Director, CMC Product Lead

The Role

The CMC Product Lead is a critical strategic role within the CMC organization, tasked with the oversight and execution of CMC strategies for multiple assets across therapeutic areas from first in human to pivotal studies. The CMC Product Lead ensures seamless integration of program strategy with the Target Product Profile (TPP) and Quality Target Product Profile (QTPP), and is also responsible for translating Core Team (R&D and/or Commercial) strategies into actionable CMC plans.

This role will also be a key interface with our Resilience manufacturing sites. With a comprehensive understanding of drug development, the role requires technical expertise, leadership skills, ability to translate complex messages across multiple altitudes, and a robust command of situational complexity and ambiguity to effectively manage CMC plans. The CMC Product Lead is expected to thrive in leading through complex situations, demonstrate accountability, engage in cross-functional debate, and embrace differences in opinion.

The ideal candidate will display keen judgment, executive presence, and the ability to develop self and team members continually.

• Define and communicate strategic CMC Development Plans for products in a therapeutic area, ensuring alignment with the TPP and QTPP.
• Translate platform and program strategy into actionable, achievable CMC tasks and milestones, prioritizing the portfolio in alignment with enterprise priorities.
• Serve as a key member of Program Team, representing CMC and working under the guidance of the Leadership Team (LT).
• Act as the primary point of accountability for the CMC plan, making critical decisions and serving as a resource to key leadership.
• Engage in technical discussions, own technical roadmap for program implementation and contribute to CMC sections of global regulatory submissions.
• Expert technical storytelling skills across multiple altitudes.
• Lead CMC team in discussions with key leadership, R&D teams, and internal governance bodies.
• Identify and address cross-functional gaps and risks, escalating issues appropriately to drive progress.
• Accountable for the strategy of the resource and financial management of the team, including budgeting, resource allocation and cost management
• Empower and delegate to team members/workstream leads, establishing credibility by diving into the appropriate level of detail when necessary.
• Engage the audience with the right content, balancing engagement based on risk and value.
• Build and maintain strong relationships across the organization, including with cross-functional stakeholders for facilitating strategic handshakes for effective lifecycle management.

• PhD with 10+ years, MS with 12+ years, or BS/BA 15+ years of relevant experience.
• Proven leadership experience in CMC or product development organizations within the biotechnology/pharmaceutical industry.
• Strong knowledge of CMC-related activities, including Technical Development, Manufacturing, Supply Chain, Quality, Process Development, and CMC Regulatory.
• Demonstrated ability to lead cross-functional teams and complex projects with strategic and operational impact.

• PhD in relevant field such as Biochemistry, Chemistry, Biology, Pharmaceutical Sciences
• Demonstrates sufficient technical depth in drug development to inform overall CMC strategy
• Financial/business acumen and executive influence with strong stakeholder management skills at all levels.
• Demonstrates leadership quality, poise, flexibility, adaptability, and superb written and verbal communication skills.
• Cross-functional influence, negotiation skills, and a champion of effective decision-making…