Michael Gallagher Email & Phone Number

Dublin, IE

San Rafael, CA, US

• Leadership role influencing key program teams and overall program strategy
• Supporting clinical development drug candidates from pre-clinical through to commercial launch and lifecycle management
• Manage teams to ensure appropriate budgeting, resourcing and reporting of program progress to executive management to ensure alignment with corporate strategy and achievement of corporate goals
• Managing cross-functional PM, development and commercial teams to facilitate the integration of key work streams which support the program through development stages and launch

San Rafael, CA, US

• Managing tech transfer/development projects as outlined in below Manager role. Reporting to Director of MSAT, I have responsibility for global commercial/clinical aseptic drug product fill finish activities for.

San Rafael, CA, US

• Leading drug product development, tech transfer, process improvement and COGs improvement projects at CMOs and internal sites for drug product manufacturing and secondary packaging of vials, dual-chamber cartridges and.
• Managing cross-functional global network strategy initiatives which involves completing financial analysis, collating operational and quality data to inform senior leaders on our external manufacturing business and.
• Technical SME for issues at CMOs and supporting assessments of new CMOs
• Authoring sections for NDAs, INDs, MAAs and managing post-approval CMC documentationall technical activities (technology transfers between CMOs and to internal drug product sites)
• CMC sub-team lead for drug product programs
• Responsible for early-stage clinical to commercialised biologics products

San Rafael, CA, US

• Managing DP tech transfers to external manufacturers and completing on-site CMO visits for DP production support
• Identifying and leading projects in process optimisation / development
• Carrying out functions detailed below in Snr. Associate / Associate roles

San Rafael, CA, US

• Supporting tech transfers, process improvements and project work being conducted in our CMO network for fill finish and secondary packaging
• Participating in regulatory, financial and customer audits in addition to supporting audit responses
• Carrying out functions detailed below in Associate role

San Rafael, CA, US

• Coordinating aseptic fill finish production of sterile products and monitoring production at contract manufacturing sites as a person-in-plant (PIP) for clinical and commercial products
• Assisting in the scheduling of all commercial batches, directing shipment of bulk and finished product at external manufacturing sites and managing the transfer of documentation
• Managing the supply of materials required for aseptic fill finish production, controlling stock levels and management of drug substance and drug product inventories at CMOs
• Liaising with Quality, Regulatory, CMC Teams, Supply Chain, Logistics and Validation departments on all CMO related activities
• Actively managing the contract manufacturer relationship including the delivery of projects
• Assisting technical transfer activities as required

Paris, France, FR

• Provided microbiological support to the site across various departments including sterile fill finish and oral dose manufacturing
• Performed tests critical to compliance for aseptic filling of biologics such as sterility testing, bioburden and endotoxin testing, environmental monitoring, personnel monitoring and utilities testing
• Gained valuable experience with Trackwise QMS software, LIMS and with regulatory agency inspections

Luxembourg, Luxembourg, LU

• Received client samples and reviewed documentation to establish which tests were required to be performed within the Eurofins network of laboratories
• Liaised with internal departments within Eurofins as well as with couriers to ensure that we met our clients’ needs in a most cost effective manner whilst maintaining a high quality of customer service
• Gained experience with eLIMS Laboratory Information Management System software

• Learned valuable skills in conducting market analysis, financial feasibility studies, technical feasibility studies and in analysing market trends
• Carried out an extensive feasibility analysis for a novel industrial biotechnology company and developed a comprehensive business plan for an attractive and feasible business opportunity

• Assisted the pharmacist in the preparation of medicines for customers
• Liaised with company representatives has benefited my communication skills as well as my understanding of the pharmaceutical industry

Waterford, IE

• Worked as part of the Empower team on the implementation of the new chromatography data software program ‘Empower 2’
• A key element to my work was to assist the company in preparation for internal / customer / regulatory agency inspections
• Ensured that all work carried out was in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations, safety and environmental guidelines

Toronto, Ontario, CA

• Responsible for the validation of coin, bill and card operated control systems

Master Of Business Administration - Mba

Managing Risk And System Change (Postgraduate Diploma)

Master Of Science (Msc), Biotechnology And Business

Bachelor Of Science (Bsc), Microbiology

Introduction To Lean Sigma Quality