Director,Manufacturing Sciences and Technology; MSAT Job Cambridge area,Massachusetts USA,Manufacturing / Production

Job Description & How to Apply Below

Position: Director, Manufacturing Sciences and Technology (MSAT)
ResponsibilitiesMSAT 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