Thomas "Thom" G O'Sullivan Email and Phone Number

Drug Product Technologies leader

SME supporting IPS clients, colleagues, and project teams in biotechnology and bio-pharma aseptic process and drug product technologies. Engaged in project work including facility design, instruction and outfitting. Technical lead on drug product technology from concept to design through fabrication and vendor testing, into CQV including partner end user implementation. Support IPS plant design, construction and commissioning efforts. Advance IPS regional (New England) goals by supporting the IPS commitment to innovation in the development of global strategies and technology selections. SME on small, modular, isolated drug product formulation, filling and finishing technologies. Provides vendor, client representative insight and support while actively engaging in technical partner collaboration. Participates in facilities Concept Development, Basic of Design, and Detailed Design supporting client and aligning with discipline engineering, process architecture, process engineering and Qualification Testing to deliver value for the client to help drive work while meeting schedule, cost and delivery commitments.

Technical leadership in global support of Amgen Drug Product Technology and Operations in Ireland, Netherlands, in US in CA, and in Puerto Rico as well as CMO support as requested in EU and US and small market support in Brazil and Turkey to subsidiaries. Lead development of new class of isolated compact (Vanrx and VarioSys) fillers, midsize (HMLV) nested container fillers, and larger high speed bulk vial and nested syringe fillers (LMHV)utilizing ready to use and single use technologies in modular equipment and facility designs. Advance the Amgen pipeline by designing scalable technologies that help reduce complexity in technical transfers. Remote management of team in US and EU and collaborate cross site, cross functionally to drive value added changes into FF Ops. Support facility designs in US, EU, Japan (CMO), and plan new modular facilities for emerging markets. Completed project in 2019 that conceptualized, fabricated, designed, commissioned and qualified of new family of isolated adaptive fillers and high mix low volume isolated filling line systems using SUS and RTU components suitable for use in both stick built and modular GMP facility designs. Develop options for legacy DPs including container change into BFS and FFS and modality change options like Lyophilization and Spray Drying as change agents to reduce unit costs.

Global technical support for Drug Product Process Development focusing on equipment, processes and products in collaborative, cross functional and cross site teams.

Drug Product Technologies focused leader with global manufacturing science and technology support role. Enjoys connecting products and processes to equipment and separating out preferences from needs/wants in requirement development. I am capable of contributing in an individual role, or as a technical leader by developing high performing teams that extenuate collaboration, communication, first principles and a compliance driven, but risk based approach to problem solving. Prefers to lead from the front and is an advocate of cross site and cross functional relationships built on shared work at operations sites. Has developed and utilizes a strong network of peers, technical partners among equipment suppliers and critical process supply vendors, external C&Q contractors, and among a smaller but strong group of AE and Engineering firms to support project goals in global fill finish operations support work.

Transition Bulk Manufacturing of formulated DPs from Pfizer (WL) to King Pharmaceutical - support CMO at the Parkedale plant in Rochester, Michigan

Support CMO at Parkedale in Tech Svcs, supported Clinical Manufacturing for CMO and NPIs, Consent Decree mitigation planning/technical transfers for WL, business continuity support for Ampoule and Ointment filling, Bulk Manufacturing, Drug and Chemical Dispensing, Vaccine Mfg., and Component Prep

Supervisor for operations in developing drugs and reagent test kits for Cholesterol measurement, Tableting was supervised at a CMO, but final product formulation, media and buffer prep, aseptic filling, device assembly, label and packaging were all done in-house. Commissioning and qualification of critical clean utility systems and controlled room spaces, fill equipment design, fabrication, validation and characterization.

Diagnostic manufacturing - preparation of micro-plate readers and serial dilution plate systems for rapid microbiological identification of gram positive, gram negative and aerobic bacteria and viruses. Site formulated growth medias, solutions and performed serial dilution and filling of 96 and 150 hole plate systems which were then visually inspected, labeled, packaged then after QC sampling, were either freeze dried or flash frozen until final disposition.

Trained other supervisors, site and store managers and their staff in NJ Sanitarian codes. Sampled and tested products, excipients, ingredients for food products. Equipment cleaning, maintenance, and sanitization. Became a restaurant manager to augment my education and training with real experience applying rules in a fast paced work setting, covered shifts including nights, overnights and weekends.