Director, Manufacturing Sciences and Technology

Amylyx Pharmaceuticals

. Establish and lead Amylyx’s MSAT capabilities as the company prepares for commercialization .

Posted 11/6/2026full-timeCambridge • Massachusetts • United StatesLead💰 $209,000 - $235,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in MSAT capabilities, including technical transfer, process qualification, and lifecycle management, while leading high-performing teams and ensuring compliance with cGMP and regulatory standards.

Highest-signal resume keywords

MSAT LeadershipTechnical Transfer ExpertiseQuality By Design (QbD)CGMP ComplianceRegulatory Submission Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Drug Substance ManufacturingDrug Product ManufacturingProcess ValidationProcess ControlTroubleshootingRoot-Cause AnalysisTechnical WritingProcess Performance MonitoringLifecycle ManagementChange Control

Soft Skills

LeadershipCollaborationStrategic ThinkingCommunicationInfluencing Without Authority

Industry Keywords

FDA RegulationsEMA GuidelinesICH GuidelinesPharmaceutical SciencesBiological SciencesChemical EngineeringPeptidesProteinsOligonucleotidesSmall Molecules

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

BA with 10 years’ experience, or MS with 8+ years’ experience in Chemical Engineering, Biological Sciences, Pharmaceutical Sciences, or related discipline
Experience with drug substance and drug product manufacturing technologies relevant to peptides, proteins, oligonucleotides, small molecules, or other complex modalities
Ability to translate process knowledge into practical manufacturing controls
Deep expertise in Quality by Design (QbD)
Advanced knowledge of cGMP expectations and relevant FDA, EMA, ICH, and other global CMC guidance and regulatory requirements
Ability to operate independently, influence without direct authority, make sound technical decisions under ambiguity, and build trusted relationships with internal stakeholders and external partners
Excellent leadership, communication, collaboration, technical writing, and executive-level presentation skills
Strategic thinking and execution focus, with ability to translate vision into operational results
Experience leading through influence in remote and matrixed environments
High standards of quality, accountability, and urgency with resilience in a fast-paced environment
Collaborative, team-oriented approach and decisiveness as a technical leader
Ability to travel domestically and internationally up to 10%, with additional travel as business needs require
Must be able to attend meetings at Amylyx’s office in Cambridge, Massachusetts on a regular basis
Must have a suitable remote work setting with privacy, reliable internet access, phone, and video conferencing capabilities

Benefits

Comp & perks

Annual performance-based bonuses for eligible employees
Equity awards for eligible employees
Comprehensive benefits package supporting health, well-being, and financial security
Remote work opportunities within the United States
Work-from-home setting with access to privacy, reliable internet, phone, and video conferencing
Equal opportunity employer
Accommodations available for candidates who require them in the selection process