Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).
Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.
The Opportunity
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. This leader will advance Amylyx’s pipeline by aligning 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 ideal candidate combines deep global CMC expertise with organizational leadership, rigorous risk management, and hands-on problem solving in a dynamic biotechnology environment.
Responsibilities
CMC Strategy & Portfolio Leadership
- Develop and lead integrated CMC strategies across Amylyx’s preclinical, clinical, and commercial portfolio, ensuring alignment with corporate objectives and asset development plans.
- Provide strategic leadership and oversight of CMC activities from early development through late-stage clinical programs, regulatory approval, commercialization, and lifecycle management.
- Establish portfolio-level priorities, resource allocation strategies, and risk mitigation plans to support successful execution across multiple programs.
- Partner with cross-functional leadership to ensure CMC strategies support clinical development milestones, regulatory commitments, and commercial readiness.
- Anticipate and proactively address CMC challenges, dependencies, and risks that could impact development timelines, regulatory approvals, or product supply.
- Serve as a senior CMC representative in portfolio governance, asset leadership, and strategic planning discussions.
- Drive alignment and decision-making across the CMC functions to ensure coordinated execution of portfolio priorities.
Global CMC Execution & Regulatory Strategy
- Translate asset objectives into phase-appropriate, risk-based integrated CMC plans, securing functional alignment, resources, and budgets to ensure execution.
- Partner with Regulatory Affairs, Quality, and technical functions to ensure CMC strategies meet evolving regulatory requirements across the United States, Europe, Japan, and other international markets.
- Provide strategic oversight of CMC components of INDs, NDAs, MAAs, and other global regulatory submissions, including responses to health authority questions and post-approval commitments.
- Drive global CMC readiness, ensuring appropriate planning, coordination, and execution of activities required to support clinical development, regulatory approvals, and commercial launches.
- Oversee the strategic planning and coordination of CMC-related regulatory changes, commitments, and implementation activities across global markets.
- Establish effective governance, risk management, and decision-making processes to ensure timely execution of global CMC priorities.
- Collaborate with internal program teams and cross-functional stakeholders to ensure alignment of CMC deliverables with program timelines and business objectives.
Product Lifecycle Management
- Develop and oversee comprehensive CMC lifecycle management strategies to support product sustainability, global expansion, and long-term commercial objectives.
- Lead strategic planning for post-approval CMC activities, including manufacturing changes, site transfers, capacity expansion, and regulatory variations, in partnership with the responsible technical and manufacturing functions.
- Partner with Program Teams, Commercial, Supply Chain, Regulatory Affairs to support geographic expansion and evolving market requirements.
- Ensure lifecycle management plans anticipate changing regulatory requirements, supply needs, and business priorities.
- Drive cross-functional alignment on lifecycle priorities, investment decisions, and execution timelines.
- Provide strategic oversight of lifecycle initiatives to ensure effective implementation while maintaining regulatory compliance and continuity of supply.
CMC Organizational Leadership
- Lead, mentor, and develop the CMC organization, including CMC asset leaders and program management professionals, establishing clear priorities, accountability, and performance expectations.
- Build organizational capabilities and ensure the team is appropriately structured and resourced to support an expanding global pipeline and commercial portfolio.
- Provide leadership and oversight to CMC asset teams, promoting collaboration, operational excellence, and effective decision-making.
- Foster a high-performing, collaborative culture focused on scientific rigor, strategic thinking, accountability, and continuous improvement.
- Develop talent, strengthen succession planning, and support the professional growth of CMC team members.
- Partner with senior leadership on organizational planning, workforce needs, and long-term capability development.
- Promote strong cross-functional partnerships and ensure effective communication and coordination across CMC functions.
Cross-Functional Leadership & Operational Excellence
- 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 effective CMC governance, program oversight, and performance management processes to ensure consistent execution across the portfolio.
- Oversee CMC program timelines, budget assumptions, and critical milestones, ensuring transparency, accountability, and timely escalation of risks.
- Partner with technical and manufacturing leaders to align development, manufacturing, and supply strategies with broader asset and portfolio objectives.
- Drive continuous improvement in CMC planning, execution, communication, and cross-functional collaboration.
- Represent CMC in senior leadership discussions, providing clear recommendations on strategic priorities, risks, investments, and business decisions.
- Ensure effective integration of CMC activities across functions to support timely and successful achievement of program milestones.
Requirements
- Advanced degree in chemistry, chemical engineering, pharmaceutical sciences, or related scientific discipline.
- At least 15 years of progressive experience in pharmaceutical or biotechnology CMC, including significant leadership experience overseeing complex development programs and global CMC activities across the full product lifecycle.
- Demonstrated 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.
- Demonstrated expertise in CMC lifecycle management, including post-approval changes, global market expansion, comparability strategy, and regulatory commitments.
- Strong understanding of pharmaceutical development and manufacturing, with experience in both large and small molecules, preferred.
- Experience leading complex cross-functional programs and partnering effectively with Technical Development, MSAT, External Manufacturing, Regulatory Affairs, Quality, and Supply Chain.
- Strong business acumen with the ability to translate scientific, regulatory, and operational considerations into strategic business decisions.
- Demonstrated ability to establish priorities, manage competing demands, anticipate risks, and drive execution across multiple programs.
- Exceptional leadership, communication, influencing, and collaboration skills, with demonstrated effectiveness working 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%.
Work Location and Conditions:
- At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska and Hawaii.
- You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested, which may include travel by air, driving, or public transportation.
- You must have access to a work setting that meets all requirements of the role, including privacy, reliable internet access, phone, and the ability to communicate via video conference, at your remote location.
Compensation
The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.
Base salary is one component of Amylyx’s total rewards package. In addition to competitive base pay, eligible employees may receive annual performance-based bonuses and equity awards, providing an opportunity to share in the company’s long-term success. Amylyx also offers a comprehensive benefits package designed to support the health, well-being, and financial security of our employees.
Estimated Pay Range
$303,000—$341,000 USD
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Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
