement criteria. Participate on cross-functional teams to aid in balance of clinical supply forecasts vs. inventory levels, supplier deliveries, production schedules, and transportation channels for new product development. Assist Lexicon contracted suppliers with management and control of inventory Manage the trafficking of clinical trial materials and/or bulk drug products to and from Lexicon Contract Manufacturer(s)/Packagers. Support Clinical in the development, integration, and daily oversight (as specified by Clinical) of any trial specific IVRS or IWS systems or an in-house manual process when opted for.Maintain and liaise with Lexicon departments to develop and maintain their personal knowledge of all relevant import/export law and procedures; tariffs and duties; licenses and restrictions.Coordinate and interface with government agencies related to Customs activities, directly or via in country resources, in respect to commodity classifications, customs rulings, regulatory interpretations, regulatory changes, and free trade agreements.Manage customs broker, courier, and freight forwarder relations to ensure their processes comply with applicable regulations when acting on the company's behalf.Plan, develop, and implement U.S. Import & Export strategy and procedures consistent with overall aims and requirements of Lexicon. Elements include compliance manuals, plans, training materials, and self audit templates.

The Woodlands, Tx, Us

Responsible for all aspects of Clinical Supply Chain Management. Networking with CRO/CMO for forecasting CTM needs and primary/secondary packaging formats.

The Woodlands, Tx, Us

Process Development and Optimization in Upstream Scaleup and downstream purification of antibody targets and therapeutic proteins. Managed a Process Science team of high level associates for timely delivery and QC of proof of concept biologics in animal testing models.

Defining Novel Protein Function in Baculovirus, furthering the optimization of the BEVS system and developing possible biological pesticides.

Huntsville, Texas, Us

Mail Clerk for the Ellis I maximum security Prison. Home of Texas Death Row. Monitored criminal gang activity, contraband, and general incoming and outgoing mail. Included package searches and screens.

Managed a beef cattle operation for registered Brahman and Angus cattle. Included running pure bred F-1 herds. Equipment upkeep (heavy machineary). Custom hay bailing and range management. Pedigree research and upkeep. Managed and operated the ranches professional show cattle and lead the show team in 5 consecuative top ten finishes in Texas Club Calf Association. Including a 1990 World Championship and numerous Grand Championship finishes at all Major Stockshows. Won the 1990 World Champion Showmanship award for TCCA, ABBA, and placed in top 15 of the world for National Angus Association Showmanship Contest.

B.S., Microbiology

General Studies