FSP RA – Client Dedicated – CMC Project Manager

🕒 il y a 5 jours

🇧🇪 Belgique – Télétravail

⏰ Temps Plein

🟠 Senior

🔴 Expert

👷‍♀️ Chef de Projet

👻 Score fantôme 10%

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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Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🏥 Santé

📦 Logistique

🏭 Fabrication

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et PPD.

Description

• Support Chemistry, Manufacturing and Controls (CMC) development for therapeutic antibodies • Plan, control, monitor, and report assigned projects with CMC leads and project teams • Manage CMC activities including process development, analytical development, product development, technical transfer, dossier development, clinical manufacturing, and project strategy • Provide technical and project leadership for client projects • Provide regulatory affairs expertise, client interface, strategic regulatory intelligence, and guidance from preclinical development through registration and product optimization • Prepare strategic, efficient client deliverables meeting local, regional, and ICH requirements • Liaise with internal and external clients • Achieve project timelines, budget, and scope goals • Translate scientific strategy into CMC project plans, visualize timelines and dependencies, and define budget needs • Track, monitor, and report milestones and decision points • Build relationships with stakeholders and monitor CMC activity progress • Perform critical-path analysis, risk assessment, and scenario simulations • Coordinate critical-path delivery, prioritize activities, and mitigate or escalate risks • Prepare and lead project team meetings, agendas, action items, and minutes • Promote collaboration, execution excellence, communication, and cross-functional problem-solving • Review and advise on regional regulatory submissions • Act as a regulatory strategy and technical subject-matter expert • Ensure quality performance and compliance with SOPs and WPDs • Manage project budgeting and forecasting • Identify out-of-scope contract activities and coordinate contract modifications • Collaborate with business development on pricing, proposals, presentations, and new business • Provide matrix/project leadership, training, and guidance to junior team members • Participate in launch, review, and project team meetings

🎯 Exigences

• Master degree in life-sciences • Previous experience comparable to 9+ years • At minimum 5 years CMC project experience • Experience working with biologics is a plus • Excellent planning and organizational skills; ability to multitask and prioritize in a multicultural environment • Strong analytical, problem-solving, and critical-thinking skills • Experience working with CMC teams and managing relationships with CMC vendors is strongly preferred • Ability to work in a dynamic, fast-growing biotech environment with challenging timelines • Quality-conscious attitude • Demonstrated project management skills and responsiveness to issues • Excellent communication skills • Ability to work in a fast-paced environment and adapt quickly to changing needs and priorities • Fluent in English • Excellent written and oral English communication skills, plus local language where applicable • Excellent attention to detail, quality, and editorial/proofreading skills • Exceptional interpersonal and liaison skills • Advanced computer skills, including Microsoft Word, Excel, and PowerPoint • Strong organizational, time-management, and planning skills • Excellent negotiation skills • Ability to work independently and exercise independent judgment • Excellent understanding of global, regional, and national regulatory requirements and regulatory affairs procedures • Expert knowledge of ICH and other global regulatory guidelines • Advanced understanding of regulatory specialty areas such as preclinical, clinical, CMC, and publishing • Superb understanding of medical terminology, statistical concepts, and guidelines • Excellent analytical, investigative, and problem-solving skills • Excellent understanding of budgeting and forecasting • In some cases, an equivalency combining appropriate education, training, and/or directly related experience may be considered sufficient

🏖️ Avantages

• Fully remote work arrangement • Standard Monday–Friday work schedule • Occasional domestic and international travel • Professional development through training and guidance to junior team members