Principal Research Scientist I/II / Biologics Drug Product Lead (R&D)(m/w/x)

Description

You will drive the development of innovative biological medicines by leading global strategy teams and coordinating cross-functional experts to transform scientific research into life-changing patient treatments.

Requirements

• •BS, Master's, or PhD in relevant life science
• •Bachelor's, Master's, or PhD in science related field
• •Knowledge in Biologics drug product development
• •Established expert in specific development areas
• •Understanding of major regulatory requirements
• •Experience with novel modality projects
• •Excellent communication and stakeholder management skills
• •Interpersonal skills and matrix environment leadership
• •Structured, proactive, and reliable working style
• •Comfort with ambiguity and risk-based decision-making

Tasks

• •Lead global drug product development strategy teams
• •Act as the primary contact for CMC directors
• •Develop formulations and manufacturing processes for biological assets
• •Design container closure systems for early-stage products
• •Collaborate with analytical, device, and regulatory experts
• •Connect discovery teams with toxicology and drug substance functions
• •Translate expert knowledge into patient-centric development strategies
• •Execute and communicate strategies to achieve CMC goals
• •Deliver drug product work packages for clinical phases
• •Draft regulatory submission documents including CTAs and INDs
• •Prepare briefing books for regulatory agency interactions
• •Manage technical issues with local and global experts
• •Oversee outsourced development projects with external partners
• •Communicate project risks and strategies to management
• •Plan personnel and budgetary resource requirements
• •Distribute work packages within functional development groups
• •Participate in global drug product development initiatives

Tools & Technologies

Benefits