CMC Senior Project Lead, Global Biologics Manufacturing Sciences

Role Summary

Join us as our CMC Sr. Project Lead, Global Biologics Manufacturing Sciences (GMsci Bio) and play a pivotal role in advancing our biologics portfolio. In this role you will provide project management expertise for strategic initiatives and Chemistry, Manufacturing and Controls (CMC) Life Cycle management (LCM) activities, utilizing technology platforms to efficiently gather project data and deliver actionable insights through effective visualization and reporting.

Responsibilities

• Co-lead CMC project teams for complex biologic products and guide CMC teams with the CMC lead.
• Lead Global Technology Transfer Projects
• Ensure timely execution of CMC LCM strategies to ensure supply continuity, risk management, and global launch execution.
• Make data-driven decisions to optimize project plans.
• Develop cross-functional plans, oversee project budgets, and estimate resources for successful project completion.
• Apply agile principles to streamline business processes and enhance organizational capacity.
• Mentor and develop project management talent within the organization.

Qualifications

• BS/MS in engineering, life sciences, or related field.
• Minimum of 5-year experience within CMC related environment.
• Strong background within biotech or pharma industry.
• Expert in Microsoft 365 and PM tools (MSP, Smartsheet,‚Ķ)
• Strong knowledge of Agile, Lean, DMAIC, Waterfall, PMBOK methodologies.
• Strong grasp of organizational development and cross-functional alignment.
• Fluent English required; Mandarin proficiency beneficial.
• Confident in timely reporting/escalation.
• Proficient in project infrastructure.
• Previous experience in global matrixed organizations with Asian cultural acumen beneficial.
• Proven experience leading Global and Local cross-functional teams with effective communication and collaborative approach.
• Understanding of technical dimensions of regulatory submissions and tech transfer, with previous experience in both.

Skills

• Project management expertise for strategic initiatives and CMC LCM activities
• Data gathering, visualization, and reporting through technology platforms
• Global technology transfer and cross-functional collaboration
• Agile, Lean, and PMBOK methodologies
• Cross-cultural communication and leadership in matrixed organizations

Education

• BS/MS in engineering, life sciences, or related field