Hariri Mustafa, PhD, PMP

• Portfolio Strategy: Direct end-to-end drug development strategy and operations across a diverse portfolio (cardiology, gastroenterology, dermatology, veterinary, general medicine) • Executive Oversight: Provide senior-level scientific and technical governance, ensuring strategic alignment between CMC, preclinical, clinical, regulatory, and supply functions from early to late phases.

• Asset Leadership: Acted as Chief Operating Officer for late-phase (Phase 3) and lifecycle assets, spearheading global, cross-functional vaccine development teams (20+ cross-functional members) for Meningitis and Influenza (annual budget of €100M+). • Strategic Planning: Orchestrated comprehensive asset strategy, overseeing budget management, project valuation, business cases, risk mitigation, and critical path acceleration (reducing time-to-submission by 6-9 months through smart risk taking and proactive risk mitigation). • Operational Execution: o Directed global technical, clinical and regulatory strategy and operational execution, including Phase 3 and post-approval studies, major submissions (BLA, MAA) and regulatory interactions (FDA Type C meeting, Scientific Advise). o Spearheaded global geographic expansion and regulatory strategy across 20+ countries in Europe and ROW markets.

• Program Management: Managed a strategic portfolio of injectable sterile biologics from development through commercial launch generating more than €10M in annual contract revenue. • Team Leadership: Led and mentored a team of 10+ Project Coordinators and specialized consultants, driving performance reviews, resource allocation, and personal development. • PMO Optimization: Optimized internal infrastructure by implementing advanced project management practices, risk mitigation frameworks, and executive gate reviews.

• Portfolio Execution: Managed a portfolio of up to 10 simultaneous multi-site drug product development and manufacturing projects generating around €10M in annual contract revenue.. • PMO Leadership: Built and managed a structured PMO framework, mentoring junior PMs and standardizing corporate project reporting, S-curves, and budget analysis. • Stakeholder Alignment: Served as the primary strategic liaison between the PMO, General Manager, and R&D Director, while acting as the single point of contact for key clients.

• Manage development and GMP manufacturing of multiple injectable sterile lyophilized powders and solution drug products in different packaging (vials, pre-filled syringes, auto-injectors) - simultaneously up to 10 projects (including multi-site projects) at different phases: development, clinical, validation, commercial launch • Set-up and implement project management tools and practices: MS Project, Gantt chart, Kick-off, project deliverables, action tracker, budget tracker, update report, meeting minutes, scope change, monthly report, scenario-based planning, project risk assessment • Lead and coordinate a cross-functional team (including pharmaceutical and analytical development, manufacturing, quality control, quality assurance, validation, regulatory and packaging) with daily projects monitoring • Manage communications with clients as single Point Of Contact for all aspects of the program • Write and/or review GMP documents: Change Control, SOP New Product Introduction, MBR, PPQ protocol and report, etc. • Develop strong technical knowledge on sterile manufacturing, lyophilisation, drug development, process validation, analytical methods

Aquilon is a specialty pharmaceutical company engaged in the development of drugs aiming at improving the treatment of pulmonary diseases. • Lead and manage drug development projects of inhaled formulations of liquid and dry powder dosage forms in terms of CMC (analytical and formulation development/manufacturing), as well as nonclinical (in vitro and in vivo pharmacology studies), including design, plan, interpret and report results • Project management: Gantt charts, budget and time management, meeting minutes and action items • Execute and demonstrate laboratory experiments during on-site visits (spray drying, inhalation tests etc) • Write regulatory documents on quality/CMC (IMPD) and scientific reports (experiments, business plan, grant application etc) • Contact, selection and management of contractors CDMOs and CROs • Collaborate closely with clinical team • Literature search and report: regulatory dossiers, IP/patent, scientific articles

• Principal Scientist for the company’s most innovative project: pharmaceutical development of antibiotic combinations (dry powder for inhalation) to be administered to patients with Cystic Fibrosis • Lead and manage a team of technicians on execution of laboratory activities concerning the analytical and formulation development of the project, as well as scale-up production for GMP pilot batches • Write protocol (SOP) and scientific reports, as well as contributing to the regulatory documents on quality/CMC (Module 3) • Manage the global aspect of the project with cross-functional collaboration with preclinical, clinical, regulatory affairs, QC, production teams

Thesis: “Development of new antibiotic combinations to be administered by dry powder for inhalation to patients with Cystic Fibrosis: microbiological, pharmacological and pharmaceutical studies”

Engineer's degree (Diplôme d'Ingénieur) obtained from the National Graduate School of Chemistry of Montpellier (École Nationale Supérieure de Chimie de Montpellier – ENSCM), a ‘Grande École’- which is a French highly selective academic Institute of Science and Technology.

Thesis: “Neuroprotective potentials of new formulation of Erythropoietin (EPO) in Alzheimer’s disease.”