FSP RA – Client Dedicated – CMC Project Manager

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Assist in the development of Chemistry, Manufacturing and Controls (CMC) for therapeutic antibodies

• Organize, oversee, track, and report on assigned projects in collaboration with CMC leads and project teams

• Oversee CMC activities such as process development, analytical development, product development, technical transfer, dossier creation, clinical manufacturing, and project strategy

• Provide technical leadership and project guidance for client initiatives

• Offer expertise in regulatory affairs, client interactions, strategic regulatory insights, and support from preclinical stages through to registration and product optimization

• Develop strategic and efficient client deliverables that comply with local, regional, and ICH standards

• Serve as a point of contact between internal and external clients

• Meet project deadlines, budget constraints, and scope objectives

• Convert scientific strategy into actionable CMC project plans, visualize timelines and dependencies, and outline budget requirements

• Monitor, track, and report on milestones and decision-making points

• Foster relationships with stakeholders and keep track of CMC activity progress

• Conduct critical-path analyses, risk assessments, and scenario simulations

• Coordinate critical-path deliveries, prioritize tasks, and manage or escalate risks

• Organize and facilitate project team meetings, including agendas, action items, and minutes

• Encourage collaboration, excellence in execution, communication, and cross-functional problem-solving

• Review and provide guidance on regional regulatory submissions

• Act as a subject-matter expert in regulatory strategy and technical matters

• Ensure adherence to quality performance standards and compliance with SOPs and WPDs

• Oversee project budgeting and financial forecasting

• Identify contract activities that fall outside the agreed scope and manage contract modifications

• Collaborate with business development on pricing, proposals, presentations, and new business opportunities

• Provide leadership, training, and support to junior team members within a matrix/project framework

• Engage in launch, review, and project team meetings

⛳️ Requirements

• Master's degree in life sciences

• Relevant experience of at least 9 years

• A minimum of 5 years of CMC project experience

• Experience with biologics is advantageous

• Exceptional planning and organizational capabilities; skilled in multitasking and prioritizing in a diverse environment

• Strong analytical, problem-solving, and critical-thinking abilities

• Preferred experience with CMC teams and managing relationships with CMC vendors

• Capacity to thrive in a dynamic, fast-paced biotech setting with tight deadlines

• Quality-focused mindset

• Proven project management skills and responsiveness to challenges

• Excellent communication abilities

• Capability to operate in a fast-paced environment and quickly adapt to evolving needs and priorities

• Proficiency in English

• Strong written and verbal communication skills in English, along with local language proficiency where applicable

• Exceptional attention to detail, quality, and editorial/proofreading skills

• Outstanding interpersonal and liaison capabilities

• Advanced computer proficiency, including Microsoft Word, Excel, and PowerPoint

• Strong organizational, time-management, and planning skills

• Excellent negotiation abilities

• Ability to work autonomously and exercise independent judgment

• Comprehensive understanding of global, regional, and national regulatory requirements and processes

• In-depth knowledge of ICH and other international regulatory guidelines

• Advanced comprehension of regulatory specialty areas, including preclinical, clinical, CMC, and publishing

• Strong grasp of medical terminology, statistical concepts, and guidelines

• Excellent analytical, investigative, and problem-solving skills

• Solid understanding of budgeting and forecasting processes

• In certain cases, an equivalent combination of relevant education, training, and/or related experience may be deemed sufficient

🏝️ Benefits

• Fully remote work option

• Standard work hours from Monday to Friday

• Occasional travel for domestic and international assignments

• Opportunities for professional development through training and mentorship for junior team members