Director, Manufacturing Sciences and Technology (MSAT)

The Opportunity

Amylyx is seeking a Director, Manufacturing Sciences and Technology to establish and lead MSAT capabilities as the company prepares for commercialization. This leader will serve as the technical owner for outsourced drug substance and drug product manufacturing, with accountability for process robustness, scalability, process validation, continued process verification, and lifecycle management in close partnership with External Manufacturing, Quality, Regulatory CMC, Supply Chain, and manufacturing partners.

The ideal candidate will bring strong MSAT experience with the ability to operate both strategically and hands-on in a small, fast-moving biotech environment that relies heavily on external manufacturing partners. This leader will have demonstrated success leading technology transfers, process validation, manufacturing support, and operational excellence through influence and cross-functional partnership. This role reports to the Senior Vice President, CMC and External Manufacturing.

Responsibilities

MSAT Strategy & Technical Leadership:

• Lead and develop a high performing MSAT team establishing robust technical transfer, process qualification, and process control processes.
• Act as a technical subject matter expert when needed while leading and coaching team members across technology transfer, manufacturing support, and troubleshooting to drive operational excellence.
• Establish the global MSAT strategy and provide technical leadership across late-stage development, process validation, commercial manufacturing, continued process verification, and lifecycle management.
• Provide technical leadership for CDMO evaluation, onboarding, technology transfer, validation, commercial manufacturing campaigns, process performance monitoring, troubleshooting, and lifecycle changes across drug substance and drug product manufacturing.
• Partner with External Manufacturing and Quality leadership to resolve technical, process, and performance issues.
• Proactively identify critical path activities, technical risks, resource needs, and budget implications; develop practical mitigation plans and contingency strategies in collaboration with internal and external teams.
• Travel to global manufacturing and development sites as needed to support technical transfers, GMP campaigns, and troubleshooting.

Process Validation & Manufacturing Performance

• Establish and oversee process qualification policies, procedures, templates, and governance practices that enable consistent PPQ execution, continued process verification, technical risk management, and commercial manufacturing readiness across Amylyx and its external manufacturing network.
• Ensure manufacturing processes are operationally robust, scalable, and continuously improved to support reliable supply, product quality, patient needs, and business growth.
• Lead MSAT readiness for process validation, PPQ, commercial launch, and ongoing process monitoring, ensuring process knowledge, manufacturing documentation, sampling plans, comparability strategies, and continued process verification approaches are fit for purpose.
• Provide technical guidance for process troubleshooting, deviation investigations, root-cause analyses, CAPAs, change controls, process performance trending, and technical impact assessments in collaboration with Quality and external partners to support validation, launch, and commercial supply.
• Review and approve CDMO technical documents, including protocols, batch records, campaign plans, development reports, deviation assessments, technical memos, and manufacturing documentation.

Regulatory:

• Partner with the CMC team to author, review, and defend technical content for CMC regulatory filings, agency questions, and briefing materials.
• Accountable for regulatory submission content and comparability strategy for new manufacturing sites, scale-ups, process improvements and changes.

People Management:

• • Lead, mentor, and develop internal technical MSAT team members fostering scientific rigor, accountability, collaboration, urgency, and pragmatic decision-making.
  • Provide career development guidance, coaching, performance feedback, and succession planning for team members.
  • Allocate resources effectively across programs and ensure MSAT priorities are aligned with organizational objectives, program milestones, commercial readiness needs, and available capacity.
  • Build scalable MSAT processes, templates, technical governance routines, knowledge-management practices, and best practices appropriate for a growing biotech organization operating through external partners.
  • Promote technical excellence through coaching, training, knowledge sharing, and transparent communication across internal teams and CDMO partners.

Requirements

• 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, with the ability to translate process knowledge into practical manufacturing controls.
• Deep expertise in Quality by Design (QbD), with advanced knowledge of cGMP expectations and relevant FDA, EMA, ICH, and other global CMC guidance and regulatory requirements.
• Proven 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 thinker with the discipline and execution focus to translate vision into operational results. Skilled at leading through influence, particularly in remote and matrixed environments.
• High standards of quality, accountability, and urgency with the resilience to thrive in a fast-paced environment.
• Collaborative, team-oriented approach balanced with the decisiveness required of a technical leader.
• Ability to travel domestically and internationally up to 10%, with additional travel as business needs require.

Work Location and Conditions:

•  At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations candidates must be able to attend meetings at our office in Cambridge, MA on a regular basis.  Preference will be given to candidates who reside in the New England region and can be in person on an as needed basis.
• When working remotly, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.