Director, Biologics Development – Commercialization Team Lead

• Deliver a fully integrated stage-appropriate CMC development and commercialization strategy
• Advance the company's biologics portfolio
• Responsible for on-time, end-to-end execution of DCT deliverables
• Lead DCT and critically assess all team deliverables
• Prioritize, interrogate and mitigate risks across all factors impacting success or timelines
• Analyze and develop innovative solutions
• Ensure the best science and robust processes are used
• Conduct options analysis and provide recommendations to governance
• Represent CMC and effectively communicate across governance bodies, stakeholders and teams
• Drive outcomes/decisions through influence, advocacy, & negotiation with stakeholders
• Identify options to balance speed, cost, robustness & achieve target commercial product

Requirements

• Bachelor of Science (BS) Degree in relevant engineering or science fields with fifteen (15) years of relevant experience, or Master of Science (MS) Degree with twelve (12) years of relevant experience, or PhD with ten (10) years relevant experience
• Strong cross divisional networking skills and capabilities
• Demonstrated functional and enterprise leadership, ability to influence at all levels of the organization
• Strong collaborative skills and the ability to work strategically and in a detail-oriented framework with all levels of management
• Must have strong understanding of product management systems and tools, strong business and financial skills, ability to manage multiple programs and create a high-performance work environment

Core Competencies

Demonstrates expertise in CMC development and commercialization strategies, with a strong focus on risk mitigation, stakeholder communication, and innovative problem-solving. Proven ability to lead cross-functional teams and manage multiple programs effectively while ensuring alignment with business objectives.

Highest-signal resume keywords

• CMC Development Strategy
• Cross Divisional Networking
• Product Management Systems
• Enterprise Leadership
• Stakeholder Communication

ATS Optimization Keywords

Hard Skills

• Biologics Portfolio Management
• Options Analysis
• Risk Mitigation
• Innovative Solution Development
• Program Management

Soft Skills

• Collaborative Skills
• Influencing Skills
• Detail-Oriented Framework
• Advocacy
• Negotiation

Certifications & Qualifications

• Bachelor of Science (BS)
• Master of Science (MS)
• PhD

Industry Keywords

• DCT Deliverables
• Governance Bodies
• High-Performance Work Environment
• Commercial Product Target
• Business and Financial Skills