Amylyx Pharmaceuticals

Process Engineer, Drug Product

Cambridge, MA

Sponsorship not specified$131k-$147kDetected 6 days ago

MATLABData AnalysisRecruitingGMPLeadershipCommunicationProblem Solving

About the role

Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.
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.

Commercial & Clinical Aseptic Manufacturing Support:
Support technical leadership and day‑to‑day aseptic process engineering support for clinical and commercial drug product manufacturing at external CMOs.
Lead investigations, perform rigorous root cause analysis and develop scientifically sound CAPAs, ensuring alignment with regulatory expectations and industry best practices.
Assess and author technical risk assessments and change controls to support manufacturing changes, investigations, and regulatory filings.
Lead and support aseptic drug product technology transfer activities from development to clinical and commercial manufacturing sites.
Develop and execute aseptic process validation strategies, including PPQ planning, statistical sampling plans, and acceptance criteria aligned with regulatory guidance.
Support new product introductions and commercial launches by ensuring validated, scalable, and inspection‑ready aseptic processes.
Lead continued process verification (CPV) and routine data trending for aseptic unit operations, environmental monitoring, and critical process parameters.
Develop and maintain data repositories, dashboards, and meaningful KPIs to assess aseptic process capability and performance.
Identify early signals of process drift or increased contamination risk and proactively drive corrective or preventive actions.

Bachelor's degree in engineering or related field with 5+ years/ Master's with 3+ years of relevant experience.
Proficiency in Quality by Design (QbD), Design of Experiments (DoE), statistical process control (SPC), and complex data analysis.
Detail-oriented with strong problem-solving skills and ability to identify subtle trends in data.
Ability to travel to domestic and international CMOs as needed.

Prior experience in aseptic drug product manufacturing for late-stage development/commercial is required.
Device experience is a plus.
Familiarity with modeling and optimization tools (e.g., MATLAB, JMP) is a plus.

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks.
Estimated Pay Range
$131,000 - $147,000 USD
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.

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs.
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.

If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

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 condition

This listing is sourced directly from Amylyx Pharmaceuticals's careers page and normalized into a canonical job model.