Gary Morris Email & Phone Number

County Dublin, Ireland

County Dublin, Ireland

Technical leader of the engineering function. Devised and drove the strategy for change in the technical governance of research and development programs within APC’s small molecule portfolio to support preservation of technical excellence as the organization scales. In partnership with the Chemistry Technical Lead, jointly responsible for the technical robustness of all small molecule research and development programs. Empowered within this framework to provide senior level oversight, direction, and technical and leadership coaching to an interdisciplinary team of project technical leads (PTLs) who lead our small molecule research programs in partnership with project managers. Key responsibilities are to:• Develop and drive the portfolio-wide deployment of advanced process development strategies and best practice workflows that are founded on chemical engineering design principles.• Mentor senior engineers and scientists in the skills and proficiencies required for the PTL role.• Actively review the engineering activities of all small molecule research and development programs, benchmarking technical depth, progress, and throughput, and ensuring the alignment of research direction and scientific outcomes with the development objectives of the project.• Spearhead the development and commercialization of new process development methodologies and technologies to grow new areas of technical focus and broaden service offerings.• Serve as a senior point of escalation (internal and external) for any directional/technical issues arising on research and development programs.

County Dublin, Ireland

Directed and managed a technology and process development team of seven, with expertise in engineering, chemistry, and analytical disciplines (BE/BSc to PhD) and broad professional experience (newly graduated to 10+ years in industry). Provided technical mentorship, guidance, critical feedback and appraisal, and annual objective setting and review for career development and growth of team members. Exerted technical leadership and project management in the coordination and delivery of 15 process development collaborations, varying in length (2 – 18 months) and resource size (1 – 6 FTEs). Collaborated with external partners on a diverse range of drug substance process development activities, including early stage process design and development; optimization, robustness improvement, and scale-up; process characterization (CPP definition and PAR testing); data generation for regulatory submissions; process troubleshooting; processing technology design; and continuous process development. Drove the expansion of APC’s business in continuous processing and alternative manufacturing technologies by building out additional platform capability, growing our SME base, winning research contracts, and leading the completion of commercial projects in this area. Selected R&D highlights:• Delivered an accelerated QbD program for the generation of rigorous data to support an NDA submission.• Led the development of a novel pressurized extraction and semi-batch crystallization process, from concept design to provision of a model-supported scale-up strategy implemented at pilot-scale (1,450 L).• Supported NPI of a cGMP continuous drug substance process to a manufacturing site for production of 7 – 10 kg/day of API.• Coordinated a program to develop the control system for the acylation of a peptide in flow.• Led the development of a continuous API crystallization leveraging 2D PBE modelling to steer process optimization to deliver a superior crystal aspect ratio versus batch.

County Dublin, Ireland

Expanded sphere of influence. Concurrently supported a variety of modelling and technology application tasks across multiple crystallization development programs and coached junior and senior technical staff in advanced particle engineering concepts, while also leading laboratory process R&D efforts on a day-to-day basis as a primary responsibility. Proactively engaged with project scoping and proposal writing to upgrade APC’s standard crystallization development package to include advanced particle engineering concepts. Authored process design guides for continuous crystallization to accelerate wider team understanding and increase the deployment of the technology into development programs. These guides included a workflow for screening crystallization systems to evaluate suitability for transitioning from batch to a continuous processing mode, methodologies for acquiring crystallization kinetics and how to use population balance models in crystallization development, SOPs and build guides for MSMPR and tubular crystallizer platforms, and application notes for novel platform uses of continuous crystallizers during batch crystallization process development, e.g., in seed material design and characterization of polymorph/pseudopolymorph kinetics. Led several laboratory process R&D efforts focused on the design and optimization of both batch and continuous multistep drug substance processes to deliver desired API physiochemical properties. Developed the first multistep continuous drug substance process researched at APC, which included integrated CSTR, workup, MSMPR crystallizer, and automated semi-continuous filtration and washing unit operations. Applied reaction and crystallization process modelling expertise to design individual unit operations and drive optimization of the integrated continuous process to deliver API particle size requirements directly, eliminating a milling step that was required in the original batch process.

County Dublin, Ireland

Led laboratory process R&D efforts on a number of batch and continuous crystallization development programs focused on optimizing API physical properties to satisfy formulation and bioavailability requirements. Devised optimum operating policies to deliver particle size and crystal form targets in required purity and yield. Performed laboratory scale-down/scale-up investigations in conjunction with process modelling to ensure that optimum operating policies were scalable and robust for implementation in manufacturing. Transferred these processes to client manufacturing sites and CMOs.Spearheaded the development of batch and continuous crystallization population balance models for company-wide application on crystallization development projects. Authored technical reports and led technical communications with external pharmaceutical partners and CMOs. Provided internal training to peers and senior technical staff on the application of PAT in crystallization development, continuous crystallization, and model-supported crystallization process design.

County Dublin, Ireland

Joined APC in a part-time capacity to accelerate the organization’s movement into continuous processing. Led the design and build-out of APC’s continuous MSMPR crystallizer platforms, and supported technical staff by providing training and experimental support on the deployment of the technology into commercial research and development programs.

Kinsale, County Cork, Ireland

Carrigaline, County Cork, Ireland

Phd In Chemical Engineering

Thesis: Design and Optimization of Continuous Crystallization Systems for Application in Pharmaceutical Manufacture. Funding: Irish.

Be In Chemical Engineering, 1H – First Class Honours

Accredited at a Master of Engineering level by the IChemE.