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Key Responsibilities:
- Provide QA oversight for sterile drug product manufacturing, labeling, packaging, and distribution.
- Review and approve process validation documents, master production records, and product specifications.
- Manage batch disposition and quality system records including deviations, CAPAs, and complaints.
Qualifications:
- Bachelor's degree with 5+ years in Quality Operations, QC, or MSAT; or advanced degree with 3+ years.
- At least 3 years hands-on experience in sterile or aseptic manufacturing environments.
- Experience with NDA CMC sections and regulatory filings in FDA, EMA, and ICH guidelines.
Work Environment:
- Remote position within the US, excluding certain states like Alaska, Arizona, Hawaii, Michigan, and Tennessee.
- Travel up to 10% within US for on-site reviews at third-party operations.
- Must have reliable internet, phone, and video conferencing capability.
Compensation and Benefits:
- Estimated pay range: $129,000 - $145,000 USD annually.
- Equal opportunity employer with accommodations available for candidates.
Amylyx Pharmaceuticals
Amylyx Pharmaceuticals is a clinical-stage company focused on treating diseases with high unmet needs, such as post-bariatric hypoglycemia, Wolfram syndrome, and ALS. The company has an experienced team driven by core values of audacity, curiosity, authenticity, engagement, and accountability, fostering a culture of caring.