Vice President, CMC Strategy

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the integrated strategy for Chemistry, Manufacturing, and Controls (CMC), ensuring global execution and lifecycle management across Amylyx’s preclinical, clinical, and commercial portfolio.

• Align CMC priorities with development strategies, global regulatory standards, commercialization readiness, and long-term product goals.

• Oversee the CMC asset leadership and program management team.

• Develop priorities at the portfolio level, strategies for resource allocation, and plans for risk mitigation.

• Supervise CMC activities from the initial development phase through regulatory approval, commercialization, and lifecycle management.

• Provide strategic oversight for CMC components within INDs, NDAs, MAAs, and various global regulatory submissions.

• Drive global CMC readiness, coordinating regulatory changes, commitments, and implementation efforts.

• Formulate and manage strategies for CMC lifecycle management, including manufacturing modifications, site transfers, capacity expansions, and regulatory variations.

• Lead, mentor, and cultivate the CMC organization while enhancing organizational capabilities.

• Establish governance protocols for CMC, including program oversight, risk management, and performance management processes.

• Manage timelines, budget assumptions, critical milestones, and risk escalation for CMC programs.

• Collaborate with Technical Development, MSAT, External Manufacturing, Regulatory Affairs, Quality, Supply Chain, R&D, Clinical Development, Program Management, and Commercial teams.

• Represent CMC in discussions with senior leadership, providing strategic recommendations on priorities, risks, investments, and business decisions.

• Foster continuous improvement and cross-functional alignment within CMC functions.

⛳️ Requirements

• An advanced degree in chemistry, chemical engineering, pharmaceutical sciences, or a related scientific field.

• A minimum of 15 years of progressively responsible experience in CMC within the pharmaceutical or biotechnology sectors.

• Significant leadership experience managing complex development programs and global CMC activities through the entire product lifecycle.

• Proven experience in leading CMC organizations, enhancing organizational capabilities, and managing high-performing teams.

• Extensive background in developing and executing global CMC strategies for preclinical, clinical, and commercial-stage programs.

• A successful track record in leading global regulatory submissions, product approvals, and commercial readiness initiatives.

• Strong understanding of FDA, EMA, PMDA, ICH, and relevant cGMP standards.

• Expertise in CMC lifecycle management, including post-approval changes, global market expansion, comparability strategies, and regulatory commitments.

• Comprehensive understanding of pharmaceutical development and manufacturing; experience with both large and small molecules is preferred.

• Experience in leading complex, cross-functional programs and collaborating with Technical Development, MSAT, External Manufacturing, Regulatory Affairs, Quality, and Supply Chain.

• Strong business acumen.

• Ability to prioritize effectively, manage competing demands, foresee risks, and drive execution across multiple programs.

• Exceptional leadership, communication, influencing, and collaboration skills.

• Capability to operate effectively within a dynamic and growing biotechnology organization.

• Willingness to travel internationally up to 10%.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity awards.

• Comprehensive benefits package that supports health, well-being, and financial security.

• Opportunities for remote work within the United States.

• Company-related events.

• Travel for company events and to corporate locations.

• Commitment to equal opportunity employment.

• Accommodations available for candidates requiring assistance during the selection process.