Lyra Therapeutics (Nasdaq: LYRA) is a clinical-stage company pioneering a new therapeutic approach to treat debilitating ear, nose and throat (ENT) diseases that impact the lives of millions of people. Our goal is to transform the ENT treatment paradigm by providing effective front-line solutions for physicians and new treatment options for their patients. In a Phase 1 study, the company observed a rapid, clinically meaningful and durable improvement in symptom score, with 90% of Chronic Rhinosinusitis (CRS) patients having improved symptoms at 24 weeks. A positive Phase 2 study readout of LYR-210 for the treatment of chronic rhinosinusitis with and without nasal polypsis was recently announced and LYR-220 is expected in the clinic next year. Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology.
We are currently seeking an experienced Principal Quality Engineer to manage the operations within our Quality Assurance department and the contract sites involved in the production of our combination products for clinical and commercial activities. Reporting to the VP, Quality, the Engineer will be responsible for reviewing design control deliverables and supporting continuous improvement efforts for manufacturing related activities. They will also oversee quality Risk Management, Design Assurance and Human Factors Engineering review. The successful candidate will be a collaborative team player with experience in a fast-growing medical device/combination product company, and experience working closely with CMO’s.
Key Areas of Responsibility:
• Apply sound engineering principles and practices to the design, development, and testing of biomaterials-based, drug delivery implants, and their delivery systems
• Develop protocols, set up, and utilize bench and preclinical models to evaluate performance of innovative bioresorbable therapies
• Manage key suppliers on the design and procurement of tooling and fixtures that aid in product development, testing, and/or inspection
• Manage design assurance & product development activities with key external vendors
• Collaborate with team on due diligence, review of change controls, deviations, batch review, maintaining Design History File (DHF) and product disposition
• Provide support to build effective quality systems and continuous improvement activities
• Document development activities in technical reports and lab notebooks
• Write work instructions, test methods, batch records, study protocols and other technical documents related to product development and manufacturing
• Lead the risk management & quality assurance design control deliverables as products progress through development
• Collaborate with clinical function to prepare documents related to product use
• Lead the preparation of regulatory submissions, scientific/engineering papers, grant applications, invention disclosures, and patents
• Execute timelines and milestones as part of project planning
• Collaborate with project teams & external vendors to ensure compliance to appropriate ISO/FDA regulations for the design and manufacture of human use products
• Manage team of Engineering Technicians
• B.S. in Engineering or related discipline required, advanced degree preferred
• 13+ years of hands on experience in the development of pharmaceutical devices and/or combination products.
• Knowledge of GxP and FDA Quality System requirements, 21 CFR 820, MDR 2017/745, and ISO 13485 (Quality System) requirements
• Knowledge in human factors engineering, design controls, documentation, specification development, testing, and risk management required
• Experience in the assessment, development and/or manufacture of combination products required
• Excellent documentation skills, e.g., reports, requirements, and specifications
• Must be able to analyze / synthesize data and communicate issues, findings, processes and ideas in a clear, concise, technically-proficient manner
• Collaborative team player with excellent communication skills who enjoys working in a highly dynamic, cross-disciplinary environment
At Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable. We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team. For consideration, please submit cover letter and CV.
Please visit www.lyratx.com for more information.