Amylyx Pharmaceuticals

Vice President

• 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

Explore Vice President, CMC Strategy at Amylyx Pharmaceuticals. Review requirements and application details.

Vice President, CMC Strategy

Director

• Establish and lead Amylyx’s MSAT capabilities as the company prepares for commercialization
• Serve as technical owner for outsourced drug substance and drug product manufacturing
• Lead and develop a high-performing MSAT team
• Establish technical transfer, process qualification, process control, and global MSAT strategy
• Provide technical leadership across late-stage development, process validation, commercial manufacturing, continued process verification, and lifecycle management
• Lead CDMO evaluation, onboarding, technology transfer, validation, commercial manufacturing campaigns, process performance monitoring, troubleshooting, and lifecycle changes
• Partner with External Manufacturing, Quality, Regulatory CMC, Supply Chain, and manufacturing partners to resolve technical, process, and performance issues
• Identify critical path activities, technical risks, resource needs, and budget implications; develop mitigation and contingency plans
• Travel to global manufacturing and development sites to support technical transfers, GMP campaigns, and troubleshooting
• Establish and oversee process qualification policies, procedures, templates, and governance practices
• Ensure manufacturing processes are robust, scalable, continuously improved, and capable of supporting reliable supply and product quality
• Lead MSAT readiness for process validation, PPQ, commercial launch, and ongoing process monitoring
• Provide technical guidance for troubleshooting, deviation investigations, root-cause analyses, CAPAs, change controls, process performance trending, and technical impact assessments
• Review and approve CDMO technical documents, protocols, batch records, campaign plans, development reports, deviation assessments, technical memos, and manufacturing documentation
• Author, review, and defend technical content for CMC regulatory filings, agency questions, and briefing materials
• Own regulatory submission content and comparability strategy for new manufacturing sites, scale-ups, process improvements, and changes
• Mentor and develop MSAT team members, provide career guidance and feedback, plan succession, allocate resources, and build scalable technical governance and knowledge-management practices

Explore Director, Manufacturing Sciences and Technology at Amylyx Pharmaceuticals. Review requirements and application details.

Director, Manufacturing Sciences and Technology

Engineer

• Provide technical leadership and day-to-day process engineering support for clinical and commercial drug substance manufacturing at external CDMOs
• Serve as the process engineering subject matter expert during manufacturing operations, providing onsite support when required
• Lead investigations, perform root cause analysis, and develop scientifically sound CAPAs
• Author technical risk assessments and change controls for manufacturing changes, investigations, and regulatory filings
• Ensure compliance with cGMPs, global regulatory requirements, and internal quality systems
• Review and provide technical input into master batch records, campaign readiness plans, process descriptions, and manufacturing documentation
• Lead drug substance technology transfer between clinical, validation, and commercial manufacturing sites
• Define critical process parameters, critical quality attributes, and in-process controls for peptide drug substance operations
• Develop and execute process validation strategies, including PPQ planning, statistical sampling plans, and acceptance criteria
• Provide technical authorship and review for IND, BLA, NDA, and MAA submissions, validation reports, and regulatory responses
• Support drug substance introductions and commercial launches by ensuring processes are validated, scalable, robust, and inspection ready
• Lead continued process verification and routine data trending
• Develop and maintain data repositories, dashboards, and KPIs to assess process capability, performance, and trends
• Identify process drift, yield loss, impurity shifts, raw material variability, and scale-dependent risks; drive corrective or preventive actions
• Prepare and present quarterly CPV summaries and technical assessments for management reviews
• Execute continuous improvement initiatives focused on process robustness, impurity control, yield, cycle time, capacity, and operational efficiency
• Apply Quality by Design, Design of Experiments, statistical process control, and risk-based decision making
• Collaborate with CDMOs to implement best practices, new technologies, and process enhancements

Explore Senior Process Engineer, MSAT, Drug Substance at Amylyx Pharmaceuticals. Review requirements and application details.

Open roles

Vice President, CMC Strategy

Director, Manufacturing Sciences and Technology

Senior Process Engineer, MSAT, Drug Substance