Director, Manufacturing Sciences and Technology (MSAT)

Amylyx Pharmaceuticals; Cambridge (MA); Hybrid; USD 209,000 - 235,000; Full time

Job summary

Amylyx Pharmaceuticals seeks a senior MSAT leader to shape strategy and provide technical leadership across late-stage development, process validation, and commercial manufacturing. The role involves global coordination with external partners, ensuring process robustness, and advancing lifecycle management in a fast-paced biotech setting.

Responsibilities include developing transfer and qualification governance, mentoring an MSAT team, and aligning resources with program milestones while travel

Qualifications

• BA/BS or MS with 8–10+ years in chemical/biologic pharma or related field.
• Deep expertise in Quality by Design (QbD) and cGMP regulatory expectations (FDA/EMA/ICH).
• Proven ability to operate independently, influence without authority, and drive decisions in ambiguous settings.

Responsibilities

• Lead MSAT strategy and technical leadership across transfer, qualification, and process control.
• Coach teams across technology transfer, manufacturing support, and troubleshooting to drive operational excellence.
• Oversee PPQ, CPV, and lifecycle management with external partners and CDMOs.

Skills

Leadership

Communication

Collaboration

Technical writing

Executive presentation

Strategic thinking

Remote work

Travel flexibility

QbD

Education

Bachelor's/Master's in Chemical Engineering or related field

Job description

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.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Base salary is one component of Amylyx’s total rewards package. In addition to competitive base pay, eligible employees may receive annual performance-based bonuses and equity awards, providing an opportunity to share in the company’s long‑term success. Amylyx also offers a comprehensive benefits package designed to support the health, well-being, and financial security of our employees.

Estimated Pay Range$209,000—$235,000 USD

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.