Process Engineer
Amylyx Pharmaceuticals
June 26, 2026
Remote
United States
Operations
Responsibilities:
- Provide technical and GMP support for late-stage clinical and commercial aseptic drug product manufacturing at external CMOs.
- Serve as aseptic processing SME (sterile filtration, formulation, filling, container closure) and provide onsite support when required.
- Lead investigations, root cause analysis, and develop scientifically sound CAPAs.
- Author/assess technical risk assessments and change controls to support manufacturing changes and regulatory filings.
- Ensure compliance with cGMPs and global regulatory requirements/internal quality systems for aseptic manufacturing.
- Lead/support aseptic technology transfers from development to clinical/commercial sites.
- Define/transfer CPPs, CQAs, and in-process controls; develop/execute aseptic process validation strategies (PPQ planning, statistical sampling, acceptance criteria).
- Provide technical authorship/review for regulatory submissions (IND, BLA, NDA, MAA), validation reports, and responses to agency questions.
- Support new product introductions/commercial launches with validated, scalable, inspection-ready processes.
- Lead CPV and routine data trending (aseptic unit operations, environmental monitoring, CPPs); maintain dashboards/KPIs and provide quarterly CPV summaries.
- Identify process drift/contamination risk signals and drive CAPAs/preventive actions.
- Drive continuous improvement using QbD, statistical tools, and risk-based decisions; collaborate on best practices and process enhancements.
Required Qualifications:
- BS in engineering or related field with 5+ years, or MS with 3+ years relevant experience.
- Aseptic drug product manufacturing experience for late-stage development/commercial (device experience a plus).
- Proficiency in QbD, DoE, SPC, and complex data analysis.
- Strong cGMP and regulatory knowledge, including process/equipment/facility validation.
- Excellent communication/teamwork; detail-oriented with strong problem-solving.
- Travel to domestic/international CMOs as needed.
Preferred Qualifications:
- Familiarity with modeling/optimization tools (e.g., MATLAB, JMP).
Work Location/Conditions:
- Remote within the U.S. (not considering AK, AZ, HI, MI, or TN). Travel to Cambridge, MA several times/year and attend events as needed; must have reliable work setup (privacy, internet, phone, video conferencing).
Compensation:
- Estimated pay range: $131,000–$147,000 USD.
Application:
- Apply through the company’s website.
- Provide technical and GMP support for late-stage clinical and commercial aseptic drug product manufacturing at external CMOs.
- Serve as aseptic processing SME (sterile filtration, formulation, filling, container closure) and provide onsite support when required.
- Lead investigations, root cause analysis, and develop scientifically sound CAPAs.
- Author/assess technical risk assessments and change controls to support manufacturing changes and regulatory filings.
- Ensure compliance with cGMPs and global regulatory requirements/internal quality systems for aseptic manufacturing.
- Lead/support aseptic technology transfers from development to clinical/commercial sites.
- Define/transfer CPPs, CQAs, and in-process controls; develop/execute aseptic process validation strategies (PPQ planning, statistical sampling, acceptance criteria).
- Provide technical authorship/review for regulatory submissions (IND, BLA, NDA, MAA), validation reports, and responses to agency questions.
- Support new product introductions/commercial launches with validated, scalable, inspection-ready processes.
- Lead CPV and routine data trending (aseptic unit operations, environmental monitoring, CPPs); maintain dashboards/KPIs and provide quarterly CPV summaries.
- Identify process drift/contamination risk signals and drive CAPAs/preventive actions.
- Drive continuous improvement using QbD, statistical tools, and risk-based decisions; collaborate on best practices and process enhancements.
Required Qualifications:
- BS in engineering or related field with 5+ years, or MS with 3+ years relevant experience.
- Aseptic drug product manufacturing experience for late-stage development/commercial (device experience a plus).
- Proficiency in QbD, DoE, SPC, and complex data analysis.
- Strong cGMP and regulatory knowledge, including process/equipment/facility validation.
- Excellent communication/teamwork; detail-oriented with strong problem-solving.
- Travel to domestic/international CMOs as needed.
Preferred Qualifications:
- Familiarity with modeling/optimization tools (e.g., MATLAB, JMP).
Work Location/Conditions:
- Remote within the U.S. (not considering AK, AZ, HI, MI, or TN). Travel to Cambridge, MA several times/year and attend events as needed; must have reliable work setup (privacy, internet, phone, video conferencing).
Compensation:
- Estimated pay range: $131,000–$147,000 USD.
Application:
- Apply through the company’s website.