Lucia Apparente
Analytical Development Senior Specialist @Dompé
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WORK HISTORY
Analytical Development Senior Specialist @Dompé
Napoli, IT
Lead and coordination of analytical scientists team with a broad range of expertise in small and large molecules development and characterization.Develop robust, detailed plans for drug substance and drug products characterization using innovative techniques.Design, plan and oversee stability protocols for evaluating drug products compatibility with primary packaging in different storage conditions.Optimization of manufacturing processes of biotech drug products.Establishment and management of collaborative relationships with academic partners, CDMOs and CROs in Europe and USA, to discover and develop new innovative platform for drugs delivery.In charge of development and documentation of study protocols, data review, interpretation and record of analyses outcomes.Contribute to define budgets and new technologies investments for the R&D Technology department.Actively participate with the IP department to the realization of patentability strategies of new drug productsLearning owner of new resources of the R&D Technology department.
EDUCATION
Università degli Studi 'Gabriele d'Annunzio' di Chieti
Dottorato di ricerca in Scienze e Tecnologie Farmaceutiche
IKN Italy
Certificazione, Progettare e impostare un piano di Convalida dei Metodi Analitic
GLC europe
Certification, Chimica farmaceutica e medicinale
Cork English College
Cultural Exchange supported by European Community
Università degli Studi 'Gabriele d'Annunzio' di Chieti
Dottorato di ricerca in Scienze Biomolecolari e Farmaceutiche, Scienze biomolecolari e farmaceutiche
Università degli Studi di Napoli Federico II
Bachelor's degree, Chimica e Tecnologia Farmaceutica
ALMA LABORIS Business School
Master di Alta Formazione, Pharma Medical Affairs e Direzione Medica
INK Italia
Certificazione, Technology Transfer primario e secondario
Università degli Studi di Napoli Federico II
Neuropharmacology Ph.D. winner at University Federico II, Naples
SKILLS
ABOUT LUCIA APPARENTE
Analytical Development Senior Scientist with more than 12 Y of experience in drug discovery,drug development and drug products characterization in pharmaceutical companies. Seniorresearcher of the R&D team that has successfully developed and commercialized drugproducts for rare disease treatments. More than 2 Y in leading the progression of new projectsfrom the proposal stage through project completion. Achieved great results in scoutingexternal research collaborations and establishing the project objectives, timelines anddeliverables for the R&D team. Hard skills: extensive and broad analytical sciencebackground, GMP background, experience with method validations and transfers, regulatorysubmissions, patent submissions and project management for analytical methods and pre-formulative studies. Soft Skills: critical thinking, skilled in coordinating activities to ensuredeadlines are met, working under pressure, troubleshooting and problem solving-skills. PhD inPharmaceutical Sciences at Università di Chiesi Gabriele D’ Annunzio and Master in MedicalAffairs and Medical Management at Alma Laboris Business School. Continuously improving theknowledge of English language by attending international conferences and English
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