Vice President, CMC Strategy

Amylyx Pharmaceuticals

3h • $303,000 - $341,000 • Remote

About The Position

Amylyx is seeking an experienced and strategic Vice President, CMC Strategy to lead integrated Chemistry, Manufacturing, and Controls (CMC) strategy, global execution, and lifecycle management across the company’s preclinical, clinical, and commercial portfolio. The role aligns CMC priorities with development plans, global regulatory requirements, commercialization readiness, and long-term product strategies. The Vice President will lead the CMC asset leadership and program management organization and partner closely with Technical Development, Manufacturing Sciences and Technology (MSAT), External Manufacturing, Regulatory Affairs, Quality, Supply Chain, Clinical Development, Program Management, and Commercial teams. The role calls for deep global CMC expertise, organizational leadership, rigorous risk management, and hands-on problem solving in a dynamic biotechnology environment.

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The position is remote within the United States, subject to state restrictions; Alaska and Hawaii residents are not being considered. The employee will travel to the company’s Cambridge, Massachusetts location several times per year and to other company events as needed. International travel of up to 10% is required. The remote work setting must provide privacy, reliable internet, phone access, and the ability to communicate by video conference.

The estimated base salary range is $303,000–$341,000 USD. Eligible employees may also receive annual performance-based bonuses and equity awards. Amylyx offers a comprehensive benefits package.

Requirements

• Advanced degree in chemistry, chemical engineering, pharmaceutical sciences, or a related scientific discipline.
• At least 15 years of progressive pharmaceutical or biotechnology CMC experience, including significant leadership overseeing complex development programs and global CMC activities across the full product lifecycle.
• Experience leading CMC organizations, developing organizational capabilities, and managing high-performing teams.
• Extensive experience developing and executing global CMC strategies across preclinical, clinical, and commercial-stage programs, including CMC asset leadership and program team representation.
• Proven track record leading successful global regulatory submissions, product approvals, and commercial readiness activities.
• Strong understanding of global CMC regulatory requirements, including FDA, EMA, PMDA, ICH, and applicable cGMP standards.
• Expertise in CMC lifecycle management, including post-approval changes, global market expansion, comparability strategy, and regulatory commitments.
• Experience leading complex cross-functional programs and partnering effectively with Technical Development, MSAT, External Manufacturing, Regulatory Affairs, Quality, and Supply Chain.
• Strong business acumen and ability to translate scientific, regulatory, and operational considerations into strategic business decisions.
• Ability to establish priorities, manage competing demands, anticipate risks, and drive execution across multiple programs.
• Exceptional leadership, communication, influencing, and collaboration skills, including effectiveness across functions and with senior executives.
• Ability to operate effectively in a dynamic, growing biotechnology organization and balance strategic priorities with operational execution.
• Ability to travel internationally up to 10%.
• Ability to work remotely from a setting with privacy, reliable internet, phone access, and video-conferencing capability; travel to Cambridge, MA several times a year and to other company events as needed.

Nice To Haves

• Experience with both large and small molecules.

Responsibilities

• Develop and lead integrated CMC strategies across the preclinical, clinical, and commercial portfolio, aligned with corporate objectives and asset development plans.
• Provide strategic oversight of CMC activities from early development through late-stage clinical programs, regulatory approval, commercialization, and lifecycle management.
• Set portfolio priorities, resource allocation strategies, and risk mitigation plans across programs.
• Partner with cross-functional leaders to align CMC strategies with clinical milestones, regulatory commitments, and commercial readiness.
• Anticipate and address CMC challenges, dependencies, and risks that could affect timelines, approvals, or product supply.
• Represent CMC in portfolio governance, asset leadership, and strategic planning discussions, and drive coordinated decision-making across CMC functions.
• Translate asset objectives into phase-appropriate, risk-based integrated CMC plans, securing functional alignment, resources, and budgets.
• Partner with Regulatory Affairs, Quality, and technical functions to meet evolving CMC regulatory requirements across the United States, Europe, Japan, and other markets.
• Oversee CMC components of INDs, NDAs, MAAs, and other global regulatory submissions, including health authority responses and post-approval commitments.
• Lead global CMC readiness planning and execution for clinical development, regulatory approvals, and commercial launches.
• Oversee planning and coordination of CMC-related regulatory changes, commitments, and implementation across global markets.
• Establish governance, risk management, and decision-making processes for timely execution of global CMC priorities.
• Develop and oversee CMC lifecycle strategies for product sustainability, global expansion, and long-term commercial objectives.
• Lead planning for post-approval CMC activities, including manufacturing changes, site transfers, capacity expansion, and regulatory variations, with the responsible technical and manufacturing functions.
• Partner with Program Teams, Commercial, Supply Chain, and Regulatory Affairs on geographic expansion and changing market requirements.
• Align lifecycle priorities, investment decisions, execution timelines, regulatory needs, supply needs, and business priorities; oversee implementation while maintaining compliance and continuity of supply.
• Lead, mentor, and develop CMC asset leaders and program management professionals, setting priorities, accountability, and performance expectations.
• Build organizational capabilities and ensure the team is structured and resourced for an expanding global pipeline and commercial portfolio.
• Oversee CMC asset teams and foster collaboration, operational excellence, effective decision-making, scientific rigor, strategic thinking, accountability, and continuous improvement.
• Develop talent, strengthen succession planning, support professional growth, and partner with senior leadership on organizational planning, workforce needs, and long-term capabilities.
• Serve as a strategic partner to Technical Development, MSAT, Regulatory Affairs, Quality, Supply Chain, External Manufacturing, R&D, Clinical Development, Program Management, and Commercial teams.
• Establish CMC governance, program oversight, and performance management processes across the portfolio.
• Oversee CMC program timelines, budget assumptions, and milestones, ensuring transparency, accountability, and timely escalation of risks.
• Align development, manufacturing, and supply strategies with asset and portfolio objectives.
• Improve CMC planning, execution, communication, and cross-functional collaboration.
• Represent CMC in senior leadership discussions and provide recommendations on priorities, risks, investments, and business decisions.
• Integrate CMC activities across functions to support timely achievement of program milestones.

Benefits

• Eligible employees may receive annual performance-based bonuses and equity awards.
• Comprehensive benefits package designed to support employee health, well-being, and financial security.
• Remote work opportunities within the United States, subject to location restrictions.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive