In this role you will be responsible for quality oversight of external GMP Quality Operations and support for clinical-stage lentiviral-based gene therapies. The individual will be responsible for supporting our internal team, responsible for overseeing a network of global contract manufacturers and providing GMP Quality oversight both internally and externally.
- Provide subject matter expertise in the manufacture of AVROBIO clinical-stage lentiviral-based gene therapies. Conduct Quality/Technical review of product quality-related issues pertaining to analytical methods and resulting data, equipment, process controls, validation activities, etc.
- Review batch records and analytical data for conformance to specifications, regulations and disposition of clinical-stage batches for human use.
- Proactively and effectively communicate with contract manufacturers to address and resolve complex and routine activities while building positive client/vendor relationships, fostering continuous improvement and adding value to our internal CMC team.
- Manage product technical investigations (deviations, out of trend, out of specification, product complaints, CAPAs) associated with manufacturing operations and analytical/stability testing.
- Review and approve documentation, including Master Production Records, Specifications, Test Methods, Stability Protocols, Validation Protocols/Reports, Change Control Documentation and Labeling in support of work at our CMOs.
- Develop internal SOPs.
- Review IMPDs, DSURs, INDs, BLAs and associated technical documents as needed.
- Manage and report Quality Metrics and conduct annual product reviews.
- Additional Quality project work may be assigned as business needs arise.
- Bachelor’s degree in a related scientific field.
- Minimum of 12+ years of Quality Assurance/Manufacturing Operations experience in pharmaceutical or biotech industry.
- In-depth knowledge of GMP and QA principles, practices and standards; thorough understanding of FDA, EMA and ICH quality regulations.
- Ability to build relationships with internal stakeholders and external vendor/partners, and influence across disciplines and all levels.
- Highly motivated, flexible, with excellent organizational skills and keen attention to detail.
- Strong team player with a solutions-oriented, customer-service approach.
- Experience with Regulatory/Health Authority Inspections.
- Excellent verbal and written communication skills to effectively communicate with site staff and vendors.
- Gene therapy experience is desired, but not required.
- Ability to travel as needed, may be up to 30%.
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AVROBIO, Inc is an EEO employer
AVROBIO, Inc., a leader in lentiviral-based gene therapies, is a clinical-stage company developing disruptive therapies that have the potential to transform patients’ lives with a single dose. The Company is focused on the development of its gene therapy candidate, AVR‑RD‑01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, Cystinosis and Pompe disease. AVROBIO’s lentiviral platform has broad potential for other rare and non-rare genetic diseases. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON.