Team
Our team has experience in the delivery of significant capital projects, leading global technology transfer programs, and the delivery of operational readiness and facility start-up leadership. We have experience of working both client-side and from within established consultancies.
Life Science Leadership
Cormac Callaghan
Cormac has been a senior executive with such firms as Amgen, Bristol Myers Squibb, and Merck. He is a leading program and project management professional who has carried out significant assignments as a consultant for major pharmaceutical, biologics and advanced therapies medicinal (ATMP) products investments. Cormac listens carefully to the needs of the client and in a calm manner formulates and frames agreed action plans to deliver on the business objectives. He provides insights in a measured but candid manner.
Barry Freyne
Barry has significant project and program management experience working on both consultancy and client-side roles in the design, construction, qualification, start-up and regulatory approval of new facilities. Barry has an in-depth knowledge of client business needs and is experienced in end-to-end project and program delivery from early concept phases through to tech transfer, operational readiness, regulatory approval, and plant start- up activities. Barry has strong technical ability with regards to biologics and oral solid dose.
Jose Sevilla
He has a demonstrated track record of efficiently managing tech transfers of DS and DP products to sites in the US, Europe, and Asia. He possesses a thorough knowledge of Biotech Process, capital project management, Good Manufacturing Practices (GMP), regulatory compliance, contract negotiations, planning, and manufacturing cost accounting.
Anna Lindeberg
of contract manufacturers associated with major tech transfer programs. Nicky has strong technical engineering experience and is a highly capable Chemical Engineer.
Anna has a reputation for successfully leading technical teams to deliver on business objectives and for identifying strategic opportunities in partnership with stakeholders. She motivates team members with a vision and clear goals, in a collaborative approach that emphasizes planned execution, accountability and empowerment. Demonstrated core technical expertise and a risk-based approach in engineering and science aspects of Biologic drug substances. Expertise in Technology transfer of 15 products from pre-clinical to commercial; new product introduction program management; process optimization; process validation; technical input to BLA & MAA; presentations during FDA and EMA (HPRA) site inspections; process engineering design and start-up of several drug substance facilities and pre-clinical to clinical operations management.
Nicky Phelan
Nicky has held project/program management and design management positions with both client organisations and consulting service providers. Nicky has held a variety of project management consulting roles for consultancies and pharmaceutical manufacturing companies in all stages of the project and program lifecycles. Nicky has significant experience in the delivery of complex capital projects and technology transfer programs across DP/DS biologics facilities and projects. Nicky has strong experience of management of contract manufacturers associated with major tech transfer programs. Nicky has strong technical engineering experience and is a highly capable Chemical Engineer.
Nicky has held project/program management and design management positions with both client organisations and consulting service providers. Nicky has held a variety of project management consu
Dervilia Grime
Specific expertise in technical transfer, process development and optimization, systems validation, and operational excellence. Knowledge and understanding of regulatory requirements including FDA, HPRA, KFDA, ANMAT and ANVISA. Dervilia has an ability to assimilate strategic priorities and translate into robust program and project execution plans, having worked on several small and large scale start-up facility projects which provided innovative solutions in facility design and operational excellence to deliver to global regulatory standards. A certified trainer and lecturer in pharmaceutical manufacturing, quality risk management and systems validation at diploma and degree level.
Amy Clarke
Amy has held leadership roles for contract QC laboratories and large biopharma client companies. She is a highly motivated individual with an excellent educational background and varied work experience. Amy thrives in working in a professional environment and has proven abilities in the areas of problem-solving, multi-tasking, analysis, communication, and leadership.
Gordon Saville
Gordon has proven analytical and troubleshooting skills with a demonstrated ability to work in self-managed, high performing teams and the ability to interact with all levels in the organisation and who has significantly contributed to teams and Quality processes within organisations. Gordon has extensive experience in all areas of Quality Operations in Pharmaceutical manufacturing and projects. Gordon’s previous roles include Quality Assurance Team Lead, Manufacturing Process Specialist, QA Specialist, QC Supervisor, and QC Analyst.
