Director, Quality Control
Description

Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra's XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company's current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, is entering Phase 3 clinical development for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 3 development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management.  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 Head of Quality, the Director, Quality Control will be responsible for developing and leading the Quality Control function supporting both the in-house 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.


Responsibilities 

  • 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 guidances for testing of combination drug products
Requirements
  • BS or MS in Chemistry or a related scientific field with 10+ years of GMP laboratory experience 
  • Experience with analytical methods and 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.


Please visit www.lyratx.com for more information.