Senior Technical Leader, Analytical Method Development and Validation

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

• Provide scientific and technical leadership for analytical method development, method qualification and validation, analytical control strategy, comparability, technology transfer, stability strategies, and lifecycle activities • Lead an extended technical team and align analytical CMC deliverables with project objectives, regulatory expectations, quality requirements, timelines, and budget • Build and retain product knowledge within GRD to support decision-making and external partner oversight • Act as subject matter expert for analytical method development, qualification and validation, analytical control strategy, comparability, stability, and related CMC areas for biological products such as protein therapeutics • 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 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 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

🎯 Exigences

• A university degree in biotechnology, biochemistry, chemistry, biology, pharmacy, engineering, or a related scientific discipline; an advanced degree is an advantage • Significant experience in analytical method development, method qualification and validation for biologics • Experience with analytical control strategy, stability testing, comparability, technology transfer, or lifecycle management within CMC development • Strong scientific understanding of analytical techniques relevant to biologics development, including assay performance, robustness, method lifecycle, data interpretation, and regulatory expectations for validated methods • Strong understanding of GMP, regulatory expectations, quality systems, and development requirements for clinical and/or commercial manufacturing • Experience working with CDMOs, CROs, external partners, or outsourced development and manufacturing models • Ability to translate complex technical information into clear recommendations, fit-for-purpose plans, and practical decisions • Experience leading technical discussions, coordinating cross-functional activities, and influencing stakeholders in a matrix environment • Excellent written and verbal communication skills in English • Proactive, solution-oriented, and comfortable taking responsibility in situations where priorities may evolve

🏖️ 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