Senior Manager, Biologics CMC Project Management

Location: Wilmington, Delaware, United States; occasional international travel to partners and CMO facilities may be required.

Company

Biopharmaceutical organization developing biologics programs through cross-functional technical operations, regulatory, quality, supply chain, and external partner activities.

What you will do

• Coordinate cross-functional project activities for biologics CMC programs, workstreams, and initiatives.
• Develop and maintain integrated project plans covering CMC, regulatory, technical, and operational activities.
• Track risks, issues, dependencies, critical-path activities, resources, budgets, and mitigation actions.
• Prepare governance materials with program status, scenarios, risks, options, and proposed next steps.
• Coordinate plans, deliverables, risks, and milestones with CMOs, CROs, and other external collaborators.
• Maintain dashboards, timelines, SharePoint sites, submission-related schedules, and life-cycle management tracking.

Requirements

• Relevant experience supporting or managing cross-functional biologics product development projects, workstreams, or deliverables.
• Experience coordinating CMC project activities in the pharmaceutical or biotech industry.
• 4–6 years of project management and/or product development experience in the pharmaceutical or biotech industry, or equivalent experience.
• Degree such as BS, MS, or PhD in Biological Sciences or a related discipline, or equivalent experience.
• Strong project management, communication, facilitation, presentation, organizational, and problem-solving skills.
• Willingness to travel internationally as needed to partners and CMO facilities.

Nice to have

• Understanding of phase-appropriate CMC development and regulatory submission requirements.
• Experience with resource tracking, budget inputs, and program reporting.
• Experience with monoclonal antibody drug development.
• PMP certification and a strong technical background.

Culture & Benefits

• Collaborative environment involving Technical Operations, Discovery, Regulatory Affairs, Quality, Supply Chain, and external partners.
• Opportunities to support onboarding, knowledge sharing, best practices, and continuous improvement.
• Accommodations are available for individuals with disabilities during required travel.
• Work includes adapting to changing organizational structures and managing multiple priorities.