Senior Technical Leader, GRD CMC

Emploi pas sur LinkedIn

🕒 il y a 29 jours

🇮🇹 Italie – Télétravail

💵 €68 480 / an

⏰ Temps Plein

🟠 Senior

🧑‍💻 Développeur Full-Stack

👻 Score fantôme 0%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Chiesi Group

Site WebLinkedInTous les Emplois

5001 - 10000 employés

🏥 Santé

🏭 Fabrication

💊 Pharmaceutique

Healthcare • Manufacturing • Pharmaceuticals

Le Groupe Chiesi est une entreprise pharmaceutique mondiale axée sur la recherche, le développement et la commercialisation de médicaments innovants. Reconnu pour son engagement à améliorer la vie des patients, l'entreprise se spécialise dans des domaines tels que les maladies respiratoires, les soins spécialisés et les maladies rares. Le Groupe Chiesi met l'accent sur la durabilité et la responsabilité d'entreprise, avec pour objectif d'améliorer la santé et le bien-être à l'échelle mondiale tout en étant dédié à la gestion environnementale.

Description

• Own the budget, strategy and execution of CMC development and IMP supply projects within the GRD portfolio from candidate nomination/selection through handover to manufacturing for commercial launch • Build the overall strategic development plan in collaboration with the product core team • Develop the CMC strategy, including IMP supply, to meet project milestones and long-term business objectives • Drive execution of the CMC development plan in compliance with the regulatory strategy • Coordinate development-phase documentation packages • Lead new business development opportunity evaluations with focus on CMC • Represent GRD CMC in the project core team • Build and organize the external technical team by sourcing internal and external competences • Lead and manage external consultants and the external technical team • Hold project budget accountability for CMC activities, including CROs, CDMOs and consultancy agreements • Act as a subject matter expert and workstream lead as required • Review workstream development plans and align them with the overall strategic development plan • Provide technical support in scouting, auditing and selecting CROs/CDMOs • Lead long-term relationships with academic partners, CROs and CDMOs • Provide technical review and approval of documentation for clinical trial and market approval applications • Contribute to department development in line with GRD and GRD R&D strategic goals • Disseminate technical knowledge and leadership skills across the department and relevant adjacent functions

🎯 Exigences

• Minimum Master of Science in relevant field • Minimum 10 years of relevant industrial experience from the pharmaceutical industry • Experience from development or manufacturing of drug substances, drug products or medical devices • Highly experienced in leading and managing internal and external activities, resources, and stakeholders • Experience from regulatory interactions with EMA and/or FDA and quality module 3 documentation and requirements • Experience from working with CMOs and CROs • Good knowledge regarding GMP compliance • Good knowledge of drug development framework including regulatory guidelines, best practices and industry standards • Strong leadership and problem-solving skills • Good skills in written and verbal communication • Project leader skills • English - Fluent in verbal and written communication • Normal to experienced user of MS Office • Broad general experience in development and manufacturing of pharmaceuticals, including analytical development and testing (CGT, biologics and/or small molecules)

🏖️ Avantages

• Annual bonus scheme, subject to company and individual performance • Pension • Private medical insurance • Wellbeing programme • Flexible benefits programme • Comprehensive healthcare programs • Work-life balance initiatives • Robust relocation support • Performance bonuses • Flexible working arrangements • Remote work options • Tax assistance services for foreign colleagues • Access to resources and training • Professional development opportunities