Client Dedicated Project Manager

• 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

• 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

• 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