Senior Technical Leader, Protein Biologics Development

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

• Act as senior subject matter expert for protein biologics drug substance development • Lead or contribute to CMC strategies from candidate selection through clinical supply, technology transfer, process characterization, validation, regulatory submission, launch, and lifecycle management • Provide expert guidance on expression systems, cell line development, clone selection, cell banks, media and feed development, upstream process development, harvest, clarification, purification, impurity clearance, scale-up, and process control • Translate protein structure, function, expression, process parameters, and analytical data into risk-based CMC strategies and practical development decisions • Lead identification and management of critical and key product quality attributes • Drive phase-appropriate control strategies covering process parameters, in-process controls, release testing, characterization, comparability, specifications, and lifecycle knowledge management • Lead technical risk assessments, process change assessments, comparability strategies, troubleshooting, investigations, deviations, CAPAs, and continuous improvement activities • Lead scientific and technical discussions with internal stakeholders, CDMOs, CROs, academic partners, and external consultants • Support selection, evaluation, and oversight of external development and manufacturing partners • Contribute to technical and regulatory documentation, business development and due diligence assessments, and GRD CMC ways of working for protein biologics • Lead extended technical teams and ensure CMC strategies, plans, budgets, timelines, risk assessments, and key decisions align with objectives and regulatory, quality, and lifecycle requirements • Build and retain deep product and process knowledge within GRD

🎯 Exigences

• University degree in biotechnology, biochemistry, biochemical engineering, cell biology, molecular biology, pharmacy, or a related discipline • Advanced degree is an advantage • Significant industrial experience in biologics CMC development • Deep expertise in recombinant protein drug substance development, protein expression, and manufacturing • Strong understanding of upstream and downstream processing, protein characterization, analytical control strategies, GMP, regulatory expectations, comparability, validation, and lifecycle management • Experience working with CDMOs, CROs, academic partners, external consultants, and outsourced development or manufacturing models • Proven ability to lead extended technical teams, coordinate cross-functional activities, influence stakeholders, and translate complex technical data into clear recommendations, risk assessments, and decision points • Excellent written and verbal communication skills in English

🏖️ 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 • Relocation support • Flexible working arrangements • Remote work options • Tax assistance services for foreign colleagues • Access to resources and training • Performance bonuses • Benefits benchmarked against the external market