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 polyposis 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.

Our team is growing, and we are currently seeking an experienced Director, Quality Control to manage the Quality Control operations within Lyra and at the contract sites involved in the production of our combination products for clinical and commercial activities. Reporting to the Vice President, Quality the Director, Quality Control will be responsible for developing and leading the Quality Control function supporting both the inhouse and contract test laboratories. The successful candidate will be a team player with experience in a fast-growing combination drug product company, and the ability to successfully collaborate both internally and externally.

Key Areas of Responsibility:

  • Lead and oversee analyses of GMP raw materials, in-process materials, stability, and finished drug products

  • Develop and maintain Quality Control standard operating procedures and work instructions

  • Manage contract test laboratories conducting GMP testing and inspection

  • Compile and review data to ensure data integrity and regulatory compliance

  • Lead and oversee deviation and investigations related to Quality Control testing

  • Maintain Quality Control laboratory related systems to ensure compliance with industry standards and Lyra procedures

  • Provide Quality Control data and reports to support regulatory submissions

  • Provide support to build effective quality systems and continuous improvement activities

  • Apply scientific knowledge and understanding of industry practices to the testing of biomaterials-based, drug delivery implants, and their delivery systems

  • Collaborate with project teams & external vendors to ensure compliance to appropriate FDA regulations and ICH guidance for testing of combination drug products

  • BS or MS in Chemistry or a related scientific field with 10+ years of GMP laboratory experience

  • Experience with analytical methods and laboratory instrumentation

  • Experience of microbiological testing of raw materials and final product

  • Experience with clinical and commercial drug product testing including combination drug product method validation

  • Working knowledge of cGMP, ICH, USP, EU and FDA quality control requirements

  • Familiarity with method development/validation is preferred

  • 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.


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    Director, Quality Control Located At Ma, Watertown - Job Post By: Lyra Therapeutics, Inc.

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