FSP RA – Client Dedicated – CMC Project Manager

🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👷‍♀️ Project Manager

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and 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

🎯 Requirements

• 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

🏖️ Benefits

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