GMACPHARMA Ltd. is led by Gary McAuslan, Founder, Managing Director and Principal Consultant with the company for over 4 years. Gary has almost 30 years’ pharma biotech experience, a dynamic, agile and energetic hands on leader, with expertise in developing in-house and 3rd party CDMO drug product development and commercialisation manufacturing capability. Gary has held many senior leadership posts in Pharma Biotech and advises academia, also as Adjunct Professor with The School of Pharmacy Trinity College Dublin.
Particular experience in an accelerated company growth environment has assisted multiple company operations; from start-up to top 10 pharma biotechs in developing and commercialising their drug product pipeline. GMACPHARMA operates on the basis of Gary’s almost 30 years of experience and through a network of associates who would have specific expertise along the drug product lifecycle; from QP to phase II to phase III/IV process development, validation and commercial supply chain operations, in particular guiding companies through there 5052B programs. GMACPHARMA have commercialised over 50 new drug products that delivered over $25Bn in revenue, putting safe and effective medicines into the hands of patients earlier, providing shareholders with double digit year on year growth – a safe pair of hands to guide companies during a high growth phase, maintaining focus on compliance whilst realising growth and efficiency opportunities. Developed a global new product introduction roadmap organisational standard approach that significantly increased the success rate from <30% to over 70% first time successful launch in 3 years following a pilot introduction. GMACPHARMA have led the development of a 300 person and over 2 billion unit pharmaceutical plant operation with over 100 SKU’s, working closely with the site senior leadership team supported closely by corporate management. GMACPHARMA have led the development of a CDMO network to develop and manufacture pharma biotech products, working closely with its client to identify the best CDMO partnerships to ensure robust development and continuity of commercial supply.
Gary has operated at a senior leadership team level for over 15 years, worked closely with high achieving CEO’s to achieve sustainable and lasting success which ultimately benefits patients, employees and shareholders alike; hiring, performance managing, mentoring and developing teams of >100 professionals in matrixed cross-functional organisations, in FDA regulatory and ERP (SAP) disciplined environments. S&OP expertise with success in streamlining the supply chain during increased complexity to significantly enhance financial and logistics visibility. We have expertise to work with you on multiple dosage forms; dry powders, dry blending, coated bead, tablet compression, capsule encapsulation (solid and liquid filing), DPI (dry powder inhalers), liquids for over the counter infant products, mainly ethical pharmaceutical drug products (Depression, Cardiovascular disease, Alzheimer’s, COPD, IBS, Ulcerative Colitis). We have particular experience in the management of the quality of Third Party CDMO execution of development and commercial projects.
GMACPHARMA has access to a panel of experts with over 100 years of collective Pharma biotech experience of FDA and EU drug product commercialisations.
Kieran Patel BSc. MSc. is BIOPHARMACEUTICALS MANUFACTURING SPECIALIST, with extensive VACCINES Drug Product and Drug Substance commercialisation manufacturing and technology expertise, Sterile fill finish and High containment operations expertise.
New product introduction, Tech transfer and product, equipment and facilities validation including project management of product, process and equipment new and existing product introduction programs through to validation and commercialisation. Adaptation of validated and qualified systems, ranging from processes and equipment systems establishing to global supply chain routes, including cold chain management.
Risk-based approach, risk assessment pFMEA and report expertise in developing tech transfer and product development strategies toward process control and capability.
Nuala Barrett B.Sc Chem. is Director of Business Development and Research and brings extensive experience of Pharma Biotech, formerly with Roche Products in the UK.
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