Department: Quality
Position Type: Exempt
Status: Full-Time
Location: Remote

Company Overview

Alzheon, Inc. is a clinical-stage biopharmaceutical company developing a broad portfolio of product candidates and diagnostic assays for patients suffering from Alzheimer’s disease and other neurodegenerative disorders. We are committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Our lead Alzheimer’s clinical candidate, ALZ-801, is an oral agent in Phase 3 development as a potentially disease modifying treatment for AD. ALZ-801 is an oral small molecule that fully blocks formation of neurotoxic soluble amyloid oligomers in the brain. Our clinical expertise and technology platform are focused on developing drug candidates and diagnostic assays using a precision medicine approach based on individual genetic and biomarker information to advance therapies with the greatest impact for patients.

Our experienced and passionate drug development team is focused on applying precision medicine, cutting-edge disease biomarkers, brain imaging and unique biologic insights to advance therapies with the greatest impact for patients. We are seeking individuals with an entrepreneurial spirit to join our team and help make the first oral Alzheimer’s disease-modifying therapy a reality for patients and their families, in a few short years.

Position Overview

The Manger of GMP Quality assurance works closely with Alzheon’s CMC organization to provide GMP QA expertise and oversight of contract manufacturing organizations supplying investigational and commercial drug substance, drug product and finished goods for Alzheon.

Key Responsibilities

• Support GMP QA activities spanning across CMC (Chemistry, Manufacturing & Controls) for drug substance, drug product, and supply chain/logistics operations, for all outsourced GMP clinical trial and commercial manufacturing
• Perform GMP Batch Release activities ensuring all drug substance, drug product and packaged and labelled investigational product and commercial batches meet GMP regulations and are released on time
• Review and approve master batch records, executed batch records, material specifications, and analytical documents
• Maintain GMP electronic document files in an organized and compliant manner
• Provide GMP QA expertise to the development of the commercial supply chain and ensure inspection readiness
• Support the development / amendment of Quality Assurance Agreements with GMP vendors and key raw material suppliers
• Support risk-based management activities including change control, deviation and CAPA management and the generation of quality metrics as needed
• Lead and support audits and associated vendor audit plans specifically supporting GMP activities
• Review CMC sections of regulatory filings to ensure consistency with applicable GMP regulated activities
• Support regulatory inspectional activities including at Alzheon and GMP contract manufacturing sites
• Support Computer System Validation process at Alzheon
• 10% of travel may be required
• All other duties as assigned

Requirements

• Minimum of 5+ years of experience in a GMP regulated industry, preferably biotech or pharmaceutical, performing quality assurance functions. Experience with solid dosage forms preferred
• Bachelor’s degree in related Chemistry, Biological Sciences or Engineering discipline, Masters preferred
• Experience in QA oversight of global GMP contract manufacturing organizations strongly preferred
• Extensive knowledge of GMP regulations, quality systems, quality assurance and quality control
• Extensive Analytical Method Validation experience
• Knowledge of risk management approaches in clinical phase and commercial manufacturing
• Ability to work both independently with minimal direction and within project teams, supporting multiple projects simultaneously
• Strong verbal / written communication and presentation skills
• Ability to work well in a deadline-driven environment
• Excellent computer skills in use of Microsoft Office (Excel, Word, PowerPoint)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

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