01
Inspection Readiness
A well-proven roadmap to install inspection excellence into the organisational culture.
GMAC Pharma · Dublin
A consultancy that puts patients above all.
Business compliance leadership of next-generation medicines manufacturing.
Led by
Gary McAuslan
MBA · BSc · Dip. Business · Adjunct Professor
A consultancy that does more than just advise
Services
Giving you a better understanding of our expertise.
02
Delivery of Next-Generation Manufacturing Assets
The assembly, commissioning and qualification of pharmaceutical manufacturing facilities, utilities, infrastructure and manufacturing technologies.
03
Drug Pipeline Approval & Commercialisation
Accelerated, compliant development for late-stage Phase II/III/IV products, specialising in difficult-to-develop candidates. PAI preparation, dossier strengthening and continued process verification for FDA and EU approvals, launch and ongoing supply.
04
Make-or-Buy & Fast-Track Modular Build
Preparing and executing in-house facility expansion and outsourcing strategy in line with pipeline growth. Make-or-buy analysis, best-fit CDMO partner selection, and fast-track modular build design to unlock commercialisation opportunities that would otherwise be out of reach.
05
Acquisition & Due Diligence Support
Preparing the organisation for compliant growth leading to a successful funding round, sale or IPO. Organisational right-sizing, capacity alignment, change implementation and maximising value perception of drug and pipeline assets — CMC, compliance and operational readiness.
“
Bringing economically viable next generation medicines to more patients.
Gary McAuslan · Founder & Managing Director
Meet the founder
Gary McAuslan.
MBA · BSc · Dip. Business · Adjunct Professor
Gary McAuslan is the founder, owner and managing director of GMAC Pharma — a specialist consultancy he built out of Trinity College Dublin's MBA programme in 2014 and has grown into a trusted partner for pharma and biotech companies across Europe.
He is a Business Compliance Leader of next-generation mAbs, GLP-1 OSD and Cell & Gene Therapy manufacturing platform assets — expanding patient access through process intensification using AI-assisted, risk-reduced single-use and digitised automation.
His Manufacturing Asset Playbook approach delivers mega programmes that make novel medicines available to patients with unmet needs. Gary has raised over €85M for new ventures and conversions, and today co-authors the Playbook driving a €3Bn mAbs platform investment across two state-of-the-art multi-product plants.
Across a 35+ year career at Roche, Merck, AbbVie, Lonza, aCGT Vector and Eli Lilly, he has led manufacturing organisations of 230+ people producing over two billion units annually to FDA and MHRA standards. As Adjunct Professor at Trinity College Dublin's School of Pharmacy he connects the M.Pharm Masters programme with modern CAR-T and CRISPR cellular therapy manufacturing.
Gary is passionate about CMC commercialisation and the evolving area of ATMP precision medicines — helping overcome the manufacturing bottleneck restricting patient access to Cell & Gene Therapies and Vaccines. Working knowledge spans SAP, Delta V, eBR, Tulip, Veeva and Kneat for electronic C&Q execution.
Capabilities
Working within your site leadership team to develop and commercialise drug manufacturing.
€85M+
Raised for new ventures & conversions
35+ yrs
Pharma & biotech leadership
€3Bn
mAbs platform programme in flight
2B+
Patients treated from products developed under his leadership
AI-Accelerated Pipeline
Using best-practice AI to fast-track drug substance and drug product pipeline commercialisation.
Career
Three decades — global leadership
2025 — Present
Eli Lilly and Company
Business Quality Site Expansion Lead
Leading the Inspection Excellence Program across a €3Bn capital investment establishing state-of-the-art multi-product mAbs platform manufacturing plants — including a €1.6Bn digitally native site supporting Alzheimer's treatment Donanemab.
2014 — Present
GMAC Pharma Ltd
Principal Consultant & Managing Director
CMC expertise from late-stage development to commercial manufacturing, packaging, serialisation and funding — early engagement toward first-time-right commercialisation.
2018 — Present
Trinity College Dublin
Adjunct Professor, School of Pharmacy
Connecting the M.Pharm Masters programme with industry — CAR-T, CRISPR and modern cellular therapy manufacturing modalities.
2020 — 2025
aCGT Vector
Founder & CEO
Cell & gene therapy company increasing patient access to precision medicines via standardised, digitised, closed-system POD platforms co-located in hospitals.
2015 — 2017
Lonza — Edinburgh
Director, Site Operations
GMP compliance leadership during commercialisation of a strong R&D pipeline of hard gelatine pharma biotech products to MHRA and FDA standards.
1996 — 2013
AbbVie
Global Technical Services Director / Operations Director
Led manufacturing across two Dublin plants — 230 people, 2 billion+ units annually of FDA-approved OSD and dry powder inhaler products for IBS, COPD, Asthma, Cardiovascular and Alzheimer's indications.
Let's build what's next.
Whether you are establishing your manufacturing footprint or preparing for PAI, GMAC Pharma will partner with you on the journey from strategy to execution.