Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug anddelivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and other chronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stage development for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads to debilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naïve patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.
Our team is growing, and we are seeking an experienced Quality Assurance Specialist to join our Quality Group and play a critical role in ensuring the quality and compliance of our combination products. The Specialist will assist in the batch record review and release processes, contributing to the production of safe and effective pharmaceuticals.
- Batch Record Review: Collaborate with cross-functional teams to review batch records for completeness, accuracy, and compliance with GMP (Good Manufacturing Practices) regulations and company standards
- Product Release: Assist in the product release process by verifying that all necessary documentation and quality checks have been completed prior to release
- Quality Assurance: Ensure that all combination products meet the established quality standards and are in compliance with regulatory requirements
- Documentation: Maintain accurate and organized records related to batch record review and product release activities
- Continuous Improvement: Identify areas for process improvement and work with the QA team to implement best practices and drive efficiencies
- Training: Participate in training programs to expand your knowledge of GMP regulations and company procedures, ensuring a high level of competence in your role
- Communication: Effectively communicate quality-related issues and findings to relevant stakeholders, including production, regulatory affairs, and quality control teams
- Bachelor's degree in a relevant field (e.g., chemistry, biology, pharmaceutical sciences) with a minimum of 3 years of equivalent work experience
- Experience in pharmaceutical quality assurance, GMP, or related areas. Training will be provided to candidates with a strong foundational understanding of quality principles
- Knowledge of FDA and international regulatory requirements for pharmaceutical manufacturing; knowledge of GMPs for combination products is preferred
- Attention to detail and a strong commitment to maintaining high-quality standards
- Excellent communication and interpersonal skills
- Ability to work collaboratively in a team-oriented environment
- Strong problem-solving skills and a proactive attitude
- Adherence to ethical and safety standards in a pharmaceutical manufacturing 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.