CMC Quality Lead: Drug Substance & GMP Compliance

amylyx; Cambridge (MA); Hybrid; USD 129,000 - 145,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Benefits package

Job summary

Amylyx is seeking a CMC Quality Expert to provide leadership in the oversight of drug substance manufacturing, packaging, and distribution. You will ensure GMP, GDP, and regulatory standards are met and drive quality across the CMC functions with internal teams and external partners.

The role requires working with cross-functional teams, reviewing validation and lot records, and preparing regulatory documentation.

Qualifications

• Minimum 5 years of experience with a B.S. in Pharmaceutical Sciences.
• Minimum 3 years of experience directly related to peptide and/or oligonucleotide manufacturing, including quality operations, QC, MSAT, etc.
• Experience with authoring/reviewing NDA CMC sections and regulatory filings per FDA cGMP, Eudralex and ICH guidelines.

Responsibilities

• Provide quality oversight of drug substance production activities.
• Provide QA review/approval on drug substance validation docs, equipment validation docs, master production records, product specifications (in-process, release, stability).
• Review Batch Production and QC Control Records for compliance with procedures and specs.
• Prepare/approve batch disposition packages.
• Review/approve quality system records (deviations, OOS, CAPAs, PQCs).
• Lead/participate in QA meetings to ensure GMP, GDP, and GDP standards are met.
• Write/review/approve SOPs for manufacturing, labeling, packaging, and transportation of late-stage and commercial products.
• Provide QA review on NDAs and ensure traceability of source data for regulatory submissions.
• Support FDA/EMA or other regulatory inspections.

Skills

Quality Oversight

GMP compliance

GDP compliance

NDA CMC writing

Regulatory filings

Vendor management

Cross-functional collaboration

Education

BS in Pharmaceutical Sciences

MS/PhD in Pharmaceutical Sciences

Job description

Amylyx is seeking a CMC Quality Expert to provide leadership in the oversight of drug substance manufacturing, packaging, and distribution. You will ensure GMP, GDP, and regulatory standards are met and drive quality across the CMC functions with internal teams and external partners.

The role requires working with cross-functional teams, reviewing validation and lot records, and preparing regulatory documentation.