Client Dedicated Project Manager

🔥 17 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👷‍♀️ Project Manager

👻 Ghost score 12%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Support Chemistry, Manufacturing and Controls (CMC) development for therapeutic antibodies • Plan, control, monitor, and report assigned projects in collaboration with CMC Leads and project teams • Coordinate process development, analytical development, product development, technical transfer, dossier development, clinical manufacturing, and project strategy activities • Provide technical and project leadership for a client project • Provide regulatory affairs expertise, strategic regulatory intelligence, and guidance from preclinical development through registration and product optimization • Prepare client deliverables meeting local, regional, and ICH regulatory and technical requirements • Act as liaison with internal and external clients • Achieve project goals for timelines, budget, and scope • Translate scientific strategy into CMC project plans, including timelines, dependencies, and budget needs • Track, monitor, and report milestones and decision points • Build relationships with internal and external stakeholders and monitor CMC activity progress • Perform critical-path analysis, risk assessment, and scenario simulations • Coordinate critical-path items, 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 • Provide regulatory strategy advice and technical expertise to internal and external clients • Ensure quality performance and compliance with organizational and regulatory 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, budgets, presentations, and new business • Provide matrix/project leadership, training, and guidance to junior team members • Participate in launch, review, and project team meetings

🎯 Requirements

• Master degree in life-sciences • Previous experience providing the knowledge, skills, and abilities to perform the job, 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 operate in a dynamic, fast-growing biotech environment with challenging timelines • Quality-conscious attitude • Demonstrated project management skills and responsiveness to issues • Excellent communication skills • Self-starter able to work in a fast-paced environment and adapt 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, editorial, and proofreading skills • Exceptional interpersonal 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 • Occasional ability to drive to site locations and travel domestically and internationally

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Opportunity to work on innovative therapeutic antibody development and new medicines • Global team environment • Professional training and guidance from senior team members • Exposure to international projects and occasional international travel

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