August Wright Email & Phone Number

Washington D.C. Metro Area

Frederick Md

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Rockville, Maryland

ABL Inc. -Advanced Bioscience Laboratories, Rockville, MD Project Manager II- Innovation and TranslationWell established leader in providing quality contract manufacturing services for the production of vaccines, gene therapies, oncolytic, monoclonal antibodies and other therapeutic proteins.• Current- Government Project Manager for high priority, high visibility projects, with the National Institute of Allergy and Infectious Diseases (NIH) in the pursuit of a Global HIV Vaccine.• Direct access to the Division of Aids (DAIDS) Contracting Officer (CO) and Contracting Officer Representative (COR). On pace to increase ABL project revenue on current high target projects by 30% in the first year.• Responsible for all project management stages in the development cycle from vial thaw to IND filing including concept management, process development, small scale test studies, large scale engineering and cGMP production. • Task Order Proposal project management and business process development lead for new and inbound government projects in support of multimillion dollar master government contracts.• Responsible for internal and external subcontractor development programs to facilitate a seamless transition between internal and external partners via operational excellence initiatives such as Kaizen, 6S from concept to 1st stage manufacturing to support clinical trials.• Currently responsible for and managing 6 Government projects with a collective value of $32M.

Rockville, Maryland

IDT-Biologika Corporation, Rockville, MD Upstream Process Engineer and Manufacturing LeadInternational leader in biotechnology with a tradition of manufacturing vaccines and pharmaceuticals to improve the health of humans and animals. IDT is among the top echelon of innovative high-tech life science companies in the standardized production of bio-pharmaceuticals, focusing on contract manufacturing and animal health. • • Project Manager and Operations Lead for the Upstream Tech Transfer, tactical and planning teams.• Responsible for process development of adherent and suspension cell culture based systems. Training architect and business process development lead for all incoming CMO projects• Transitioned project management platforms via change management strategies to include accurate representation of full site capabilities in cGMP and non-GMP project scopes.• Managed various internal, CMO client and tech transfer projects.• Successfully redesigned inter-departmental communications and business process management systems.• Responsible for budget review, internal and external process overview presentations, and time-line tracking.• Implemented new manufacturing practices, utilizing Lean-Six Sigma Processes, for tech-transfer into the cGMP suite plant. • Provided process awareness and training to upstream manufacturing, QC, and QA teams for the manufacturing of new products and implementation of new technologies.• Responsible for Batch Record design, review and end-to-end product campaign management

Frederick, Maryland

ASTRAZENECA/ MEDIMMUNE LLC, Frederick, MD Upstream Process Engineer (Subject Matter Expert (SME))One of the leading biopharmaceutical firms in world with $85B market cap, and one of the world’s leading vaccine supplier.•Served as an Upstream Subject Matter Expert for the AstraZeneca’s tactical and planning teams.•SME in the process development of adherent cell culture based systems and aseptic transfer systems. Trained, led and motivated Upstream Cell cultivation, Downstream Purification, and Support teams in the manufacturing and preparation of Media and other required solutions. Followed cGMP principles in designing new Single Use Systems and aseptic product transfer processes for existing manufacturing systems. Analyzed, developed, implemented, and drove continuous improvements for manufacturing processes. •Designed AstraZeneca/Medimmune, Merck tech transfer processes from small scale operations to phase 3 global supply chains.•Transitioned process platforms to improve output and manipulation risk in cGMP and Non-GMP space and development labs.• Managed various internal and CMO scale transfer projects and successfully transferred 6 global 3rd stage products from small scale R&D stages to large scale manufacturing operations, working with key stakeholders; resulting in the release of two commercial products. Generated and reviewed manufacturing documents and assisted in validation studies.•Designed AstraZeneca’s Global Single-Use Strategy, advised and provided path forward for manufacturing process efficiencies for aseptic transfer and closed systems product capture.•Identified and assessed safe manufacturing practices for tech-transfer into the cGMP suite through the use of Lean-Six Sigma Processes.