Director, CMC Project Management

Role Summary

Global CMC leadership across a portfolio of biologics including monoclonal antibodies, fusion proteins, and bispecifics. Accountable for CMC project and portfolio management activities working closely with CMC technical leads and cross-functional CMC teams. Requires attention to detail, forward planning, organizational skills, and effective stakeholder management to ensure seamless development of CMC plans for clinical and commercial programs.

Responsibilities

• Provide leadership to develop and maintain integrated CMC development plans across our candidate programs and pro-actively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs
• Collaborate cross-functionally to effectively monitor progress and drive CMC activities and ensure alignment with overall program goals and timelines
• Track program risks, proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success
• Support development and refinement of processes, tools, and systems to deliver high quality project management for the CMC programs
• Develop and maintain dashboards and organize and maintain documentation for CMC plans for each program
• Support Regulatory CMC with submission timelines e.g. reviews, approvals within CMC functional areas
• Champion a winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration
• Develop global CMC strategy in collaboration with CMC leads and functional teams; Proactively identify issues and drive resolution; anticipating key future events and adjusting team priorities/plans accordingly to deliver high quality results on time.

Qualifications

• Bachelor's Degree in Science or related field, or equivalent with 12 years of related work experience, or advanced degree and a minimum of 8 years of work experience
• 8+ years of experience with biologics CMC early-stage, late-stage, and lifecycle management projects
• Experience in achieving CMC objectives through an outsourced CDMO model
• Excellent communication and interpersonal skills with the ability to influence and gain consensus across multiple functions, manage a diverse set of stakeholders, and work closely with team leaders
• Strong analytical, problem solving and critical thinking skills; highly organized.
• Proven track record of successful project management of complex drug development programs in a fast-paced environment
• Project and portfolio management certificate or expertise; expertise with project management tools (e.g. Smartsheet, MS Project, dashboards)
• Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment