Director, Manufacturing Sciences and Technology (MSAT)

SilverShoots; Cambridge (MA); On-site; USD 209,000 - 235,000; Full time

Job summary

Amylyx is seeking a Director, Manufacturing Sciences and Technology to establish MSAT capabilities for commercialization. Lead outsourced drug substance and product manufacturing, drive process validation, lifecycle management, and PPQ readiness with External Manufacturing, Quality, Regulatory CMC, and Supply Chain partners.

The role requires strong MSAT leadership in a fast-paced biotech, hands-on with technology transfers, process validation, and continual improvement, reporting to the Senior

Qualifications

• BA with 10+ years or MS with 8+ years in Chemical Engineering, Biological or Pharmaceutical Sciences.
• Deep expertise in Quality by Design (QbD) and global CMC guidance.
• Ability to influence across matrixed teams and external partners.

Responsibilities

• Lead MSAT strategy and technical leadership across late‑stage development to commercial manufacturing.
• Oversee technology transfer, process validation, PPQ, and lifecycle management.
• Provide regulatory content input and collaboration with CMC/regulatory teams.
• Mentor and develop the MSAT team; manage resources and priorities.
• Collaborate with External Manufacturing, Quality, and Supply Chain to resolve issues.

Skills

Leadership

Communication

Cross-functional collaboration

Technical writing

Executive-level presentation

Education

Bachelor's degree with 10 years'

Master's degree with 8+ years'

Job description

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

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.

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.

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.