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Vice President, CMC Strategy
Amylyx Pharmaceuticals. Lead integrated Chemistry, Manufacturing, and Controls (CMC) strategy, global execution, and lifecycle management across Amylyx’s preclinical, clinical, and commercial portfolio .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading Chemistry, Manufacturing, and Controls (CMC) strategies across the full product lifecycle, with a strong focus on regulatory submissions and organizational capability development. Proven ability to manage complex cross-functional programs and drive execution in a dynamic biotechnology environment.
Highest-signal resume keywords
CMC Strategy DevelopmentGlobal Regulatory SubmissionsLeadership in CMC OrganizationsPharmaceutical Development and ManufacturingRisk Management and Mitigation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
ChemistryChemical EngineeringPharmaceutical SciencesCMC Lifecycle ManagementRegulatory ComplianceCGMP StandardsGlobal Market ExpansionComparability StrategyProduct ApprovalsCross-Functional Program Management
Soft Skills
LeadershipCommunicationInfluencingCollaborationBusiness Acumen
Industry Keywords
FDAEMAPMDAICHBiotechnologyPharmaceuticalCommercial ReadinessPreclinical DevelopmentClinical DevelopmentLifecycle Management
About the role
Key responsibilities & impact- Lead integrated Chemistry, Manufacturing, and Controls (CMC) strategy, global execution, and lifecycle management across Amylyx’s preclinical, clinical, and commercial portfolio
- Align CMC priorities with development plans, global regulatory requirements, commercialization readiness, and long-term product strategies
- Lead the CMC asset leadership and program management organization
- Develop portfolio-level priorities, resource allocation strategies, and risk mitigation plans
- Oversee CMC activities from early development through regulatory approval, commercialization, and lifecycle management
- Provide strategic oversight of CMC components of INDs, NDAs, MAAs, and other global regulatory submissions
- Drive global CMC readiness and coordinate regulatory changes, commitments, and implementation activities
- Develop and oversee CMC lifecycle management strategies, including manufacturing changes, site transfers, capacity expansion, and regulatory variations
- Lead, mentor, and develop the CMC organization and build organizational capabilities
- Establish CMC governance, program oversight, risk management, and performance management processes
- Oversee CMC program timelines, budget assumptions, critical milestones, and risk escalation
- Partner with Technical Development, MSAT, External Manufacturing, Regulatory Affairs, Quality, Supply Chain, R&D, Clinical Development, Program Management, and Commercial teams
- Represent CMC in senior leadership discussions and provide recommendations on strategic priorities, risks, investments, and business decisions
- Drive continuous improvement and cross-functional alignment across CMC functions
Requirements
What you’ll need- Advanced degree in chemistry, chemical engineering, pharmaceutical sciences, or related scientific discipline
- At least 15 years of progressive experience in pharmaceutical or biotechnology CMC
- Significant leadership experience 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
- Proven track record leading successful global regulatory submissions, product approvals, and commercial readiness activities
- Strong understanding of 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
- Strong understanding of pharmaceutical development and manufacturing; experience in both large and small molecules preferred
- Experience leading complex cross-functional programs and partnering with Technical Development, MSAT, External Manufacturing, Regulatory Affairs, Quality, and Supply Chain
- Strong business acumen
- Ability to establish priorities, manage competing demands, anticipate risks, and drive execution across multiple programs
- Exceptional leadership, communication, influencing, and collaboration skills
- Ability to operate effectively in a dynamic, growing biotechnology organization
- Ability to travel internationally up to 10%
Benefits
Comp & perks- Annual performance-based bonuses
- Equity awards
- Comprehensive benefits package supporting health, well-being, and financial security
- Remote work opportunities within the United States
- Company-related events
- Travel to company events and corporate location
- Equal opportunity employment
- Accommodations available for candidates who require them in the selection process