Process Engineer
Amylyx Pharmaceuticals
11 days ago
Remote friendly (Cambridge, MA)
United States
Operations
Responsibilities:
- Provide technical and GMP support to CMOs for late-stage clinical and commercial aseptic drug product manufacturing (sterile filtration, formulation, filling, container closure).
- Serve as aseptic processing SME; provide onsite support when required.
- Lead investigations, root cause analysis, and CAPAs; ensure alignment with regulatory expectations and best practices.
- Author/assess technical risk assessments and change controls for investigations, manufacturing changes, and regulatory filings.
- Ensure compliance with cGMPs, regulatory requirements, and internal quality systems.
- Lead/support aseptic technology transfers from development to clinical/commercial sites.
- Define/transfer CPPs, CQAs, and in-process controls; develop and execute aseptic process validation (PPQ planning, statistical sampling plans, acceptance criteria).
- Author/review regulatory submission content (IND, BLA, NDA, MAA), validation reports, and responses to agency questions.
- Lead CPV and routine data trending (environmental monitoring, CPPs); maintain dashboards/KPIs and present quarterly summaries.
- Identify early signals of drift/contamination risk and drive corrective/preventive actions.
- Drive continuous improvement using QbD, statistical tools, and risk-based decision-making.
Required Qualifications:
- BS in engineering (or related) with 5+ years; or MS with 3+ years relevant experience.
- Experience in aseptic drug product manufacturing for late-stage development/commercial.
- Proficiency in QbD, DoE, SPC, and complex data analysis.
- Strong problem-solving, detail orientation, and trend identification.
- Knowledge of cGMP and regulatory requirements, including process/equipment/facility validation.
- Excellent communication and teamwork.
- Ability to travel to domestic/international CMOs as needed.
Preferred/Plus:
- Device experience.
- Familiarity with MATLAB/JMP or similar modeling/optimization tools.
Work Location/Conditions:
- Remote within the US; travel to Cambridge, MA several times/year and attend events as requested; must have reliable internet/phone/video capability.
- Provide technical and GMP support to CMOs for late-stage clinical and commercial aseptic drug product manufacturing (sterile filtration, formulation, filling, container closure).
- Serve as aseptic processing SME; provide onsite support when required.
- Lead investigations, root cause analysis, and CAPAs; ensure alignment with regulatory expectations and best practices.
- Author/assess technical risk assessments and change controls for investigations, manufacturing changes, and regulatory filings.
- Ensure compliance with cGMPs, regulatory requirements, and internal quality systems.
- Lead/support aseptic technology transfers from development to clinical/commercial sites.
- Define/transfer CPPs, CQAs, and in-process controls; develop and execute aseptic process validation (PPQ planning, statistical sampling plans, acceptance criteria).
- Author/review regulatory submission content (IND, BLA, NDA, MAA), validation reports, and responses to agency questions.
- Lead CPV and routine data trending (environmental monitoring, CPPs); maintain dashboards/KPIs and present quarterly summaries.
- Identify early signals of drift/contamination risk and drive corrective/preventive actions.
- Drive continuous improvement using QbD, statistical tools, and risk-based decision-making.
Required Qualifications:
- BS in engineering (or related) with 5+ years; or MS with 3+ years relevant experience.
- Experience in aseptic drug product manufacturing for late-stage development/commercial.
- Proficiency in QbD, DoE, SPC, and complex data analysis.
- Strong problem-solving, detail orientation, and trend identification.
- Knowledge of cGMP and regulatory requirements, including process/equipment/facility validation.
- Excellent communication and teamwork.
- Ability to travel to domestic/international CMOs as needed.
Preferred/Plus:
- Device experience.
- Familiarity with MATLAB/JMP or similar modeling/optimization tools.
Work Location/Conditions:
- Remote within the US; travel to Cambridge, MA several times/year and attend events as requested; must have reliable internet/phone/video capability.